AUTHORITY: Implementing the Pharmacy Practice Act [225 ILCS 85] and authorized by Section 2105-15 of the Civil Administrative Code of Illinois [20 ILCS 2105/2105-15].

SOURCE: Rules and Regulations Promulgated for the Administration of the Illinois Pharmacy Practice Act, effective August 20, 1975; amended March 8, 1977; amended at 4 Ill. Reg. 1234, effective July 11, 1980; amended at 5 Ill. Reg. 2997, effective March 11, 1981; codified at 5 Ill. Reg. 11049; emergency amendment at 6 Ill. Reg. 916, effective January 6, 1982, for a maximum of 150 days; amended at 6 Ill. Reg. 7448, effective June 15, 1982; amended at 7 Ill. Reg. 6496, effective June 30, 1983; amended at 9 Ill. Reg. 16918, effective October 23, 1985; amended at 10 Ill. Reg. 21913, effective December 17, 1986; transferred from Chapter I, 68 Ill. Adm. Code 330 (Department of Registration and Education) to Chapter VII, 68 Ill. Adm. Code 1330 (Department of Professional Regulation) pursuant to P.A. 85-225, effective January 1, 1988, at 12 Ill. Reg. 2957; amended at 12 Ill. Reg. 17394, effective October 14, 1988; amended at 16 Ill. Reg. 19811, effective December 7, 1992; amended at 21 Ill. Reg. 12600, effective August 29, 1997; amended at 22 Ill. Reg. 21959, effective December 1, 1998; amended at 23 Ill. Reg. 14131, effective November 18, 1999; amended at 24 Ill. Reg. 8548, effective June 9, 2000; amended at 26 Ill. Reg. 18338, effective December 13, 2002; amended at 27 Ill. Reg. 19389, effective December 11, 2003; emergency amendment at 29 Ill. Reg. 5586, effective April 1, 2005, for a maximum of 150 days; amended at 29 Ill. Reg. 13639, effective August 25, 2005; amended at 30 Ill. Reg. 14267, effective August 21, 2006; amended at 30 Ill. Reg. 16930, effective October 12, 2006; emergency amendment at 31 Ill. Reg. 16045, effective November 19, 2007, for a maximum of 150 days; amended at 32 Ill. Reg. 3262, effective February 21, 2008; amended at 32 Ill. Reg. 7116, effective April 16, 2008; old Part repealed at 34 Ill. Reg. 6688, effective April 29, 2010; new Part adopted at 34 Ill. Reg. 6690, effective April 29, 2010; amended at 39 Ill. Reg. 6267, effective April 23, 2015; amended at 41 Ill. Reg. 10643, effective August 18, 2017; amended at 42 Ill. Reg. 20022, effective November 9, 2018; amended at 47 Ill. Reg. 8352, effective June 2, 2023; amended at 48 Ill. Reg. 10225, effective June 28, 2024.

SUBPART A: GENERAL PROVISIONS

 

Section 1330.10  Definitions

 

"Act" means the Pharmacy Practice Act [225 ILCS 85].

 

"Automated Dispensing and Storage Systems" include, but are not limited to, mechanical systems that perform operations or activities, other than counting, compounding or administration, relative to the storage, packaging or dispensing of medications, and that collect, control and maintain all transaction information. 

 

"Beyond Use Date" means a drug's expiration date.

 

"Board" means the State Board of Pharmacy.

 

"Community Pharmacy" means any pharmacy that engages in general community pharmacy practice and that is open to, or offers pharmacy service to, the general public.

 

"Deliver" means the actual, constructive or attempted transfer of possession of a prescription medication.

 

"Department" means the Department of Financial and Professional Regulation.

 

"Direct Supervision" means in the immediate physical presence of the person supervised.

 

"Director" means the Director of the Division of Professional Regulation with the authority delegated by the Secretary.

 

"Dispense" means to interpret, verify computer entry of, select the prescribed product for, prepare and/or deliver a prescription medication to an ultimate consumer or to a person authorized to receive the prescription medication by or pursuant to the lawful order of a practitioner, including the compounding, packaging and/or labeling necessary for delivery and any recommending, advising and counseling concerning the contents, therapeutic values, uses and any precautions, warnings and/or advice concerning consumption.  Dispense does not mean the physical delivery to a patient or a patient's representative in a home or institution by a designee of a pharmacist or by common carrier or the physical delivery of a drug or medical device to a patient or patient's representative by a pharmacist's designee within a pharmacy or drugstore while the pharmacist is on duty and the pharmacy is open.

 

"Dispensing Error" means any preventable event that may cause or lead to inappropriate medication use or patient harm. Such events may be related to professional practice, health care products, procedures and systems, including: prescribing; order communication; product labeling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.

 

"Distribute" means to deliver, other than by dispensing, a prescription medication.

 

"Division" means the Department of Financial and Professional Regulation-Division of Professional Regulation.

 

"Drug Compliance Coordinator" means the chief pharmacy coordinator, appointed by the Secretary, who shall serve as the executive administrator and the chief enforcement officer of the Act, pursuant to Section 11(d) of the Pharmacy Practice Act.

 

"Drug Regimen Review" means and includes the evaluation of prescription drug orders and patient records for:

 

known allergies;

 

drug or potential therapy contraindications;

 

reasonable dose, duration of use, and route of administration, taking into consideration factors such as age, gender, and contraindications;

 

reasonable directions for use;

 

potential or actual adverse drug reactions;

 

drug-drug interactions;

 

drug-food interactions;

 

drug-disease contraindications;

 

therapeutic duplication;

 

patient laboratory values when authorized and available;

 

proper utilization (including over or under utilization) and optimum therapeutic outcomes; and

 

abuse and misuse [225 ILCS 85/3(y)].

 

"Electronic Format" includes, but is not limited to, information obtained via the Internet or stored on personal digital assistant, smart phone, tablet, etc.

 

"Electronic Transmission of Prescriptions" and "electronically transmitted prescriptions" means the communication of original prescriptions, refill authorizations, or medication orders, including controlled substances to the extent permitted by federal law, from an authorized licensed prescriber, or his or her authorized agent, to the pharmacy of the patient's choice by electronic means, including, but not limited to, telephone, facsimile machine, computer, computer modem or any other electronic device or authorized means.

 

"Institutional Pharmacy" means any pharmacy that is located in or outside a facility licensed under the Nursing Home Care Act [210 ILCS 45], the Hospital Licensing Act [225 ILCS 85], or the University of Illinois Hospital Act [110 ILCS 330] or a facility that is operated by the Department of Human Services or the Department of Corrections, and that provides pharmacy services to residents or patients of the facility, as well as employees, prescribers and students of the facility.

 

"Home Pharmacy" means the location of a pharmacy's primary operations.

 

"Medication Order" means a prescription issued by a physician or other authorized prescriber for a resident or patient of a facility served by an institutional pharmacy.

 

"Nonresident Pharmacy" means a pharmacy that is located outside this State that ships, delivers, dispenses or distributes into Illinois by any means any drugs, medicines, pharmaceutical services or devices requiring a prescription.

 

"Nuclear Pharmacist" means a pharmacist who provides radiopharmaceutical services and has satisfied the requirements of Section 1330.540(i).

 

"Nuclear Pharmacy" means any pharmacy that provides and/or offers for sale radiopharmaceuticals.

 

"On File" as used in Section 19 of the Act and this Part means the maintenance at the transferor pharmacy of the transferred prescription, whether previously filled or unfilled. For previously filled prescriptions at a transferor pharmacy located in Illinois, the prescriptions shall be maintained pursuant to the recordkeeping requirements of Section 18 of the Act.  For previously unfilled prescriptions at a transferor pharmacy located in Illinois, the prescriptions shall be maintained in a readily retrievable format in a suitable book, file or recordkeeping system for a period of not less than 5 years.  For previously filled and unfilled prescriptions at a transferor pharmacy located in a state other than Illinois, the prescriptions shall be maintained pursuant to the recordkeeping requirements of that state.

 

"Patient Counseling" means the communication between a pharmacist or a student pharmacist under the supervision of a pharmacist and a patient or the patient's representative about the patient's medication or device for the purpose of optimizing proper use of prescription medications or devices.  "Patient counseling" may include without limitation:

 

obtaining a medication history;

 

acquiring a patient's allergies and health conditions;

 

facilitation of the patient's understanding of the intended use of the medication;

 

proper directions for use;

 

significant potential adverse events;

 

potential food-drug interactions; and

 

the need to be compliant with the medication therapy.

 

A pharmacy technician may only participate in the following aspects of patient counseling under the supervision of a pharmacist:

 

obtaining medication history;

 

providing the offer for counseling by a pharmacist or student pharmacist; and

 

acquiring a patient's allergies and health conditions. [225 ILCS 85/3(r)]

 

"Patient Profiles" or "Patient Drug Therapy Record" means the obtaining, recording and maintenance of patient prescription and personal information.

 

"Pharmacist" means a currently licensed pharmacist.

 

"Pharmacy Services" means the provision of any services listed within the definition of the "practice of pharmacy" found in Section 3(d) of the Act.

 

"Radiopharmaceutical" means any substance defined as a drug in Section 3(b) of the Act that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any nonradioactive reagent kit or nuclide generator that is intended to be used in the preparation of any such substance but does not include drugs such as carbon-containing compounds of potassium-containing salts that contain trace quantities of naturally occurring radionuclides.  Radiopharmaceuticals include radioactive biological products as defined in the Federal Food, Drug and Cosmetic Act (21 USC 301 et seq.) and regulations promulgated under that Act.

 

"Radiopharmaceutical Quality Assurance" means, but is not limited to, the performance of appropriate chemical, biological and physical tests on potential radiopharmaceuticals, and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history and the keeping of proper records in these regards.

 

"Radiopharmaceutical Service" means the compounding, dispensing, labeling and delivery of radiopharmaceuticals; the participation in radiopharmaceutical selection and radiopharmaceutical utilization reviews; the proper and safe storage and distribution of radiopharmaceuticals as determined by the Illinois Emergency Management Agency; the maintenance of radiopharmaceutical quality assurance; the responsibility for advising, where necessary or required, of diagnostic and therapeutic values, hazards and use of radioactive pharmaceuticals; and the offering or performance of those acts, services, operations or transactions necessary in the conduct, operation, management and control of a nuclear pharmacy.

 

"Registrant" means a licensed pharmacist, registered assistant pharmacist, certified pharmacy technician, student pharmacist, or registered pharmacy technician.

 

"Remote Consultation Site" means a location, other than that of the home pharmacy, where prescriptions filled at the home pharmacy are stored and dispensed by a pharmacy technician, certified pharmacy technician and/or student pharmacist under the direct, remote supervision of a pharmacist located at, or contracted with, the home pharmacy.

 

"Remote Dispensing Site" means a location other than that of the home pharmacy where a supply of prescription drugs is maintained and prescriptions are filled and dispensed by a certified pharmacy technician and/or student pharmacist under the direct, remote supervision of a pharmacist located at, or contracted with, the home pharmacy.

 

"Remote Medication Order Processing" means receiving, interpreting or clarifying medication orders; data entry and transferring of medication order information; performing drug utilization review; interpreting clinical data; performing therapeutic interventions; and providing drug information concerning medication orders or drugs from a remote pharmacy.

 

"Remote Pharmacy" means any pharmacy that provides pharmacy services at a location other than the home pharmacy.

 

"Secretary" means the Secretary of the Department of Financial and Professional Regulation.

 

"Student Pharmacist" means a person registered as a pharmacy technician who is enrolled in a pharmacy program and is designated as a "student pharmacist" pursuant to Section 9 of the Act.

 

"Ultimate Consumer" means the person for whom a drug is intended.

 

"Unique Identifier" means an electronic signature, handwritten signature or initials, thumb print or other acceptable individual biometric or electronic identification process approved by the Division.

 

(Source:  Amended at 39 Ill. Reg. 6267, effective April 23, 2015)

 

Section 1330.20  Fees

 

The following fees are not refundable:

 

a)         Registration as a Pharmacy Technician, Student Pharmacist or Certified Pharmacy Technician

 

1)         The fee for application for a certificate of registration as a pharmacy technician, student pharmacist, or certified pharmacy technician is $40.

 

2)         The fee for the renewal of a certificate of registration as a pharmacy technician, student pharmacist or certified pharmacy technician shall be calculated at the rate of $25 per year.

 

b)         License as a Pharmacist

 

1)         The fee for application for a license as a pharmacist is $75.

 

2)         In addition, applicants for any examination as a registered pharmacist shall be required to pay, either to the Division or to the designated testing service, a fee covering the cost of determining an applicant's eligibility and providing the examination.  Failure to appear for the examination on the scheduled date, at the time and place specified, after the applicant's application for examination has been received and acknowledged by the Division or the designated testing service, shall result in the forfeiture of the examination fee.

 

3)         The fee for a license as a registered pharmacist, registered or licensed under the laws of another state or territory of the United States, is $200.

 

4)         The fee for the renewal of a license shall be calculated at the rate of $75 per year.

 

5)         The fee for the restoration of a license other than from inactive status is $50 plus all lapsed renewal fees, not to exceed $450.

 

6)         Applicants for the preliminary diagnostic examination shall be required to pay, either to the Division or to the designated testing service, a fee covering the cost of determining an applicant's eligibility and providing the examination.  Failure to appear for the examination on the scheduled date, at the time and place specified, after the application for examination has been received and acknowledged by the Division or the designated testing service, shall result in the forfeiture of the examination fee.

 

c)         License as a Pharmacy

 

1)         The fee for application for a license for a pharmacy under the Act is $100.

 

2)         The fee for the renewal of a license for a pharmacy under the Act shall be calculated at the rate of $100 per year.

 

3)         The fee for the change of a pharmacist-in-charge is $25.

 

d)         General Fees

 

1)         The fee for the issuance of a license with a change of name or address other than during the renewal period is $20.  No fee is required for name and address changes on Division records when no duplicate certification is issued.

 

2)         The fee for a certification of a registrant's record for any purpose is $20.

 

3)         The fee to have the scoring of an examination administered by the Division reviewed and verified is $20.

 

(Source:  Amended at 47 Ill. Reg. 8352, effective June 2, 2023)

 

Section 1330.30  Unprofessional and Unethical Conduct

 

Unprofessional and unethical conduct by a licensee or registrant shall include, but not be limited to:

 

a)         Failing to establish and maintain effective controls against diversion of prescription drugs.

 

b)         Committing theft or diversion, or attempting to commit theft or diversion, by a registrant or licensee.

 

c)         Making or filing a report or record that a pharmacist or pharmacy knows to be false or intentionally or negligently failing to file a report or keep records as required by the Act or this Part.

 

d)         Knowingly dispensing a prescription drug after the death of the person for whom the prescription was written.

 

e)         Billing or charging for quantities of drugs greater than that which was delivered or charging patients for a brand drug when a generic is dispensed.

 

f)         Submitting fraudulent billing or reports to a third party payer or claiming a fee for a service that is not performed or earned.

 

g)         Filling a prescription when a pharmacist knows, or reasonably should know, that no valid physician-patient relationship exists or failing to exercise sound professional judgment with respect to the accuracy and authenticity of any prescription/drug order dispensed.

 

h)         Failing to provide patient counseling in accordance with this Part, failing to respond to requests for patient counseling, attempting to circumvent patient counseling requirements, or otherwise discouraging patients from receiving patient counseling concerning their prescription medications.

 

i)          Discriminating in any manner against a person or group based upon that person or group's religion, race, creed, color, gender, sexual orientation, age or national origin.

 

j)          Knowingly dispensing a prescription drug without a valid prescription.  Dispensing or offering to dispense any drug not approved by the Food and Drug Administration (FDA), found in the USP-NF, or found on the list promulgated by the FDA for bulk drug substances that may be used to compound drug products.

 

k)         Failing to keep one's self and one's apparel clean or to wear identification bearing name and designation.

 

l)          Directly or indirectly furnishing to a medical practitioner prescription order-blanks that refer to a specific pharmacist or pharmacy in any manner.

 

m)        Actively or passively participating in any arrangement or agreement in which a prescription order-blank is prepared, written, or issued in a manner that refers to a specific pharmacist or pharmacy.  Pharmacy-branded enrollment forms, when a patient requests his or her prescriptions be filled at a specific pharmacy, and Risk Evaluation and Mitigation Strategies documents containing prescription information are not prohibited by this subsection.

 

n)         Dividing a prescription order unless directed by the prescriber, payer or patient or when the full quantity of that prescription medication is not available at that location.

 

o)         Committing dispensing errors that result in hospitalization of a patient or demonstrating a pattern and practice of dispensing errors.

 

p)         Committing an act or acts that are of a flagrant and obvious nature so as to constitute conduct of such a distasteful nature that accepted codes of behavior or codes of ethics are breached.

 

q)         Committing an act or acts in a relationship with a patient that violate common standards of decency or propriety.

 

r)          Willfully violating, or knowingly assisting in the violation of, any law relating to the use of habit-forming controlled substances.

 

(Source:  Amended at 41 Ill. Reg. 10643, effective August 18, 2017)

 

Section 1330.40  Violations

 

a)         A registrant shall not:

 

1)         Engage in a business relationship, with any place defined as a drug store or pharmacy in the Act where the practice of pharmacy is engaged in by any person who is not authorized to practice under the Act or that is not operated and conducted in compliance with the Act.

 

2)         Compound, sell or offer for sale, or cause to be compounded, sold or offered for sale, any drug, medicine, poison, chemical or pharmaceutical preparation, under or by a name recognized in the United States Pharmacopeia/National Formulary for internal or external use that differs from standard of strength, quality, purity or bioavailability as determined by the tests specified in the United States Pharmacopeia/National Formulary that is official at the time of the compounding, sale or offering for sale.

 

3)         Compound, sell or offer for sale, or willfully cause to be compounded, sold or offered for sale, any drug, medicine, poison, chemical or pharmaceutical preparation the strength or purity of which falls below the professed standard of strength or purity under which it is sold.

 

4)         Purchase prescription drugs from any source that fails to meet provisions of the Wholesale Drug Distribution Licensing Act [225 ILCS 120].

 

b)         No registrant shall violate any of the following laws, or the rules or regulations promulgated pursuant to these laws, which relate to the practice of pharmacy:

 

1)         Illinois Food, Drug and Cosmetic Act [410 ILCS 620].

 

2)         Hypodermic Syringes and Needles Act [720 ILCS 635].

 

3)         Federal Food, Drug and Cosmetic Act (21 USC 301 et seq.).

 

4)         Federal Controlled Substances Act (21 USC 801 et seq.).

 

5)         Illinois Controlled Substances Act [720 ILCS 570].

 

6)         Cannabis Control Act [720 ILCS 550].

 

7)         Illinois Poison Prevention Packaging Act [430 ILCS 40].

 

8)         Poison Prevention Packaging Act of 1970 (15 USC 1471 et seq.).

 

9)         Wholesale Drug Distribution Licensing Act [225 ILCS 120].

 

c)         If a licensee or registrant is disciplined in another state, he or she must inform the Division within 60 days.

 

(Source:  Amended at 39 Ill. Reg. 6267, effective April 23, 2015)

 

Section 1330.50  Vaccinations/Immunizations

 

a)         Qualifications

 

1)         A pharmacist, or a student pharmacist or a pharmacy technician under the direct supervision of a pharmacist, may administer vaccinations/immunizations to persons who are 7 years of age or older pursuant to a valid patient specific prescription or a standing order by a physician licensed to practice medicine in all of its branches under the Medical Practice Act of 1987 [225 ILCS 60].

 

2)         The pharmacist, student pharmacist, or pharmacy technician shall successfully complete a course of training accredited by the Accreditation Council on Pharmacy Education, or a similar health authority or professional body approved by the Division.  The pharmacist who is responsible for supervising the pharmacy student or pharmacy technician has the sole responsibility of evaluating the appropriateness of each vaccination prior to its administration and maintains full responsibility and oversight of the process.

 

3)         The pharmacist shall maintain a current Basic Life Support Certification for Healthcare Providers issued by the American Heart Association, the American Red Cross, the American Safety and Health Institute, or an equivalent as determined by the Division.

 

4)         Each pharmacy, or pharmacist functioning outside of a pharmacy, shall have available a current copy or electronic version of the CDC reference "Epidemiology and Prevention of Vaccine – Preventable Diseases" at the location where vaccinations are administered.

 

5)         The administration of vaccines shall be done by a pharmacist, or a student pharmacist or pharmacy technician under the direct supervision of a pharmacist, who has completed training as described in this Section.

 

b)         Protocols, Policies and Procedures

 

1)         Prior to administrating vaccinations/immunizations, a pharmacist, or a student pharmacist or a pharmacy technician under the direct supervision of a pharmacist, must follow protocols written by a physician licensed to practice medicine in all of its branches for the administration of vaccines and treatment of severe adverse events following administration of vaccines.

 

2)         The pharmacy must maintain written policies and procedures for handling and disposal of all used supplies or contaminated equipment. 

 

3)         The pharmacist, student pharmacist, or pharmacy technician under the direct supervision of a pharmacist, must give the appropriate vaccine information statement (VIS) to the patient or legal representative prior to each vaccination.  The pharmacist, or student pharmacist under the direct supervision of a pharmacist, must ensure that the adult patient or minor (age 7 and older) patient's parent or legal representative is available and has the vaccine information statement.

 

4)         The pharmacy must report adverse events as required by the Vaccine Adverse Events Reporting System (VAERS) and to the primary care provider named by the patient.

 

c)         Recordkeeping and Reporting

 

1)         All records regarding each administration of a vaccine must be kept for 5 years.  These records shall include:

 

A)        The name, address and date of birth of the patient.

 

B)        Date of administration and site of injection of the vaccine.

 

C)        Name, dose, manufacturer, lot number and beyond use date of the vaccine.

 

D)        Name and address of the patient's primary health care provider named by the patient.

 

E)        The name or unique identifier of the administering pharmacist.

 

F)         Which vaccine information statement (VIS) was provided.

 

2)         A pharmacist who administers or oversees the administration of any vaccine must ensure that the report of that administration, is made to the Illinois Comprehensive Automated Immunization Registry Exchange (I-CARE) or to the primary healthcare provider named by the patient within 30 days of administration.

 

(Source:  Amended at 47 Ill. Reg. 8352, effective June 2, 2023)

 

Section 1330.60  Internet Pharmacies

 

The provisions of the federal Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Ryan Haight Act) (21 USC 801 et seq.) and all federal regulations adopted under that Act, are expressly adopted by this Part.

 

Section 1330.70  Granting Variances

 

a)         The Director may grant variances from this Part in individual cases when he or she finds that:

 

1)         The provision from which the variance is granted is not statutorily mandated;

 

2)         No party will be injured by the granting of the variance; and

 

3)         The rule from which the variance is granted would, in the particular case, be unreasonable or unnecessarily burdensome.

 

b)         The Director shall notify the Board of the granting of the variance, and the reasons for granting the variance, at the next meeting of the Board.

 

Section 1330.80  Renewals

 

a)         Every license issued under the Act, except the certificate of registration as a pharmacy technician, shall expire on March 31 of each even-numbered year.  Every certificate of registration as a pharmacy technician issued under the Act shall expire annually on March 31.  The holder of a license or certificate of registration may renew the license or certificate during the 60 days preceding the expiration date by paying the required fee.

 

b)         It is the responsibility of each registrant to notify the Division of any change of address.  Failure to receive a renewal form from the Division shall not constitute an excuse for failure to pay the renewal fee.

 

c)         Practicing or operating on a license or certificate that has expired shall be considered unlicensed activity and shall be grounds for discipline pursuant to Section 30 of the Act.

 

d)         Pharmacy technicians shall be required to submit with their second renewal proof of certification as a certified pharmacy technician, proof of enrollment in a first professional degree program in pharmacy, or proof of enrollment in clinical training by a graduate a foreign pharmacy program, as provided in Section 9 of the Act. This requirement does not apply to pharmacy technicians licensed prior to January 1, 2008. Failure to provide proof of certification results in non-renewal of the pharmacy technician's registration.

 

(Source:  Amended at 39 Ill. Reg. 6267, effective April 23, 2015)

 

Section 1330.90  Restoration of a Pharmacist License

 

a)         A pharmacist seeking restoration of a certificate of registration that has expired for 5 years or less shall have the license restored upon payment of all lapsed renewal fees required by Section 1330.20 and proof of 30 hours of CE (e.g., certificate of attendance or completion) in accordance with Section 1330.100.

 

b)         A pharmacist seeking restoration of a certificate of registration that has been placed on inactive status for 5 years or less shall have the license restored upon payment of the current renewal fee and proof of 30 hours of CE (e.g., certificate of attendance or completion) in accordance with Section 1330.100.

 

c)         A pharmacist seeking restoration of a certificate of registration after it has expired or been placed on inactive status for more than 5 years shall file an application, on forms supplied by the Division, together with the fee required by Section 1330.20 and proof of 30 hours of CE (e.g., certificate of attendance or completion) in accordance with Section 1330.100.

 

1)         The pharmacist shall also submit either:

 

A)        Certification of active practice in another jurisdiction.  Evidence shall include a statement from the appropriate board or licensing authority in the other jurisdiction that the registrant was authorized to practice during the term of active practice; or

 

B)        An affidavit attesting to military service as specified in Section 12 of the Act. The applicant restoring a license shall be excused from the payment of any lapsed fee or any restoration fees.

 

2)         A pharmacist who is unable to submit proof of satisfaction of either subsection (c)(1)(A) or (B) shall submit proof of completion of:

 

A)        30 hours of CE; and

 

B)        Either:

 

i)          600 hours of clinical practice under the supervision of a licensed pharmacist completed within 2 years prior to restoration; or

 

ii)         Successful completion of the North American Pharmacist Licensure Examination (NAPLEX). To be successful, an applicant must receive a passing score of 75 on the NAPLEX.

 

3)         The course work or clinical training described in subsections (c)(2)(A) and (c)(2)(B)(i) must have the prior approval of the Board.

 

d)         When the accuracy of any submitted documentation, or the relevance or sufficiency of the course work or experience, is questioned by the Division because of lack of information, discrepancies or conflicts in information given, or a need for clarification, the registrant will be requested to:

 

1)         Provide information as may be necessary; and/or

 

2)         Appear for an interview before the Board to explain the relevance or sufficiency, clarify information given, or clear up any discrepancies in information.

 

(Source:  Amended at 47 Ill. Reg. 8352, effective June 2, 2023)

 

Section 1330.100  Continuing Education ("CE")

 

a)         CE Requirements

 

1)         Each person who applies for renewal of a license as a pharmacist shall complete 30 hours of CE during the 24 months preceding the expiration date of the license, in accordance with Section 12 of the Act.

 

2)         A renewal applicant is not required to comply with CE requirements for the first renewal after original licensure.

 

b)         Approved CE

 

1)         CE credit shall be based upon the completion of courses offered by providers approved by the Accreditation Council for Pharmacy Education.  These courses may be completed outside the State of Illinois.

 

2)         Undergraduate Coursework

 

A)        Undergraduate coursework taken after completion of a first professional degree in pharmacy through a recognized college or approved school of pharmacy (in accordance with Section 1330.300) may be used to fulfill the CE requirement if:

 

i)          Evidence of course completion through an official transcript and other documentation (e.g., certificate of completion or degree) of the university or college is submitted that indicates the number of course content hours completed; and

 

ii)         These courses are completed for college credit.

 

B)        CE credit will be earned for each undergraduate course completed. One semester hour is equivalent to 15 CE hours, and one quarter hour is equivalent to 10 CE hours.

 

c)         Certification of CE Requirements

 

1)         Each renewal applicant shall certify on the renewal application full compliance with CE requirements set forth in subsection (a).

 

2)         The Division may require additional evidence demonstrating compliance with the CE requirements.  It is the responsibility of each renewal applicant to retain or otherwise produce evidence of the compliance (e.g., certificate of attendance or completion).  Evidence shall be required in the context of the Division's random audit in accordance with Section 12 of the Act.

 

d)         The same CE hours cannot be used to fulfill the CE requirement for more than one renewal period.

 

e)         Waiver of CE Requirements

 

1)         Any renewal applicant seeking renewal of a license without having fully complied with these CE requirements shall file with the Division a renewal application, along with the required fee, a statement setting forth the facts concerning noncompliance and a request for waiver of the CE requirements on the basis of these facts.  A request for waiver shall be made prior to the renewal date.  If the Division, upon the written recommendation of the Board, finds from the affidavit or any other evidence submitted that good cause has been shown for granting a waiver, the Division shall waive enforcement of the CE requirements for the renewal period for which the applicant has applied.

 

2)         Good cause shall be defined as an inability to fulfill the CE requirements during the applicable period because of:

 

A)        Full-time service in the armed forces of the United States of America during the applicable period; or

 

B)        Extreme hardship, which shall be determined on an individual basis by the Board and shall be limited to documentation of:

 

i)          An incapacitating illness, documented by a currently licensed physician; or

 

ii)         Physical inability to travel to the sites of approved programs, as documented by a currently licensed physician; or

 

iii)        Any other similar extenuating circumstances (e.g., illness of family member).

 

3)         If a renewal applicant requests an interview before the Board at the time the waiver request is submitted, the Board shall not deny the waiver request before an interview is conducted.  The renewal applicant requesting a waiver shall be given at least 20 days written notice of the date, time and place of the interview by mail, or email.

 

4)         Any renewal applicant who submits a request for waiver pursuant to subsection (e)(1) shall be deemed to be in good standing until the final Division decision on the application has been made.

 

(Source:  Amended at 47 Ill. Reg. 8352, effective June 2, 2023)

 

Section 1330.110  Confidentiality

 

All information collected by the Department in the course of an examination or investigation of a licensee or applicant, including, but not limited to, any complaint against a licensee filed with the Department and information collected to investigate any such complaint, shall be maintained for the confidential use of the Department and shall not be disclosed. The Department shall not disclose the information to anyone other than law enforcement officials, regulatory agencies that have an appropriate regulatory interest as determined by the Secretary, or a party presenting a lawful subpoena to the Department. Information and documents disclosed to a federal, State, county or local law enforcement agency shall not be disclosed by the agency for any purpose to any other agency or person. A formal complaint filed against a licensee by the Department or any order issued by the Department against a licensee or applicant shall be a public record, except as otherwise prohibited by law.

 

(Source:  Added at 39 Ill. Reg. 6267, effective April 23, 2015)

SUBPART B: PHARMACY TECHNICIAN

 

Section 1330.200  Application for Certificate of Registration as a Pharmacy Technician

 

a)         An applicant for registration as a pharmacy technician shall file an application on forms supplied by the Division, together with:

 

1)         A copy of his or her high school diploma or its equivalent, or proof of current enrollment in a high school program; and

 

2)         The fee required by Section 1330.20.

 

b)         Pursuant to Section 9 of the Act, an applicant may assist a registered pharmacist for 60 days upon submission of an application or, submission for reinstatement not due to disciplinary action, to the Division in accordance with subsection (a).  A copy of the application must be maintained by the applicant at the site of employment during and until notice of registration or disqualification is received by the applicant and must be readily retrievable for review by the Drug Compliance Investigator.

 

c)         A pharmacy technician must renew his or her registration with the Division on an annual basis.

 

d)         Technician certificate of registration must be displayed and visible to the public in the pharmacy where the pharmacy technician is employed.

 

e)         Every registered pharmacy technician shall notify the Division of any change in the address on record within 30 days after the change.

 

f)         No pharmacist whose license has been denied, revoked, suspended or restricted for disciplinary purposes is eligible to be registered as a pharmacy technician.

 

g)         No person who holds an active Illinois pharmacist's license may concurrently hold an active Illinois pharmacy technician registration.

 

h)         Any pharmacy technician who is permitted to use the title "student pharmacist" pursuant to Section 9 of the Act shall notify the Division within 10 days if he or she has permanently separated from or been expelled from an ACPE accredited college or school of pharmacy; failed to complete his or her 1,200 hours of Board approved clinical training within 24 months; or failed the pharmacist licensure examination 3 times. When this occurs, the technician shall have 90 days to obtain a certified pharmacy technician license as provided in Section 1330.220, unless that certified pharmacy technician was registered prior to January 1, 2008. During the period prior to registering as a pharmacy technician, the individual is not permitted to use the title "student pharmacist". If the individual does not become registered as a certified pharmacy technician within 90 days, the pharmacy technician registration shall expire.

 

(Source:  Amended at 39 Ill. Reg. 6267, effective April 23, 2015)

 

Section 1330.210  Pharmacy Technician Training

 

a)         It shall be the joint responsibility of a pharmacy and its pharmacist-in-charge to have trained all of its pharmacy technicians or obtain proof of prior training in all of the following topics as they relate to the practice site:

 

1)         The duties and responsibilities of the technicians and pharmacists.

 

2)         Tasks and technical skills, policies and procedures.

 

3)         Compounding, packaging, labeling and storage.

 

4)         Pharmaceutical and medical terminology.

 

5)         Recordkeeping requirements.

 

6)         The ability to perform and apply arithmetic calculations.

 

b)         Within 6 months after initial employment or changing the duties and responsibilities of a pharmacy technician, it shall be the joint responsibility of the pharmacy and the pharmacist-in-charge to train the pharmacy technician or obtain proof of prior training in the areas listed in subsection (a) as they relate to the practice site or to document that the pharmacy technician is making appropriate progress.

 

c)         All pharmacies shall maintain an up to date training program describing the duties and responsibilities of a pharmacy technician.

 

d)         All pharmacies shall create and maintain retrievable records of training or proof of training as required in this Section.

 

e)         Ensuring registered pharmacy technicians and certified pharmacy technicians are properly trained shall be the responsibility of the pharmacy, the pharmacist-in-charge, and the pharmacy technician.

 

(Source:  Amended at 39 Ill. Reg. 6267, effective April 23, 2015)

 

Section 1330.215  Minimum Standards for Approved Work Experience Pharmacy Technician Certification

 

A pharmacy technician certification program shall meet the following requirements:

 

a)         This Section applies to pharmacy technicians licensed beginning January 1, 2024.

 

b)         The curriculum must include at least 500 hours of supervised experience.

 

c)         The work experience training under subsection (b) must be completed by the pharmacy technician's 2^nd renewal.

 

d)         Curriculum must include didactic and practical experience for each area of instruction.

 

e)         A graduate shall be competent in:

 

1)         The knowledge, skills, abilities, and behaviors beyond those of a pharmacy technician;

 

2)         Functioning in a variety of pharmacy practice settings; and

 

3)         Self-management and the management of the pharmacy.

 

f)         The curriculum must include the following areas of instruction:

 

1)         Knowledge and Skills:

 

A)        Ethics;

 

B)        Conflict resolution;

 

C)        Customer service;

 

D)        Communication with individuals, staff, and other healthcare professionals;

 

E)        Self-management skills; and

 

F)         Problem solving.

 

2)         Continuing Competency:

 

A)        Continuing education;

 

B)        Pharmacy technician's role and other occupations' roles in the healthcare environment;

 

C)        Basics in anatomy, pharmacology, and physiology relevant to pharmacy technician role;

 

D)        Pharmacy technician's role in the medication-use process;

 

E)        Infection control procedures;

 

F)         Protocols for vaccine administration;

 

G)        Common allergies; and

 

H)        Hygiene, personal protection equipment (PPE), cleaning and maintaining equipment.

 

3)         Medication Orders:

 

A)        Medication storage;

 

B)        Medication ordering;

 

C)        Recordkeeping;

 

D)        Medication labeling;

 

E)        Special handling procedures;

 

F)         Prescription entry and interpretation;

 

G)        Generic/brand names;

 

H)        Compounding sterile preparations per applicable, current USP chapters;

 

I)         Moderate and high level non-sterile compounding as defined by USP (e.g., suppositories, tablets, complex creams);

 

J)         Chemotherapy/hazardous drug preparations per applicable, current USP chapters;

 

K)        Billing for complex and/or specialized pharmacy services and goods;

 

L)        Purchasing pharmaceuticals, devices, and supplies;

 

M)       Inventory control of medications, equipment, and devices;

 

N)        Administration of immunizations and other injectable medications;

 

O)        Current technology/automation related to safety and accuracy of medication dispensing; and

 

P)         Dosage forms.

 

4)         Patient Care:

 

A)        Pharmacy technicians' role under the Joint Commission of Pharmacy Practitioners' Pharmacists' Patient Care Process;

 

B)        Patient and medication safety practices;

 

C)        Emergency patient situations;

 

D)        Medication reconciliation process;

 

E)        Medication management services;

 

F)         Measurements, preparation, and packaging;

 

G)        Point of care testing;

 

H)        Patient confidentiality;

 

I)         Error prevention;

 

J)         Safety event reporting; and

 

K)        Different insurance plan types, coupons, and prior authorizations.

 

5)         Regulatory Knowledge:

 

A)        Review of State and federal laws pertaining to processing, handling, and dispensing of medications, including controlled substances;

 

B)        Review of State and federal laws pertaining to pharmacy technicians;

 

C)        Occupational Safety and Health Administration (OSHA) requirements;

 

D)        USP requirements, including USP 795 and 797 training;

 

E)        The Institute for Safe Medication Practices (ISMP);

 

F)         The Joint Commission;

 

G)        Risk Evaluation and Mitigation Strategies (REMS);

 

H)        Look-Alike/Sound-Alike (LASA) High Alert;

 

I)         Health Insurance Portability and Accountability Act (HIPAA);

 

J)         Facility maintenance; and

 

K)        Medication disposal.

 

g)         Graduates must be competent in providing appropriate life support measures including Basic Life Support (BLS) and automated external defibrillators (AED), for medical emergencies that may be encountered in pharmacy practice.

 

h)         All programs accredited by the Accreditation Council for Pharmacy Education (ACPE) and the American Society of Health System Pharmacists (ASHP) meet the minimum curriculum criteria set forth in this Section and are, therefore, approved.

 

(Source:  Added at 48 Ill. Reg. 10225, effective June 28, 2024)

 

Section 1330.220  Application for Certificate of Registration as a Certified Pharmacy Technician

 

a)         An individual may receive certification as a certified pharmacy technician if the individual:

 

1)         Has submitted a written application in the form and manner prescribed;

 

2)         Has attained the age of 18;

 

3)         Is of good moral character, as determined by the Division;

 

4)         Graduated from a pharmacy technician training program approved by the Accreditation Council for Pharmacy Education (ACPE) or the American Society of Health System Pharmacists (ASHP) or obtained documentation from the pharmacist-in-charge of the pharmacy where the applicant is employed verifying that the applicant has successfully completed equivalent work experience of 500 hours as a pharmacy technician covering the practice areas set forth in Sections 17.1(a)(1) through (6) of the Act, or successfully completed work experience as provided for in Section 1330.215;

 

5)         Has successfully passed an examination accredited by the National Commission for Certifying Agencies of the Institute for Credentialing Excellence (NCCA), as approved and required by the Board.  The Division, upon the recommendation of the Board, has determined that the Exam for the Certification of Pharmacy Technicians offered by the Institute for the National Healthcareer Association (or its successor), and the Pharmacy Technician Certification Examination offered by the Pharmacy Technician Certification Board (or its successor), are accredited by NCCA and are, therefore, approved examinations for certification; and

 

6)         Has paid the required certification fees.

 

b)         No pharmacist whose license has been denied, revoked, suspended or restricted for disciplinary purposes is eligible to be registered as a certified pharmacy technician. No person who holds an active Illinois pharmacist license may concurrently hold an active Illinois certified pharmacy technician registration.

 

(Source:  Amended at 48 Ill. Reg. 10225, effective June 28, 2024)

 

Section 1330.230  Continuing Education (“CE”) for Certified Pharmacy Technicians

 

a)         CE Requirements

 

1)         Number of Hours of CE Required

 

A)        Each person who applies for renewal of a license as a certified pharmacy technician shall complete 10 hours of CE during the 12 months preceding the expiration date of the license, in accordance with Section 9.5 of the Act.

 

B)        A renewal applicant is not required to comply with CE requirements for the first renewal after original licensure.

 

2)         Required Topics for CE

 

A)        At least one hour of continuing pharmacy education must be on the subject of pharmacy laws, pharmacy rules and ethics;

 

B)        At least one hour of continuing pharmacy education must be on the subject of patient safety; and

 

C)        Any other applicable CE requirements under 68 Ill. Adm. Code 1130.

 

b)         Approved CE

 

1)         The completion of courses offered by providers approved by the Accreditation Council on Pharmacy Education or another standardized nationally approved education program approved by the Department, may be completed outside the State of Illinois are approved CE courses.

 

2)         The pharmacist-in-charge and the certified pharmacy technician must maintain records showing proof of training that constituted the pharmacy technician's CE.

 

c)         Certification of CE Requirements

 

1)         Each renewal applicant shall certify on the renewal application full compliance with CE requirements set forth in this Part.

 

2)         The Division may require additional evidence demonstrating compliance with the CE requirements (e.g., certificates of attendance, certificates of completion, course registration). It is the responsibility of each renewal applicant to retain or otherwise produce evidence of the compliance.  Evidence shall be required in the context of the Division's random audit in accordance with Section 9.5 of the Act.

 

d)         The same CE hours cannot be used to fulfill the CE requirement for more than one renewal period.

 

e)         Waiver of CE Requirements

 

1)         Any renewal applicant seeking to renew their license without having fully complied with these CE requirements shall file with the Division a renewal application, along with the required fee, a statement setting forth the facts concerning noncompliance and a request for waiver of the CE requirements with facts explaining the basis of the request. A request for waiver shall be made prior to the renewal date. If the Division, upon the written recommendation of the Board, finds from the affidavit or any other evidence submitted that good cause has been shown for granting a waiver, the Division shall waive enforcement of the CE requirements for the renewal period for which the applicant has applied.

 

2)         Good cause shall be defined as an inability to fulfill the CE requirements during the applicable period because of:

 

A)        Full-time service in the armed forces of the United States of America during the applicable period; or

 

B)        Extreme hardship, which shall be determined on an individual basis by the Board and shall be limited to documentation of:

 

i)          An incapacitating illness, documented by a currently licensed physician;

 

ii)         Physical inability to travel to the sites of approved programs, as documented by a currently licensed physician; or

 

iii)        Any other similar extenuating circumstances (e.g., illness of a family member).

 

3)         If a renewal applicant requests an interview before the Board at the time the waiver request is submitted, the Board shall not deny the waiver request before an interview is conducted.  The renewal applicant requesting a waiver shall be given at least 20 days written notice of the date, time, and place of the interview by mail or email.

 

4)         Any renewal applicant who submits a request for waiver pursuant to subsection (e)(1) shall be deemed to be in good standing until the final Division decision on the application has been made.

 

(Source:  Added at 47 Ill. Reg. 8352, effective June 2, 2023)

SUBPART C: PHARMACIST

 

Section 1330.300  Approval of Pharmacy Programs

 

a)         The Division shall, upon the recommendation of the Board, approve a pharmacy program in a school or college or department of pharmacy of a university or other institution as reputable and in good standing if it meets the following minimum criteria:

 

1)         Is legally recognized and authorized, through appropriate agencies such as a ministry of education or higher education governing board, by the jurisdiction in which it is located to confer a first professional degree in pharmacy;

 

2)         Has a faculty comprised of a sufficient number of full-time instructors to make certain that the educational obligations to the student are fulfilled.  Their facility must have demonstrated competence in their area of teaching as evidenced by appropriate degrees from professional colleges or institutions in disciplines reflective of the curricular requirements.  (All of the pharmacist members of the clinical faculty and a majority of the faculty in the pharmaceutical sciences should be licensed pharmacists in that jurisdiction.  The clinical faculty should be active practitioners.);

 

3)         Has a curricular offering of post-secondary instruction totaling at least 5 academic years, including any preprofessional education requirements, and requiring a minimum of the following subject areas:

 

A)        General Education (a minimum of 30 semester hours or its equivalent in courses in the humanities and behavioral and social sciences);

 

B)        Preclinical Sciences (courses in the physical and biological sciences and mathematics that are prerequisites to professional studies and training; course work should include general chemistry, organic chemistry, general biology, microbiology and mathematics);

 

C)        Professional Studies and Training (in the following areas):

 

i)          Biomedical sciences, which include anatomy, physiology, immunology, biological chemistry, pathology and biostatistics;

 

ii)         Pharmaceutical sciences, which include pharmaceutical or medicinal chemistry, pharmaceutics or dosage form design and evaluation, pharmacokinetics, synthetic and natural drug product chemistry, pharmacology, pharmaceutical administration and the social and behavioral sciences in pharmacy;

 

iii)        Clinical sciences and practice, which include clinically applied courses based on the biomedical and pharmaceutical sciences, such as didactic courses in clinical foundations, disease processes and diagnoses, clinical pharmacology and therapeutics, and drug information research and literature retrieval; and

 

iv)        Externship and clerkship, which include a minimum of 400 direct contact hours in clerkship and externship experience.  These experiences should minimally include supervised training in inpatient environments providing for interdisciplinary experiences with other health professionals and distributive aspects of pharmacy practice;

 

4)         Has essential facilities including, but not limited to, administrative and faculty offices, teaching and research laboratories, lecture rooms, conference rooms, student activities areas, service areas and other programmatic support areas;

 

5)         Has a comprehensive library that contains a contemporary collection of periodicals, texts and reference books relevant to the biomedical, pharmaceutical and clinical aspects of health care and its systems of delivery;

 

6)         Has clinical facilities adequate in number and quality and with appropriate supervision to deliver the clinical clerkships and externships of the curriculum.  The facilities shall be available in inpatient and outpatient environments, including patient care areas of health care institutions, hospital pharmacies and community pharmacies; and

 

7)         Maintains permanent retrievable and auditable student records that summarize the credentials for admission, attendance, grades and other records of performance for each student enrolled in the program.

 

b)         In determining whether a school or college should be approved, the Division shall take into consideration, but not be bound by, accreditation standards established by the Accreditation Council on Pharmacy Education.

 

c)         An applicant from a pharmacy program that has not been evaluated shall cause to be forwarded to the Division documentation concerning the criteria in this Section.  If the documentation is insufficient to evaluate the program, the applicant will be required to provide such additional information as necessary.  Once the Division has received the documentation or after 6 months have elapsed from the date of application, whichever is first, the Board will evaluate the program based on all documentation received from the school and any additional information the Division has received that will enable the Board to evaluate the program based on the criteria specified in this Section.  In the event the program is not approved as reputable and in good standing by the Division, applicants from the program must successfully complete the preliminary diagnostic examination and all other requirements set forth in the Act and this Part.

 

d)         The Director shall, upon written recommendation of the Board, withdraw, suspend or place on probation the approval of a pharmacy program when the Director determines, based upon the report of the Board, the quality of the program has been materially affected.  In determining the existence of a material effect, the Board and the Director shall consider:

 

1)         Gross or repeated violations of any provision of the Act;

 

2)         Gross or repeated violations of any provision of this Part;

 

3)         Fraud or dishonesty in furnishing documentation for evaluation of the pharmacy program; or

 

4)         Failure to continue to meet the established criteria for an approved pharmacy program set out in this Section.

 

e)         When approval of a pharmacy program is being reconsidered by the Division, written notice shall be given at least 15 days prior to any recommendation by the Board, and the officials in charge may either submit written comments or request an interview before the Board.

 

f)         The Division, upon the recommendation of the Board, has determined that all pharmacy programs accredited by the Accreditation Council on Pharmacy Education as of July 1, 2007 meet the minimum criteria set forth in subsection (a) and are, therefore, approved.  The Board shall review the list of accredited programs published each year on July 1 by the Accreditation Council on Pharmacy Education in order to determine whether the programs continue to meet the minimum criteria.

 

Section 1330.310  Graduates of Programs Outside the United States

 

Applicants who are graduates of a first professional degree program in pharmacy located outside the United States or its territories that is not approved pursuant to the provisions of Section 1330.300 shall submit proof of:

 

a)         Submission of a Foreign Pharmacy Graduate Examination Committee (FPGEC) Certificate;

 

b)         Passage of the preliminary diagnostic examination (Foreign Pharmacy Graduate Equivalency Exam (FPGEE)) designed to determine equivalence of education to programs approved pursuant to Section 1330.300;

 

c)         The minimum acceptable scores are 550 for the paper TOEFL and 50 for the paper TSE, or 213 for the computer-based TOEFL and TSE combination, or 88 for the Internet-based TOEFL iBT with a minimum score of 26 on the speaking module;

 

d)         Passage of the Test of Spoken English (TSE) examination with a score of 50; and

 

e)         Either:

 

1)         Completion of a course of clinical instruction totaling 1,200 clinical hours approved by the Board as required by Section 7 of the Act.  The course of clinical instruction shall be conducted under the supervision of a pharmacist registered in the State of Illinois.  The applicant shall obtain prior approval of the Board before enrolling in the course of clinical instruction.  In approving a course of clinical instruction, the Board shall consider, but not be limited to, whether the course:

 

A)        Enhances development of effective communication skills by enabling consultation among the applicant, the prescriber and the patient;

 

B)        Promotes development of medical data retrieval skills through exposure to patient medical charts, patient medication profiles and other similar sources of patient information;

 

C)        Promotes development of the applicant's ability to research and analyze drug information literature; and

 

D)        Promotes development of the applicant's ability to interpret laboratory test and physical examination results; or

 

2)         Have been licensed in a U.S. jurisdiction or territory for at least 1 year with no disciplinary actions or encumbrances on their license or pending license.

 

Section 1330.320  Application for Examination

 

a)         An applicant for examination shall apply, on forms approved by the Division, at least 30 days prior to an examination date. The application shall include:

 

1)         One of the following:

 

A)        Certification of graduation from a first professional degree program in pharmacy.  The program must be approved by the Division upon recommendation of the Board of Pharmacy under the provisions of Section 1330.300; or

 

B)        Certification, in the case of an applicant applying in the last half-year of the curriculum, from the dean of an approved pharmacy program indicating the applicant is expected to graduate.  It is the responsibility of the individual school to notify the Division of all the students who do not graduate; or

 

C)        Proof of compliance with Section 1330.310 if the applicant is a graduate of a program located outside the United States; and

 

2)         The fee required by Section 1330.20.

 

b)         An applicant whose application is complete shall be scheduled for the next available examination.

 

c)         If the applicant has successfully completed in another jurisdiction the examinations required by Section 1330.330(a)(1) and (2)(B), the applicant may have examination scores submitted to the Division from the reporting entity.

 

Section 1330.330  Examination for Licensure

 

a)         The examination for licensure as a registered pharmacist shall be divided into two portions:

 

1)         Theoretical and Applied Pharmaceutical Sciences portion, which shall test the following subjects:

 

A)        Medicinal Chemistry;

 

B)        Pharmacology;

 

C)        Pharmacy;

 

D)        Pharmaceutical Calculations;

 

E)        Interpreting and Dispensing Prescription Orders;

 

F)         Compounding Prescription Orders; and

 

G)        Monitoring Drug Therapy; and

 

2)         Pharmaceutical Jurisprudence portion, which consists of 2 parts and shall test:

 

A)        Illinois law related to pharmacy practice; and

 

B)        Federal law related to pharmacy practice.

 

b)         An applicant must score a minimum of 75 on the Theoretical and Applied Pharmaceutical Sciences portion and a minimum of 75 on the combined Pharmaceutical Jurisprudence portion in order to successfully pass the examination for licensure.  An applicant who scores 75 or greater in either the Theoretical and Applied Pharmaceutical Sciences portion or on either of the combined Pharmaceutical Jurisprudence portions will not be required to retake that portion of the examination.  The reporting of scores to the candidates shall include the score obtained on the Theoretical and Applied Pharmaceutical Sciences, the score obtained on the Federal Law portion, a pass or fail score on the Illinois Law portion and the combined score consisting of the Federal Law portion and the State Law portion.

 

c)         Any applicant who fails the NAPLEX portion three times or the MPJE portion of the registered pharmacist examination three times in any jurisdiction will be required to furnish proof of remedial education in an approved program on the subjects of the portion failed.  Proof of additional remedial education in an approved program shall also be furnished each time the applicant fails each portion of the examination three times after undergoing remedial education (i.e., after the sixth exam, ninth exam, etc.).

 

d)         For the purposes of this Section remedial training shall be defined as:

 

1)         A course of study of at least 30 classroom hours in an approved pharmacy college in the subjects of the portions failed three times; or

 

2)         A tutorial or preceptorship with a faculty member in an approved pharmacy college or another pharmacist as a preceptor.  The course of instruction must be deemed by the Board to be substantially equivalent to subsection (e)(1) and approved by the Division.  Any remedial training must be approved by the Board and the Division prior to commencement.

 

e)         The provisions of this Section shall apply to all applicants upon adoption without regard to where the applicant is in the application process.

 

(Source:  Amended at 48 Ill. Reg. 10225, effective June 28, 2024)

 

Section 1330.340  Application for Licensure on the Basis of Examination

 

a)         An applicant for licensure on the basis of examination shall submit to the Division a properly completed application on forms provided by the Division, along with the following:

 

1)         The fee required by Section 1330.20;

 

2)         Certification of graduation from an approved program of pharmacy (see Section 1330.300); and

 

3)         Proof of successful completion of the examination approved by the Division (see Section 1330.330).

 

b)         Upon receipt of the items required in subsection (a), and upon verification by the Division that the candidate meets all of the requirements for licensure as a Registered Pharmacist, the Division shall issue a license to practice pharmacy or notify the applicant of the reason for denial.

 

Section 1330.350  Endorsement

 

a)         An applicant who is currently licensed by examination under the laws of another U.S. jurisdiction or another country shall file an application with the Division, together with:

 

1)         Certification of graduation from a pharmacy program approved pursuant to Section 6 of the Act and Section 1330.300 of this Part;

 

2)         For individuals licensed in another state prior to January 1, 1983, proof of having completed the hours of apprenticeship, or, if at least 1500 hours of apprenticeship were not required, an affidavit attesting to the period of the applicant's active experience as a pharmacist;

 

3)         A certification by the state or territory of original licensure stating:

 

A)        The time during which the applicant was licensed in that state;

 

B)        Whether the file on the applicant contains any record of any disciplinary actions taken or pending; and

 

C)        A brief description of the examination and the applicant's grades;

 

4)         Proof of successful passage of the Illinois multi-state jurisprudence examination; and

 

5)         The fee as required by Section 1330.20.

 

b)         The Division shall examine each application to determine whether the requirements, at the time of licensure in the state where the applicant was licensed by examination, were substantially equivalent to the requirements then in force in this State.

 

c)         If the requirements are found to be substantially equivalent and the applicant graduated from an approved college of pharmacy and meets all other requirements of the Act, the Division will notify the applicant of approval and/or denial and the reasons for the approval or denial within 30 days after receipt of the application and supporting documentation.

 

Section 1330.360  Pharmacy Residents

 

A pharmacy resident participating in a nationally accredited residency program is exempt from Section 15.1(a) of the Act to the extent the provision conflicts with the requirements of the nationally accredited residency program.

 

(Source:  Added at 47 Ill. Reg. 8352, effective June 2, 2023)

SUBPART D: PHARMACY LICENSURE

 

Section 1330.400  Application for a Pharmacy License

 

a)         Establishing, Relocating or Changing Ownership

 

1)         Any person who desires to establish, relocate or change the ownership of a pharmacy shall file an application on forms supplied by the Division, together with the fee required by Section 1330.20, and specify the types of pharmacy services to be provided as described in Sections 1330.500, 1330.510, 1330.520, 1330.530, 1330.540, 1330.550 and 1330.560.

 

2)         Upon determination that the application is in good order, an inspection of the premises will be conducted to determine compliance with Sections 1330.610, 1330.620, 1330.630, 1330.640 and 1330.680.  An application shall be in good order when it is signed and notarized and the license of the pharmacist-in-charge has been verified to be in good standing with the Division.

 

3)         Upon recommendation of the Drug Compliance Coordinator, the Board may request the owner of the pharmacy and the pharmacist-in-charge to appear for an interview with the Board.

 

b)         For a change of name of pharmacist-in-charge only, the owner shall be required to file an application on forms supplied by the Division, together with the required fee, and submit the present license.  The Division shall evaluate the application and, if satisfactory, issue a new license.

 

c)         Within 180 days after issuance of a pharmacy license, the pharmacy for which the licensure was requested shall be open to the public for pharmaceutical services.

 

d)         Any reduction in hours of operation shall be reported to the Division within 30 days after the reduction in hours take effect.

 

e)         Upon receipt by the Division of a change of ownership application, the purchaser may begin operations prior to the issuance of a new pharmacy license only when the purchaser and seller have a written power of attorney agreement. This agreement shall provide, among other things, that violations during the pendency of the application process shall be the sole responsibility of the seller. This agreement shall be provided to the Division upon request.

 

f)         No pharmacy shall relocate prior to the inspection of the premises. All drugs shall be transferred within 24 hours after issuance of the license unless otherwise approved by the Department.

 

(Source:  Amended at 48 Ill. Reg. 10225, effective June 28, 2024)

 

Section 1330.410  Pharmacy Licenses

 

a)         Each individual, partnership, corporation or any other applicant for a pharmacy license shall indicate, on forms supplied by the Division, the type of pharmacy services to be provided by the licensee.

 

b)         The Board may review and make recommendations to the Director regarding pharmacy applications filed with the Division.

 

c)         A pharmacy who provides more than one type of pharmacy service shall be issued one pharmacy license and shall be charged the appropriate fee, as set forth in Section 1330.20.

 

d)         A pharmacy shall designate a pharmacist-in-charge as provided for in Section 1330.660.

 

e)         When a third-party company is hired to run a pharmacy, that third-party company shall be the license holder; however, the license may be issued with the name of the pharmacy, as a d/b/a, or with the name of the third-party company.  The Illinois Controlled Substance license shall be issued to the third-party company unless the third-party company and the pharmacy or hospital cosigns a pharmacy service agreement that assigns overall responsibility for controlled substances to the hospital or pharmacy.

 

(Source:  Amended at 48 Ill. Reg. 10225, effective June 28, 2024)

 

Section 1330.420  Emergency Remote Temporary Pharmacy License

 

a)         Definitions:

 

1)         "Emergency remote temporary pharmacy" means a pharmacy not located at the same location as a home pharmacy at which pharmacy services are provided during an emergency situation.

 

2)         "Emergency situation" means an emergency caused by a natural or manmade disaster or any other exceptional situation that causes an extraordinary demand for pharmacy services.

 

b)         The following is applicable for the emergency remote temporary pharmacy:

 

1)         The emergency remote temporary pharmacy will not be issued a separate pharmacy license but shall operate under the license of the home pharmacy.  To qualify for an emergency remote temporary pharmacy license, the applicant must submit an application including the following information:

 

A)        license number, name, address and phone number of the home pharmacy;

 

B)        names, address and phone number of the emergency remote temporary pharmacy;

 

C)        name and pharmacist license number of the pharmacist-in-charge of the home pharmacy and of the pharmacist-in-charge of the emergency remote temporary pharmacy; and

 

D)        any other information required by the Board.

 

2)         The Division will notify the home pharmacy of the approval of an emergency remote temporary pharmacy license.

 

3)         The emergency remote temporary pharmacy license shall be valid for a period determined by the Director not to exceed 6 months.  The Director, in his or her discretion, may renew the emergency remote temporary pharmacy license for an additional 6 months if the emergency situation still exists and the holder of the license shows good cause for the emergency remote temporary pharmacy to continue operation.

 

4)         The emergency remote temporary pharmacy shall have a written contract or agreement with the home pharmacy that outlines the services to be provided and the responsibilities and accountabilities of the remote and home pharmacy in fulfilling the terms of the contract or agreement in compliance with federal and State laws and regulations.

 

5)         The home pharmacy shall designate a pharmacist to serve as the pharmacist-in-charge of the emergency remote temporary pharmacy.

 

6)         The equipment and facility of the pharmacy must enable prescriptions to be filled accurately and properly compounded; it must be operated and maintained in a manner that will not endanger the health and safety of the public. 

 

7)         An onsite pharmacy can only provide service to patients, staff or families of staff of that institution.

SUBPART E: TYPES OF PHARMACIES

 

Section 1330.500  Community Pharmacy Services

 

a)         Pharmacies that engage in general or specialty community pharmacy practice and are open to, or offer pharmacy service to, the general public shall, in addition to any other requirements of the Act and this Part, comply with this Section.  A community pharmacy that, in addition to offering pharmacy services to the general public, provides institutional services shall also comply with Section 1330.520.

 

b)         Staffing of the Pharmacy

 

1)         Whenever the hours of the pharmacy differ from those of the establishment in which the pharmacy is located, the schedule during which pharmacy services are provided shall be conspicuously displayed.

 

2)         Whenever a pharmacy is open and a pharmacist is not present and available to provide pharmacy services, a sign stating that situation shall be conspicuously displayed.

 

3)         No prescription may be dispensed when a pharmacist is not physically present in the establishment.

 

c)         Recordkeeping Requirements for Dispensing Prescription Drugs

 

1)         For every prescription dispensed, the prescription record shall contain the name, initials or other unique identifier of the pharmacist who dispenses the prescription drugs.  No prescription may be dispensed after 15 months from the date of the original issuance of the prescription by the prescriber.

 

2)         Whenever a prescription is dispensed by a registered pharmacy technician or certified pharmacy technician under the supervision of a pharmacist, the prescription record shall contain the names, initials or other unique identifier of both the supervising pharmacist and the registered pharmacy technician or certified pharmacy technician who dispenses the prescription. 

 

3)         Refilling a Prescription

 

A)        Each refilling of a prescription shall be entered on the prescription or on another appropriate, uniformly maintained, readily retrievable record that indicates, by the number of the prescription, the following information:

 

i)          The name and dosage form of the drug;

 

ii)         The date of each refilling;

 

iii)        The quantity dispensed;

 

iv)        The name or initials of the pharmacist and the pharmacy technician, if applicable, in each refilling; and

 

v)         The total number of refills remaining for the prescription.

 

B)        If the pharmacist does not otherwise indicate in a uniformly maintained record, the pharmacist shall be deemed to have dispensed a refill for the full face amount of the prescription.

 

4)         Presentation of a written prescription copy or prescription label shall be for information purposes only and has no legal status as a valid prescription order.  The recipient pharmacist of the copy or prescription label shall contact the prescribing practitioner to obtain a new prescription order.

 

5)         Copies of prescriptions given to an ultimate consumer shall be marked "For Information Purposes Only".

 

6)         Subject to Section 18 of the Act, any information required to be kept pursuant to that Section may be recorded and stored in a computerized pharmaceutical information system that meets the standards of performance stated in the regulations of the Drug Enforcement Administration (21 CFR 1306; 2014), except as provided in subsection (c)(7), and shall include the capability to:

 

A)        Retrieve the original prescription order information for those prescription orders currently authorized for refilling;

 

B)        Retrieve the current prescription orders, including, at a minimum, name of drug, date of refill, quantity dispensed, name and identification code of the manufacturer in the case of a generically written prescription or a generic interchange, name or initials of the dispensing pharmacist and technician for each refill, and the total number of refills dispensed to date;

 

C)        Supply documentation of refill information entered by the pharmacist using the system through a hard copy printout of each day's refill data that has been verified for correctness. This printout must include for each prescription filled at least the following information:

 

i)          The name and dosage form of the drug;

 

ii)         The date of each refilling;

 

iii)        The quantity dispensed;

 

iv)        The name or initials of the pharmacist in each refilling and the pharmacy technician, if applicable;

 

v)         The patient's name;

 

vi)        The prescriber's name; and

 

vii)       The prescription number for the prescription.

 

7)         In lieu of the printout required by subsection (c)(6), the pharmacy shall maintain a bound log book, or separate file, in which each individual pharmacist involved in the dispensing shall sign a statement each day, attesting to the fact that the refill information entered into the computer that day has been reviewed and is correct as shown.  The book or file must be maintained at the pharmacy employing the system for a period of 5 years after the date of dispensing the appropriately authorized refill.

 

8)         All refill data shall be maintained by the pharmacy on the premises for 5 years, in accordance with Section 18 of the Act.  The pharmacy shall have the appropriate equipment on the premises to provide readily retrievable information in the course of an on-site inspection.  A hard copy printout shall be provided to the Division, upon request, within 48 hours.

 

d)         Any drug that is dispensed pursuant to prescription, other than vaccinations administered in the pharmacy, shall have affixed to its container a label as provided in Section 22 of the Act.

 

e)         No person shall establish or move to a new location any pharmacy unless the pharmacy is licensed with the Division and has on file with the Division a verified statement that:

 

1)         The pharmacy is or will be engaged in the practice of pharmacy; and

 

2)         The pharmacy will have in stock and will maintain sufficient prescription drugs and materials to protect the public it serves within 30 days after opening of the pharmacy.

 

f)         Pharmacies have a duty to deliver lawfully prescribed drugs to patients and to distribute nonprescription drugs approved by the U.S. Food and Drug Administration for restricted distribution by pharmacies, or to substitute a generic drug as permitted in Section 25 of the Act in a timely manner, or to contact the prescriber to obtain authorization to dispense a different drug that produces a similar clinical effect in a timely manner, except for the following or substantially similar circumstances:

 

1)         When, in the pharmacist's professional judgment, after screening for potential drug therapy problems due to therapeutic duplication, drug-disease contraindications, drug-drug interactions (including, but not limited to, serious interactions with nonprescription or over-the-counter drugs), drug-food interactions, incorrect drug dosage or duration of drug treatment, drug-allergy interactions, or clinical abuse or misuse, pursuant to Section 3(aa) of the Act, the pharmacist determines that the drug should not be dispensed due to one of the foregoing clinical reasons;

 

2)         National or State emergencies or guidelines affecting availability, usage or supplies of drugs;

 

3)         Lack of specialized equipment or expertise needed to safely produce, store or dispense drugs, such as certain drug compounding or storage for nuclear medicine;

 

4)         Potentially fraudulent prescriptions;

 

5)         Unavailability of drug; or

 

6)         The drug is not typically carried in similar practice settings in the State.

 

g)         Nothing in this Section requires pharmacies to dispense a drug without payment of their usual and customary or contracted charge.

 

h)         All pharmacies shall be required to maintain the following current resource materials, either in hard copy or electronic format:

 

1)         Copies of the Act and this Part;

 

2)         Illinois Controlled Substances Act and 77 Ill. Adm. Code 3100;

 

3)         Title 21 of the United States Code of Federal Regulations (Food and Drugs); and

 

4)         Hypodermic Syringes and Needles Act [720 ILCS 635].

 

i)          If the lawfully prescribed drug or nonprescription drug approved by the U.S. Food and Drug Administration for restricted distribution by pharmacies is not in stock or is otherwise unavailable, or the prescription cannot be filled pursuant to subsection (f)(1) or (f)(6), the pharmacy shall provide the patient or agent a timely alternative for appropriate therapy that, consistent with customary pharmacy practice, may include obtaining the drug. These alternatives include but are not limited to:

 

1)         Contact the prescriber to address concerns such as those identified in subsection (f)(1);

 

2)         If requested by the patient or the patient's agent, return unfilled lawful prescriptions to the patient or agent; or

 

3)         If requested by the patient or the patient's agent, communicate or transmit, as permitted by law, the original prescription information to a pharmacy of the patient's choice that will fill the prescription in a timely manner.

 

j)          Any mail order pharmacy that provides services in Illinois shall provide, during its regular hours of operation, but not less than 6 days per week for a minimum of 40 hours per week, a toll-free telephone service to facilitate communication between patients in this State and a pharmacist retained by the mail order pharmacy who has access to the patient's records. The toll free number must be disclosed on the label affixed to each container of drugs dispensed to residents of the State. 

 

k)         Engaging in or permitting any of the following shall constitute grounds for discipline or other enforcement actions:

 

1)         Intentionally destroying unfilled lawful prescriptions;

 

2)         Refusing to return unfilled lawful prescriptions;

 

3)         Violating a patient's privacy;

 

4)         Discriminating against patients or their agents in a manner prohibited by State or federal laws;

 

5)         Intimidating or harassing a patient; or

 

6)         Failing to comply with the requirements of this Section.

 

(Source:  Amended at 47 Ill. Reg. 8352, effective June 2, 2023)

 

Section 1330.510  Telepharmacy

 

a)         Telepharmacy shall be limited to the types of operations described in this Section.  Each site where such operations occur shall be a separately licensed pharmacy. Home pharmacies that are located outside of Illinois must be licensed as a nonresident pharmacy. Nonresident pharmacies shall abide by all Illinois laws and rules when filling prescriptions for Illinois residents, except that the dispensing pharmacist and the pharmacist-in-charge shall not be required to be licensed in Illinois, except as otherwise provided in this Part.

 

b)         Remote Dispensing Site

 

1)         Written prescriptions presented to the remote dispensing site shall be scanned into the electronic data processing equipment to ensure initial dispensing and each refill and the original prescription may be viewed on the monitor at both the remote dispensing site and home pharmacy site.  Records shall be maintained at the remote dispensing site.

 

2)         A remote site is considered to be under the supervision of the pharmacist-in-charge of the home pharmacy. Each home pharmacy may supervise no more than 3 remote sites that are simultaneously open.

 

3)         The remote site shall use its home pharmacy and pharmacy management system.

 

A)        The system shall assign consecutive prescription numbers.

 

B)        Prescriptions dispensed at the remote site shall be distinguishable from those dispensed from the home pharmacy.

 

C)        Daily reports must be separated for the home and remote site.

 

4)         A pharmacist at the home pharmacy must verify each prescription before it leaves the remote site.

 

A)        Pharmacist and pharmacy technician initials or unique identifiers must appear on the prescription record and the prescription label.

 

B)        A pharmacist shall electronically compare via video link the stock bottle, drug dispensed, the strength and its beyond use date.  The entire label must be checked for accuracy on the video link.

 

C)        The remote dispensing site shall utilize a barcode system that prints the barcode of the stock bottle on the label of the dispensed drug. If the stock bottle does not have a barcode, the pharmacy shall create one.  The technician shall scan both the stock bottle and the label of the dispensed drug to verify that the drug dispensed is the same as the drug in the stock bottle for each prescription dispensed.

 

D)        A pharmacy may utilize a different electronic verification system that accomplishes the same purpose after review and approval of the Division.

 

5)         Counseling must be done by a pharmacist via video link and audio link.  Pursuant to Section 1330.700, the pharmacist providing counseling, pursuant to this subsection, must be employed or contracted by the home pharmacy or by a pharmacy contracted with the home pharmacy and have access to all relevant patient information maintained by the home pharmacy.

 

6)         A pharmacist-in-charge or a designated pharmacist must complete monthly inspections of the remote site.  Inspection criteria must be included in the policies and procedures for the site.  The inspection report must be available on site for pharmacy investigator inspection.

 

7)         Controlled substances shall be kept at the remote site in accordance with the Act and this Part.  All records must be stored at the remote site.

 

8)         There shall be a working computer link, video link and audio link to a pharmacist at a home pharmacy whenever the prescription area is open to the public.  The communication link must be checked daily and the remote site pharmacy must be closed if the link malfunctions, unless a pharmacist is physically present at the remote site.

 

A)        The pharmacy technician located at the remote dispensing site must have one year of experience and be registered as a certified pharmacy technician, or be a student pharmacist.

 

B)        New prescriptions received at the remote dispensing site may be entered into the remote computer system with all verification, interaction, checking and profile review by the pharmacist at the home pharmacy.

 

C)        Each pharmacist at the home pharmacy may electronically supervise no more than 3 remote sites that are simultaneously open.

 

9)         The facility must have a sign clearly identifying it as a remote dispensing site.

 

10)         The facility shall have an area for patient consultation, exclusive of any waiting area.

 

c)         Remote Consultation Site

 

1)         These sites have no prescription inventory.

 

2)         Only filled prescriptions, filled at the home pharmacy, with final patient labeling attached are allowed at these sites.

 

3)         These sites must be staffed with a pharmacy technician or certified pharmacy technician who has the knowledge necessary to use computer audio/video link for dispensing and consultation to occur.  Pharmacist and pharmacy technician initials or unique identifiers must appear on the prescription record and the prescription label.

 

4)         Written prescriptions may be received at a remote consultation site.  All written prescriptions presented at a remote consultation site shall be delivered to the home pharmacy within 72 hours.

 

5)         Security of filled prescriptions must be maintained by storing them in a separate lock drawer or cabinet.

 

6)         Recordkeeping shall be conducted by the pharmacist (time/date) when dispensing and counseling occurred.

 

7)         The site shall have a room for patient consultation exclusive of any waiting area.

 

8)         The site must have a sign clearly identifying it as a remote consultation site.

 

d)         Automated Pharmacy Systems (Section 22(b) of the Act)

 

1)         Remote Automated Pharmacy Systems (RAPS)

 

A)        These devices shall maintain a prescription drug inventory that is controlled electronically by the home pharmacy or, when operated by a pharmacy contracted with the home pharmacy, by the contracted pharmacy, which shall be utilized to dispense patient specific prescriptions.

 

B)        These systems shall have prescription inventory, which must be secured in an automated pharmacy system and electronically connected to and controlled by the home pharmacy.

 

C)        A pharmacist must approve all the prescription orders before they are released from the RAPS.

 

D)        Dispensing and counseling are performed by a pharmacist employed or contracted by the home pharmacy via audio and video link.

 

E)        All filled prescriptions must have a label that meets the requirements of the Act attached to the final drug container.

 

F)         The pharmacist-in-charge of the home pharmacy, or a designated registrant, shall conduct and complete monthly inspections of the RAPS.  Inspection criteria must be included in the policies and procedures for the site.  The report must be available to the pharmacy investigators when requested.

 

G)        The RAPS must be licensed with the Division as an automated pharmacy system and will be subject to random inspection by pharmacy investigators.  Notwithstanding that the RAPS shall possess a license, the home pharmacy shall remain responsible for inventory control and billing.  For purposes of random inspections, a pharmacist with access to the system must be available at the site within one hour, or as otherwise approved by the drug compliance investigator. In the event the Department's Chief Pharmacy Coordinator determines that the RAPS poses a significant risk of patient harm, the RAPS must be disabled until such time as the pharmacist with access to the system is available to the site.

 

H)        Medication dispensed at the automated pharmacy system site may only be packaged by a licensed manufacturer or repackager, or prepackaged by a licensed pharmacy in compliance with this Section.  Prepackaging must occur at the home pharmacy, a pharmacy sharing common ownership with the home pharmacy, or a pharmacy that has contracted with the home pharmacy to perform prepackaging services.  The following requirements shall apply whenever medications are prepackaged by a pharmacy other than the home pharmacy:

 

i)          The prepackaging pharmacy shall be licensed in Illinois as a resident or nonresident pharmacy.

 

ii)         The prepackaging pharmacy shall share a common database with the home pharmacy, or have in place an electronic or manual process to ensure that both pharmacies have access to records to verify the identity, lot numbers and expiration dates of the prepackaged medications stocked in the RAPS.

 

iii)        The prepackaging pharmacy shall maintain appropriate records to identify the responsible pharmacist who verified the accuracy of the prepackaged medication.

 

I)         Written prescriptions may be received at a RAPS. All written prescriptions presented to a RAPS shall be scanned utilizing imaging technology that permits the reviewing pharmacist to determine its authenticity. The sufficiency of the technology shall be determined by the Department.  If sufficient technology is not used, the written prescriptions must be delivered to the home pharmacy and reviewed by a pharmacist prior to being dispensed to the patient.

 

2)         Kiosk

 

A)        A kiosk is a device that maintains individual patient prescription drugs that were verified and labeled at the home pharmacy.

 

B)        A home pharmacy may only use the kiosk with prior approval of a patient.

 

C)        A kiosk located on the same premises or campus of the home pharmacy shall operate under the same license as the home pharmacy.  However, a kiosk must be licensed with the Division if it is not so located.

 

D)        A kiosk shall:

 

i)          When located on the same premises or campus as the pharmacy, inform a patient, if using the device when the pharmacy is open, that the patient may address questions and concerns regarding the prescription to a pharmacist at the pharmacy;

 

ii)         When not located on the same premises or campus as the pharmacy, inform a patient, if using the device when the pharmacy is closed, that he or she may immediately direct any questions and concerns regarding the prescription to a licensed pharmacist via a pharmacy provided audio/video link;

 

iii)        Inform a patient that a prescription is not available to be delivered by the device if the pharmacist desires to counsel the patient in person regarding the prescription.

 

3)         A pharmacy may use an automated pharmacy system to deliver prescriptions to a patient when the device:

 

A)        Is secured against a wall or floor;

 

B)        Provides a method to identify the patient and delivers the prescription only to that patient or the patient's authorized agent;

 

C)        Has adequate security systems and procedures to prevent unauthorized access, to comply with federal and State regulations, and to maintain patient confidentiality;

 

D)        Records the time and date that the patient removed the prescription from the system.

 

4)         A licensed automated pharmacy system shall not be utilized by prescribers. Nothing in this Section shall prevent a prescriber from utilizing an automated pharmacy system in connection with his or her own dispensing.  However, a prescriber may not utilize or access an automated pharmacy system licensed pursuant to this Section.

 

e)         All pharmacists performing services in support of a remote dispensing site, remote consultation site, kiosk, or RAPS must display a copy or electronic image of their licenses at the remote site where they provide services, or shall otherwise make their license visible to the patient, and be licensed in this State, unless employed by a pharmacy licensed in Illinois as a nonresident pharmacy, in which case, the pharmacist providing the services shall hold an active license as a pharmacist in the state in which the nonresident pharmacy is located and only the pharmacist-in-charge of the remote site must be licensed in Illinois.

 

f)         Each remote site must display a sign, easily viewable by the customer, that states:

 

1)         The facility is a telepharmacy supervised by a pharmacist located at (address); and

 

2)         The pharmacist is required to talk to you, over an audio/visual link, each time you pick up a prescription.

 

g)         No remote site may be open when the home pharmacy is closed, unless a pharmacist employed or contracted by the home pharmacy, or by a pharmacy contracted with the home pharmacy, is present at the remote site or is remotely providing supervision and consultation as required under this Section.

 

(Source:  Amended at 47 Ill. Reg. 8352, effective June 2, 2023)

 

Section 1330.520  Offsite Institutional Pharmacy Services

 

a)         Pharmacies that are not located in the facilities they serve and whose primary purpose is to provide services to patients or residents of facilities licensed under the Nursing Home Care Act, the Hospital Licensing Act, the University of Illinois Hospital Act, or the Illinois Department of Human Services shall, in addition to any other requirements of the Act and this Part, comply with this Section.

 

b)         Recordkeeping Requirements for Dispensing Prescriptions or Orders

 

1)         Every prescription or order dispensed shall be documented with the name, initials or other unique identifiers of the pharmacist (and student pharmacist or pharmacy technician if one is used) authorized to practice pharmacy under the provisions of the Act who dispenses the prescription or order.  For purposes of the Act, an authorized person is:

 

A)        A pharmacist licensed in the State of Illinois; or

 

B)        A pharmacy technician, certified pharmacy technician or student pharmacist under the supervision of a pharmacist.

 

2)         Each pharmacy must maintain records for 5 years that contains the information in subsection (b)(3).  This information shall be readily retrievable and in a format that provides enforcement agents a concise, accurate and comprehensive method of monitoring drug distribution via an audit trail.  This system may require 2 or more documents that, when read together, will provide all the information required by federal (e.g., the regulations of the Drug Enforcement Administration (21 CFR 1300; 2014)) and State (e.g., the Pharmacy Practice Act and the Illinois Controlled Substances Act [720 ILCS 570]) statute.

 

3)         In addition to the recordkeeping requirements of subsection (b)(2), a uniformly maintained, readily retrievable hard copy record or back-up documentation of each prescription or order dispensed shall be maintained by the pharmacy for 5 years and shall include:

 

A)        Name of resident;

 

B)        Date of order;

 

C)        Name, strength and dosage form of drug, or description of the medical device ordered;

 

D)        Quantity dispensed (a separate record should be maintained when the quantity billed differs from the quantity dispensed, e.g., unit dose transfer systems);

 

E)        Directions for use;

 

F)         Quantity billed;

 

G)        Prescriber's name;

 

H)        Prescriber's signature and/or DEA number when required for controlled substances; and

 

I)         The drug name and identification code or the manufacturer in case of a generically ordered medication or a generic interchange.

 

4)         No prescription may be filled or refilled for a period in excess of 15 months from the date of the original issuance of the prescription or order by the prescriber.

 

5)         Subject to Section 18 of the Act, any information required to be kept pursuant to this Section may be recorded and stored in a:

 

A)        computerized pharmaceutical information system that meets the standards of performance required by the regulations of the Drug Enforcement Administration (21 CFR 1306; 2014) and shall include the capability to:

 

i)          Retrieve the original medication order information for those medication orders that are currently authorized;

 

ii)         Retrieve the current history of medication orders that shall, at a minimum, include the name of drug, the date of filling, the quantity dispensed, the name and identification code of manufacturer in the case of a generically written prescription or a generic interchange, for each filling, and the total number of refills when read in conjunction with any off-line hard copy of the history of medication orders dispensed to date; and

 

iii)        Supply documentation of the correctness of filling information entered into a system must be provided by the pharmacist using the system by way of a hard copy printout of each day's filling data that has been verified, dated and signed by the dispensing pharmacist; or

 

B)        bound logbook, or separate file, in which each individual pharmacist involved in dispensing shall sign a statement each day attesting to the fact that the refill information entered into the computer that day has been reviewed by the individual pharmacist and is correct as shown.  The book or file must be maintained at the pharmacy employing the system for a period of 5 years after the date of dispensing the appropriately authorized refill.

 

c)         In the event the long-term care facility changes pharmacy provider services, their new provider must obtain the orders from the long-term care facility and verify the authenticity and accuracy of the orders with the prescriber.

 

d)         Staffing of the Pharmacy.  When the pharmacy is closed, the public and any employees not registered under the Act are to be prohibited access to the filling and dispensing area.

 

e)         Labeling Requirements

 

1)         Medications for Future Use

 

A)        Parenteral solutions to which a drug or diluent has been added or that are not in their original manufacturer's packaging shall contain the following information on the outer label:

 

i)          Name, concentration and volume of the base parenteral solution;

 

ii)         Name and strength of drugs added;

 

iii)        Beyond use date and date of the admixture. Beyond use date, unless otherwise specified in the individual compendia monograph shall be not later than the beyond use date on the manufacturer's container or one year from the date the drug is repackaged, whichever is earlier; and

 

iv)        Reference code to identify source and lot number of drugs added.

 

B)        Non-parenterals repackaged for future use shall be identified with the following information:

 

i)          Brand and/or generic name;

 

ii)         Strength (if applicable);

 

iii)        Beyond use date.  Unless otherwise specified in the individual monograph, the beyond use date shall be not later than the beyond use date on the manufacturer's container or one year from the date the drug is repackaged, whichever is earlier; and

 

iv)        Reference code to identify source and lot number.

 

2)         Medications Prepared for Immediate Use

 

A)        All medications prepared by the pharmacy for immediate dispensing to a specific resident or patient in the facility shall be dispensed in a container identified with:

 

i)          Name of the resident;

 

ii)         Resident's room and bed number;

 

iii)        Dispensing date;

 

iv)        Name, strength and dosage form of drug, or description of the medical device ordered;

 

v)         Quantity dispensed;

 

vi)        Directions for use;

 

vii)       Prescriber's name; and

 

viii)      Beyond use date if less than 60 days from date of dispensing.

 

B)        Pharmacies dispensing medications to a specific resident or patient in the facility via unit dose shall label each order with the following information:

 

i)          Name of the resident;

 

ii)         Resident's room and bed number;

 

iii)        Date of order;

 

iv)        Name, strength and dosage form of drug, or description of the medical device ordered;

 

v)         Directions for use; and

 

vi)        Prescriber's name.

 

f)         Pharmacies that compound and dispense sterile products shall comply with Section 1330.640.

 

g)         Medication Dispensing in the Absence of a Pharmacist. The availability of necessary medications for immediate therapeutic use during those hours when the institutional pharmacy is not open shall be met in the following manner:

 

1)         An after-hour cabinet, which is a locked cabinet or other enclosure located outside of the pharmacy area containing a minimal supply of the most frequently required medication, may be utilized provided that only personnel specifically authorized by the institution in which the pharmacy is located may obtain access and it is sufficiently secure to deny access to unauthorized persons. After-hour cabinets shall only be used in the absence of a pharmacist. When medication is removed from the cabinet or enclosure, written physician's orders authorizing the removal of the medication shall be placed in the cabinet or enclosure. A log shall be maintained within the cabinet or enclosure and authorized personnel removing medication shall indicate on the log the signature of the authorized personnel removing the medication, the name of the medication removed, the strength (if applicable), the quantity removed and the time of removal. An automated dispensing and storage system may be used as an after hours cabinet. This use shall be in compliance with Section 1330.680.

 

2)         Emergency kits containing those drugs that may be required to meet the immediate therapeutic needs of the patient, and that are not available from any other source in sufficient time to prevent risk of harm to patients by delay resulting from obtaining the drugs from the other source, may be utilized.  Emergency kits shall be supplied and maintained under the supervision of a pharmacist.  Drugs shall be removed from emergency kits only by authorized pharmacy personnel or persons authorized to administer medication pursuant to a valid  order by a practitioner licensed to prescribe in Illinois.  Emergency kits shall be sealed in some manner that will indicate when the kit has been opened.  A label shall be affixed to the outside of the emergency kit indicating the beyond use date of the emergency kit.  The beyond use date of the emergency kit shall be the earliest beyond use date of any drug contained in the kit.  After an emergency kit has been used or upon discovery that the seal has been broken or upon the occurrence of the beyond use date, the kit shall be secured and returned to the pharmacy to be checked and/or restocked by the last authorized user.  If the pharmacy is closed at that time, the kit shall be returned when it opens. An automated dispensing and storage system may be used as an emergency kit. This use shall be in compliance with Section 1330.680.

 

3)         Whenever any drug is not available from night cabinets or emergency kits, and the drug is required to treat the immediate needs of a patient, the drug may be obtained from the pharmacy in sufficient quantity to meet the immediate need by an authorized nurse. When medication is removed from the pharmacy by an authorized nurse, a copy of the licensed practitioner's order authorizing the removal of the medication shall be conspicuously placed in the pharmacy with the container from which the drug was removed so that it will be found by a pharmacist and checked promptly. A form shall be available in the pharmacy upon which shall be recorded the signature of the authorized nurse who removed the medication, the name, strength (if applicable) and quantity of medication removed.

 

(Source:  Amended at 47 Ill. Reg. 8352, effective June 2, 2023)

 

Section 1330.530  Onsite Institutional Pharmacy Services

 

a)         Onsite Pharmacies. A pharmacy located in facilities licensed under the Nursing Home Care Act, the Hospital Licensing Act, or the University of Illinois Hospital Act, or that are operated by the Department of Human Services or the Department of Corrections, and that provide pharmacy services to residents, patients, employees, prescribers and students of these facilities, shall, in addition to other requirements of the Act and this Part, comply with this Section.

 

b)         Recordkeeping Requirements

 

1)         Every prescription or medication order filled or refilled shall contain the name, initials or other unique identifier of the pharmacist (and pharmacy technician if one is used) who fills or refills the prescription or medication order, or the name, initials or other unique identifier may be recorded on another appropriate, uniformly maintained and readily retrievable record that indicates, at least, the following information:

 

A)        The name and dosage form of the drug;

 

B)        The date of filling or refilling; and

 

C)        The quantity dispensed.

 

2)         No prescription may be dispensed for a period in excess of 15 months from the date of the original issuance of the prescription by the prescriber.

 

3)         The pharmacist-in-charge shall maintain or have access to the following records for at least 5 years or as otherwise required by law:

 

A)        Records of medication orders and medication administration to patients;

 

B)        Procurement records for controlled substances;

 

C)        Records of packaging, bulk compounding or manufacturing; and

 

D)        Records of actions taken pursuant to drug recalls.

 

c)         Labeling Requirements

 

1)         All medication repackaged by the pharmacy for future use inside the institution or facility and not intended for immediate dispensing to a specific patient shall be identified as follows:

 

A)        Single dose or multi-dose drugs, except sterile solutions to which a drug has been added, shall be labeled with:

 

i)          Brand and/or generic name;

 

ii)         Strength (if applicable);

 

iii)        Beyond use date; and

 

iv)        Reference code to identify source and lot number.

 

B)        Sterile solutions to which drugs have been added shall contain on the outer label:

 

i)          Name, concentration and volume of the base sterile solution;

 

ii)         Name and strength of drugs added;

 

iii)        Beyond use date and time of the admixture; and

 

iv)        Reference code to identify source and lot number of drugs added.

 

2)         All medication prepared by the pharmacy for immediate dispensing to a specific patient or resident in the institution or facility shall be identified as follows:

 

A)        Single dose or multi-dose drugs, except parenteral solutions to which a drug has been added, shall be identified with:

 

i)          Brand and/or generic name; and

 

ii)         Strength (if applicable).

 

B)        Sterile solutions to which drugs have been added shall be identified with:

 

i)          Name, concentration and volume of the base sterile solution;

 

ii)         Name and strength of drugs added; and

 

iii)        Beyond use date and time of the admixture.

 

C)        All medication dispensed to a specific patient in the institution shall be dispensed in a container identified with the name of the patient and the patient's location.  Those institutions or facilities utilizing a unit-dose and medication cart system may identify the name of the patient and the patient's location on the outside of the bin of the medication cart, when those carts are filled by the pharmacy.

 

3)         Labels on all medications dispensed by the pharmacy for immediate dispensing to a patient being discharged, emergency room patient and/or employee shall contain the following:

 

A)        The name and dosage form of the drug;

 

B)        The date filled;

 

C)        The quantity dispensed; and

 

D)        Directions for use.

 

4)         Investigational new drugs, authorized by the U.S. Food and Drug Administration, shall be dispensed pursuant to a valid prescription order of the principal physician-investigator or the principal physician-investigator's authorized clinician.  All investigational drugs shall be stored in and dispensed from the pharmacy and shall be identified with the following information:

 

A)        Name of drug and strength (if applicable);

 

B)        Beyond use date;

 

C)        Reference code to identify source and lot number;

 

D)        A label indicating "For Investigational Use Only"; and

 

E)        Name and location of the patient.  Those institutions or facilities utilizing a unit-dose and medication cart system may identify the name of the patient and the patient's location on the outside of the bin of the medication cart, when those carts are filled by the pharmacy.

 

5)         A pharmacist providing a copy of a prescription to an ultimate consumer for the purpose of transfer or any other purpose shall cancel the face of the original prescription and record the date the copy is issued, to whom issued, and the pharmacist's signature on the face of the original prescription. Copies of prescriptions shall be marked "For Information Purposes Only" and require prescriber authorization to fill.

 

d)         Staffing of the Pharmacy

 

1)         The responsibilities of the pharmacist-in-charge shall include:

 

A)        Supervision of all the activities of all employees as they relate to the practice of pharmacy;

 

B)        Establishment and supervision of the method and manner for storage, dispensing and safekeeping of pharmaceuticals in all areas of the institution or facility, including maintenance of security provisions to be used when the pharmacy is closed.  The following security provisions shall be utilized:

 

i)          The pharmacy shall be staffed at all times by a registered pharmacist during open hours; and

 

ii)         Only registered, certified, and licensed individuals under this Part shall have access to the pharmacy, except as provided in Section 1330.530(e)(1);

 

C)        Establishment and supervision of the recordkeeping system for the purchase, sale, delivery, possession, storage and safekeeping of drugs;

 

D)        The development and implementation of a procedure to be utilized in the event of a drug recall that can be readily activated to assure that all drugs included on the recall are returned to the pharmacy for proper disposition;

 

E)        Establishment of specifications for the procurement of all drugs that will be dispensed by the pharmacy; and

 

F)         Establishment and supervision of a method of documenting an oral prescription from a practitioner licensed to prescribe to a pharmacist and for transmission of that information to the appropriate members of the nursing staff of the institution or facility.

 

2)         The operations of the pharmacy and the maintenance of security provisions are the responsibility of the pharmacist-in-charge whether the owner is a sole proprietor, partnership, association, corporation or any other entity.

 

3)         Within 30 days after the change of a pharmacist-in-charge, the Division shall be notified in writing by the departing pharmacist-in-charge.

 

4)         The departing pharmacist-in-charge shall, on the effective date of the change, inventory the following controlled substances:

 

A)        All Schedule II drugs, as defined in the Illinois Controlled Substances Act, by actual physical count; and

 

B)        All other scheduled drugs, as defined in the Illinois Controlled Substances Act, by estimated count.

 

5)         The inventory shall constitute, for the purpose of this Section, the closing inventory of the departing pharmacist-in-charge and the initial inventory of the incoming pharmacist-in-charge.  This inventory record shall be preserved in the pharmacy for a period of 5 years.  An affidavit attesting to the completion and preservation of the inventory record bearing the date of the inventory and the signatures of the departing and incoming pharmacist-in-charge shall be submitted to the Division, at its principal office, within 30 days after the change in the pharmacist-in-charge.

 

6)         Failure on the part of a registrant to provide the affidavit required in subsection (d)(5) shall be grounds for denying an application or renewal application for a pharmacy license or for disciplinary action against a registrant.  Denial shall be based on the recommendation of the Board.

 

7)         In the event the departing pharmacist-in-charge refuses to complete the inventory as provided for in subsection (d)(4), or that pharmacist-in-charge is incapacitated or deceased, the initial inventory for the incoming pharmacist-in-charge shall be the inventory as completed by the incoming pharmacist-in-charge.  The incoming pharmacist-in-charge will not be responsible for any discrepancy that may exist in the inventory prior to initial inventory.

 

8)         When the accuracy, relevance or completeness of any submitted documentation is reasonably questioned by the Division because of lack of information, discrepancies or conflicts in information given, or a need for clarification, the registrant will be required to:

 

A)        Provide information as may be necessary; and/or

 

B)        Appear for an interview before the Board to explain the relevance or sufficiency, clarify information given or clear up any discrepancies or conflicts in information.

 

9)         Pharmacists and pharmacies are prohibited from accepting from patients or their agents for reuse, reissue or resale dispensed medications, chemicals, poisons or medical devices, except for:

 

A)        Medical devices that can be properly sanitized prior to reuse, resale or re-rent; and

 

B)        Medications that are dispensed and stored under conditions defined and supervised by the pharmacist and are unopened in sealed, intact and unaltered containers that meet the standards for light, moisture and air permeation as defined by a current United States Pharmacopeia − National Formulary published by the United States Pharmacopeial Convention, Inc.

 

e)         Medication Dispensing in the Absence of a Pharmacist. The availability of necessary medications for immediate therapeutic use during those hours when the institutional pharmacy is not open shall be met in the following manner:

 

1)         An after-hour cabinet, which is a locked cabinet or other enclosure located outside of the pharmacy area containing a minimal supply of the most frequently required medication, may be utilized provided that only personnel specifically authorized by the institution in which the pharmacy is located may obtain access and it is sufficiently secure to deny access to unauthorized persons.  After-hour cabinets shall only be used in the absence of a pharmacist.  When medication is removed from the cabinet or enclosure, written physician's orders authorizing the removal of the medication shall be placed in the cabinet or enclosure.  A log shall be maintained within the cabinet or enclosure and authorized personnel removing medication shall indicate on the log the signature of the authorized personnel removing the medication, name of the medication removed, the strength (if applicable), the quantity removed and the time of removal. An automated dispensing and storage system may be used as an after hours cabinet. This use shall be in compliance with Section 1330.680.

 

2)         Emergency kits containing those drugs that may be required to meet the immediate therapeutic needs of the patient, and that are not available from any other source in sufficient time to prevent risk of harm to patients by delay resulting from obtaining the drugs from the other source, may be utilized.  Emergency kits shall be supplied and maintained under the supervision of a pharmacist.  Drugs shall be removed from emergency kits only by authorized pharmacy personnel, persons authorized to administer medication pursuant to a valid order by a practitioner licensed to prescribe in Illinois.  Emergency kits shall be sealed in some manner that will indicate when the kit has been opened.  A label shall be affixed to the outside of the emergency kit indicating the beyond use date of the emergency kit.  The beyond use date of the emergency kit shall be the earliest beyond use date of any drug contained in the kit.  After an emergency kit has been used or upon discovery that the seal has been broken or upon the occurrence of the beyond use date, the kit shall be secured and returned to the pharmacy to be checked and/or restocked by the last authorized user.  If the pharmacy is closed at such time, the kit shall be returned when it opens. An automated dispensing and storage system may be used as an emergency kit. This use shall be in compliance with Section 1330.680.

 

3)         Whenever any drug is not available from night cabinets or emergency kits, and the drug is required to treat the immediate needs of a patient, the drug may be obtained from the pharmacy in sufficient quantity to meet the immediate need by an authorized nurse.  When medication is removed from the pharmacy by an authorized nurse, a copy of the licensed practitioner's order authorizing the removal of the medication shall be conspicuously placed in the pharmacy with the container from which the drug was removed so that it will be found by a pharmacist and checked promptly.  A form shall be available in the pharmacy upon which shall be recorded the signature of the authorized nurse who removed the medication, the name, strength (if applicable) and quantity of medication removed.

 

4)         Drugs may be dispensed from the emergency room only by a practitioner licensed to prescribe and dispense, and only to patients treated in the institution.  This shall occur only during hours in which outpatient institutional pharmacy services are not available.  The quantity dispensed should be limited to no more than a 72 hour supply, except for antimicrobial drugs and unit of use packages (e.g., inhalers, ophthalmic, otics, etc.), to meet the immediate needs of the patient until pharmacy services are available.  Drugs dispensed in this manner must meet all labeling requirements pertaining to community pharmacies as specified in Section 1330.500.  There shall be written policies and procedures, approved by the medical staff, regarding the dispensing of drugs from the emergency room.

 

f)         Pharmacies that compound and dispense sterile products shall comply with Section 1330.640.

 

g)         Pharmacies that utilize automated dispensing and storage systems shall comply with Section 1330.680.

 

(Source:  Amended at 47 Ill. Reg. 8352, effective June 2, 2023)

 

Section 1330.540  Nuclear Pharmacy Services

 

a)         Pharmacies that provide and/or offer for sale radiopharmaceuticals shall, in addition to any other requirements of the Act and this Part, comply with this Section.

 

b)         Prior to issuance of a pharmacy license to practice as a nuclear pharmacy:

 

1)         The pharmacy shall provide a copy of its Illinois Radioactive Material License issued by the Illinois Emergency Management Agency in accordance with the Radiation Protection Act [420 ILCS 40].

 

2)         The Division shall conduct an on-site inspection of the facility.

 

c)         The pharmacy shall have:

 

1)         Space commensurate with the scope of services provided, but at least 300 square feet; and

 

2)         A radioactive storage and product decay facility separate from and exclusive of the "hot" laboratory, compounding, dispensing, quality assurance and office areas.

 

d)         Each nuclear pharmacy shall have the following equipment:

 

1)         Laminar flow hood;

 

2)         Fume hood – minimum of 30 inches in height, which shall be vented through a filter with a direct outlet to the outside;

 

3)         Dose calibrator;

 

4)         Refrigerator;

 

5)         Class A prescription balance or a balance of greater sensitivity;

 

6)         Single-channel or multi-channel gamma scintillation counter;

 

7)         Microscope;

 

8)         Low level, thin-window portable radiation survey meter;

 

9)         Drawing station – lead glass and lead lined;

 

10)         Syringe shields; and

 

11)         Energy Compensated Geiger Mueller (GM) Probe or ion chamber.

 

e)         Each nuclear pharmacy shall have the following reference texts available:

 

1)         The current edition or revision of the United States Pharmacopoeia – Dispensing Information;

 

2)         The current edition or revision of the United States Pharmacopoeia/National Formulary;

 

3)         State and federal regulations governing the use of applicable radioactive material; and

 

4)         U.S. Public Health Service Radiological Health Handbook.

 

f)         Pharmacist-in-Charge

 

1)         The pharmacist-in-charge for a nuclear pharmacy shall meet the requirements set forth in subsection (i).  The responsibilities of the pharmacist-in-charge shall include:

 

A)        Supervision of all the activities of all employees as they relate to the practice of nuclear pharmacy;

 

B)        Establishment and supervision of the record keeping system for the purchase, acquisition, disposition, sale, delivery, possession, storage and safekeeping of radiopharmaceuticals; and

 

C)        Establishment and maintenance of security provisions, which shall include the following:

 

i)          There shall be no public access to the pharmacy hot lab/dispensing area; and

 

ii)         In the absence of a nuclear pharmacist, all radiopharmaceuticals shall be locked and accessible only to a nuclear pharmacist or a pharmacy technician under direct supervision of the pharmacist; except, a licensed medical practitioner authorized to possess, use and administer radiopharmaceuticals may have access to radiopharmaceuticals in the absence of a nuclear pharmacist.

 

2)         Within 30 days after the change of a pharmacist-in-charge, the Division shall be notified in writing by the departing pharmacist-in-charge.

 

g)         Dispensing Radiopharmaceuticals

 

1)         A radiopharmaceutical shall be dispensed only upon a prescription order from a licensed medical practitioner authorized to possess, use and administer radiopharmaceuticals.

 

2)         No radiopharmaceutical shall be dispensed in the absence of a nuclear pharmacist except, a licensed medical practitioner authorized to possess, use, dispense and administer radiopharmaceuticals may dispense in the absence of a nuclear pharmacist.

 

3)         The amount of radioactivity in a preparation for dispensing shall be determined by radiometric methods for each individual preparation at the time of preparation, and calibrated for the anticipated time of administration.

 

h)         Labeling Requirements

 

1)         In addition to the labeling requirements of pharmaceuticals, as stipulated in the Act, the immediate outer container of a radioactive drug, diagnostic agent or device to be dispensed shall also be labeled to include:

 

A)        The standard radiation symbol;

 

B)        The words "Caution − Radioactive Material";

 

C)        The name of the radionuclide;

 

D)        The name of the chemical form;

 

E)        The amount of radioactive material contained, in milliCuries or microCuries, in the container contents at the time of calibration;

 

F)         If the container contents are in liquid form, the volume in milliliters;

 

G)        The requested calibration time for the amount of radioactivity contained;

 

H)        The prescription number; and

 

I)         The name or initials of the nuclear pharmacist filling the prescription.

 

2)         The immediate container shall be labeled with:

 

A)        The standard radiation symbol;

 

B)        The words "Caution − Radioactive Material";

 

C)        The name and address of the pharmacy;

 

D)        The prescription number;

 

E)        Name of radionuclide; and

 

F)         Name of chemical form.

 

i)          Nuclear Pharmacist Requirements.  A nuclear pharmacist who serves as the pharmacist-in-charge of a nuclear pharmacy and all other pharmacists employed in the pharmacy shall provide evidence to the Division of the following:

 

1)         Licensure as a pharmacist in the State of Illinois; and

 

2)         That he/she is named as an authorized user, or works under the supervision of a pharmacist who is named as an authorized user, on a commercial nuclear pharmacy license issued by the Illinois Emergency Management Agency (IEMA) or, when a nuclear pharmacist who works under a broad medical license at a university or research hospital has been approved as a user by that institution's radiation safety committee in accordance with conditions of the license issued by IEMA.

 

j)          Nothing in this Part shall prohibit the operation of a nuclear medicine laboratory or any other department that is operated under the direct supervision of a licensed medical practitioner authorized to possess, use and administer radiopharmaceuticals.

 

Section 1330.550  Nonresident Pharmacies

 

a)         The Division shall require and provide for an annual nonresident special pharmacy registration for all pharmacies located outside of this State that dispense medications for Illinois residents and mail, ship or deliver prescription medications into this State, including home pharmacies of remote pharmacies located in Illinois that are located outside of Illinois.  Unless there is a direct conflict between Illinois pharmacy law and the pharmacy laws of the state in which the nonresident pharmacy is located, nonresident pharmacies shall abide by all Illinois laws and rules when filling prescriptions for Illinois residents, except that pharmacists employed at those pharmacies shall not be required to be licensed in Illinois except as otherwise provided in this Part.  Beginning January 1, 2026, pharmacists-in-charge of nonresident pharmacies shall be licensed in Illinois.  Nonresident special pharmacy registration shall be granted by the Division upon the disclosure and certification by a pharmacy:

 

1)         That it is licensed in the state in which the dispensing facility is located and from which the drugs are dispensed;

 

2)         Of the location, names and titles of all principal corporate officers and all pharmacists who are dispensing drugs to residents of this State;

 

3)         That it complies with all lawful directions and requests for information from the board of pharmacy of each state in which it is licensed or registered, except that it shall respond directly to all communications from the Division concerning emergency circumstances arising from the dispensing of drugs to residents of this State;

 

4)         That it maintains its records of drugs dispensed to residents of this State so that the records are readily retrievable from the records of other drugs dispensed;

 

5)         That it cooperates with the Division in providing information to the board of pharmacy of the state in which it is licensed concerning matters related to the dispensing of drugs to residents of this State; and

 

6)         That, during its regular hours of operation, but not less than 6 days per week for a minimum of 40 hours per week, a toll-free telephone service is provided to facilitate communication between patients in this State and a pharmacist retained by the nonresident pharmacy who has access to the patients' records.  The toll-free number must be disclosed on the label affixed to each container of drugs dispensed to residents of this State.

 

b)         To obtain nonresident special pharmacy registration in Illinois, an applicant shall file an application with the Division, on forms provided by the Division, that includes:

 

1)         Disclosure and certification of information required in subsection (a); and

 

2)         The fee required by Section 1330.20.

 

c)         Nonresident special pharmacy registration shall expire on March 31 of each even-numbered year and may be renewed during the 60 days preceding the expiration date by paying the fee required by Section 1330.20.

 

(Source:  Amended at 48 Ill. Reg. 10225, effective June 28, 2024)

 

Section 1330.560  Remote Prescription/Medication Order Processing

 

a)         Any pharmacy may provide remote prescription/medication order processing services to any other pharmacy as provided in Section 25.10 of the Act and the following further requirements:

 

1)         Any nonresident pharmacy remote prescription/medication order processing services shall first be registered in its resident state and registered in this State.

 

2)         There shall be a secure, HIPAA compliant, electronic communication system that shall include but not be limited to computer, telephone and facsimile connections.

 

3)         The communication system shall give remote access to all relevant patient information to allow the pharmacist of the remote pharmacy to perform remote medication order processing that shall include all laboratory results and every patient's or resident's medication profile, if appropriate.

 

4)         The secure electronic communication system shall be maintained on a daily basis.  If this system malfunctions, the remote processing pharmacy shall cease operations related to the institution affected.

 

5)         Nothing in this Section shall relieve the pharmacist-in-charge of dispensing pharmacies of compliance with Sections 1330.520 and 1330.530.

 

b)         Recordkeeping Requirements

 

1)         A policy and procedure manual shall be maintained by the remote prescription/medication order processing pharmacy pertaining to the pharmacy's operations.  The manual shall:

 

A)        Be accessible to the remote prescription/medication order  processing pharmacy staff and the staff at the dispensing pharmacy;

 

B)        Be available for inspection by the Division;

 

C)        Outline the responsibilities of the remote prescription/medication order processing pharmacy staff and the staff at the dispensing pharmacy;

 

D)        Include a current list of the name, address, telephone number and license number of each pharmacist involved in remote prescription/medication order processing;

 

E)        Include policies and procedures for:

 

i)          Protecting the confidentiality and integrity of patient information;

 

ii)         Ensuring that pharmacists performing remote prescription /medication order processing have access to appropriate drug information resources;

 

iii)        Ensuring that medical and nursing staff when appropriate, understand how to contact a pharmacist;

 

iv)        Maintaining records to identify the name, initials or identification code of each pharmacist who performs any processing function;

 

v)         Complying with federal and State laws and regulations;

 

vi)        Operating or participating in a continuous quality improvement program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems;

 

vii)       Reviewing the written policies and procedures and documenting the review annually.

 

2)         Every pharmacist providing remote prescription/medication order processing services shall record on the order, in the computer system, or on another appropriate, unalterable, uniformly maintained and readily retrievable record the following information for every medication order or prescription processed on behalf of a dispensing pharmacy:

 

A)        The name, initials or other unique identifier of the pharmacist who verifies the medication order or prescription;

 

B)        The name of the patient or resident;

 

C)        The name, dose, dosage form, route of administration and dosing frequency of the drug;

 

D)        The date and time of verification;

 

E)        The name of the prescribing/ordering practitioner;

 

F)         Any other information that is required by the dispensing pharmacy being served for use in its own records.

 

3)         The records for medications entered at the remote prescription/medication order processing pharmacy must be distinguishable and readily retrievable from those entered at the institution being served.

 

4)         The pharmacist-in-charge of the remote prescription/medication order processing pharmacy shall maintain and have access to the following records for a minimum of 5 years:

 

A)        Records of medication orders processed;

 

B)        Records of the electronic communication system maintenance.

 

5)         The remote prescription/medication order processing pharmacy shall maintain a record containing the names and license numbers of all pharmacies to which they are providing services and the number of hours per day the services are being provided.

 

c)         All pharmacists providing remote prescription/medication order processing at a remote pharmacy shall be licensed in Illinois.  However, when pharmacists are providing remote prescription/medication order processing for a community pharmacy licensed in Illinois from a community pharmacy licensed in Illinois but located out-of-state, only the pharmacist-in-charge of the remote pharmacy must be licensed in Illinois.

 

d)         Only licensed pharmacists at the pharmacy providing remote pharmacy services shall conduct the drug utilization evaluation or review and validation of any order processed within the remote pharmacy, except as provided for in subsection (c).

 

(Source:  Amended at 39 Ill. Reg. 6267, effective April 23, 2015)

SUBPART F: PHARMACY STANDARDS

 

Section 1330.600  Security Requirements

 

Whenever the pharmacy (prescription area) is not occupied by a registrant, the pharmacy (prescription area) must be secured and inaccessible to non-licensed persons (employees and public).  This may be accomplished by measures such as walling off, locking doors or electronic security equipment, as approved by the Division.

 

(Source:  Amended at 39 Ill. Reg. 6267, effective April 23, 2015)

 

Section 1330.610  Pharmacy Structural/Equipment Standards

 

All pharmacies must comply with the following provisions:

 

a)         Notification shall be submitted to the Division that an existing pharmacy will be remodeled.

 

b)         Other than on-site institutional pharmacies, all dispensing, and drug storage areas of the pharmacy must be contiguous and have a connecting door for access between the pharmacy and drug storage area.

 

c)         The pharmacy area and all store rooms shall be well-lighted and properly ventilated.

 

d)         Refrigerators shall be for the exclusive use of prescription drugs.  No personal or food items shall be stored in the refrigerator.  Refrigeration shall be capable of maintaining temperature within a range compatible with the proper storage of drugs requiring refrigeration or freezing. 

 

e)         The pharmacy area shall not be used for storage of merchandise that interferes with the practice of pharmacy.

 

f)         Suitable current reference sources, either in book or electronic data form (available in the pharmacy or on-line), which shall include Facts and Comparisons www.factsandcomparisons.com or other suitable references determined by the Division to be pertinent to the practice carried on in the licensed pharmacy.

 

g)         A telephone shall be immediately accessible in the pharmacy area.

 

h)         These requirements are in addition to any other requirements found in this Part.

 

i)          At a minimum, the equipment and references listed in Section 1330.640 must be maintained at all dispensing pharmacies.

 

(Source:  Amended at 47 Ill. Reg. 8352, effective June 2, 2023)

 

Section 1330.620  Electronic Equipment Requirements for Remote Pharmacies

 

All remote pharmacies operating in Illinois shall meet the following equipment requirements, except that subsections (a) through (d) shall not apply to RAPS:

 

a)         The pharmacy shall have a computer, scanner, fax capability and printer.

 

b)         All prescriptions shall be scanned and sequentially numbered, and the prescription labels shall be produced on site and viewed at the home pharmacy.

 

c)         Scanned prescriptions shall be displayable on a computer terminal at both the remote pharmacy and home pharmacy.

 

d)         All patient's demographic and prescription information shall be viewable at both the remote and home pharmacy in real time.

 

e)         Prescriptions dispensed at the remote pharmacy site must be distinguishable from those dispensed at the home pharmacy.

 

f)         In all cases in which electronic data processing equipment is used, the original prescription (either hard copy or an exact, unalterable image) shall be retained on file according to law to assure access to the information contained on the prescription in the event of a computer malfunction.

 

(Source:  Amended at 39 Ill. Reg. 6267, effective April 23, 2015)

 

Section 1330.630  Sanitary Standards

 

a)         All pharmacies and equipment in the pharmacy shall be maintained in a clean condition and in good repair.

 

b)         All waste material shall be immediately deposited in an appropriate waste receptacle.

 

c)         There shall be a sink with hot and cold running water for the purposes of hand washing and drug dispensing.  No sink shall be required for pharmacies that do not maintain drug inventory.

 

d)         The pharmacy area shall be dry and free from vermin.

 

e)         Food and/or beverages shall only be placed in a designated area away from dispensing activities.

 

f)         Personal items shall not be placed in an area where they will interfere with dispensing activities.

 

Section 1330.640  Pharmaceutical Compounding Standards

 

No person shall compound, or sell or offer for sale, or cause to be compounded, sold or offered for sale any medicine or preparation under or by a name recognized in the United States Pharmacopoeia National Formulary, for internal or external use, which differs from the standard of strength, quality or purity as determined by the test laid down in the United States Pharmacopoeia National Formulary official at the time of such compounding, sale or offering for sale.  (Section 25 of the Act)  All pharmaceutical compounding standards, both sterile and nonsterile, shall be governed by the official USP-NF (USP 47-NF 42), as set forth in the 2024 edition of United States Pharmacopoeia (USP), 47^th Revision and the National Formulary, 42^nd Edition, Compounding Compendium, with the exception of USP Chapter <800> as it pertains to the handling of hazardous drugs in health care settings..

 

a)         A pharmacy may only dispense compounded drugs pursuant to a valid patient-specific prescription, except as provided in this Section.

 

b)         "Office use" means the administration of a non-patient specific compounded drug to a patient by a practitioner in the practitioner's office or by the practitioner in a health care facility or treatment setting.  "Office use" does not include a pharmacy's delivery of a compounded drug to a prescribing practitioner's office pursuant to a valid patient-specific prescription.

 

c)         Sterile compounding for office use is prohibited unless the pharmacy is in full compliance with 21 USC 353b, including becoming registered as an outsourcing facility and licensed as a wholesale drug distributor pursuant to the Wholesale Drug Distribution Licensing Act [225 ILCS 120].  However, a sterile compounded drug may be delivered to the prescribing practitioner's office for administration pursuant to a valid patient-specific prescription.

 

d)         A pharmacist may dispense and deliver a reasonable quantity of a nonsterile compounded drug to a practitioner for office use by the practitioner in accordance with this Section, provided:

 

1)         The quantity of compounded drug does not exceed the amount a practitioner anticipates may be used in the practitioner's office before the expiration of the beyond use date of the drug;

 

2)         The quantity of compounded drug is reasonable considering the intended use of the compounded drug and the nature of the practitioner's practice;

 

3)         The quantity of compounded drug for any practitioner, and all practitioners as a whole, is not greater than an amount the pharmacy is capable of compounding in compliance with pharmaceutical standards for identity, strength, quality and purity of the compounded drug that are consistent with United States Pharmacopoeia guidelines;

 

4)         The pharmacy maintains readily retrievable records of all compounded drugs ordered by practitioners for office use.  The records must be maintained for a minimum of five years and shall include:

 

A)        The name, address and phone number of the practitioner ordering the compounded drug for office use and the date of the order;

 

B)        The name, strength, quantity and dosage form of the compounded drug provided, including the number of containers and quantity in each;

 

C)        The date the drug was compounded;

 

D)        The date the compounded drug was provided to the practitioner; and

 

E)        The lot number and beyond-use date.

 

5)         The pharmacy affixes a label to any compounded drug that is provided for office use.  The label shall include:

 

A)        The name, address and phone number of the compounding pharmacy;

 

B)        The name, strength and dosage form of the compounded drug and a list of active ingredients and strengths.  If the number of active ingredients would prohibit proper labeling, then the pharmacist shall provide to the practitioner a complete list of the active ingredients and strengths (including those on the label);

 

C)        The pharmacy's lot number and beyond-use date;

 

D)        The quantity or amount in the container;

 

E)        The appropriate ancillary instructions, such as storage instructions, cautionary statements, or hazardous drug warning labels when appropriate; and

 

F)         The statement "For Office Use Only – Not for Resale".

 

e)         All pharmacies that compound drugs must maintain, at a minimum, the following standards and equipment:

 

1)         A separate storage area for materials used in compounding;

 

2)         Scales or measuring devices with sufficient accuracy for the products to be compounded;

 

3)         An area of the pharmacy used exclusively for compounding;

 

4)         A logbook or record keeping system to track each compounded drug, which must include the lot number, expiration date of components used, and beyond-use date of compounded drug.  This applies to each nonsterile compounded drug and each sterile compounded drug with a beyond-use date greater than 24 hours;

 

5)         The current edition of the USP Compounding Compendium.  This publication may be in electronic format and/or available via the internet;

 

6)         If engaged in veterinary drug compounding, "Plumb's Veterinary Drug Handbook" or any other similar publication approved by the Division;

 

7)         Consumable materials, as appropriate to the pharmacy services provided at that specific pharmacy, including but not limited to:  filter paper, powder papers, empty capsules, ointment jars, bottles, vials, safety closures, powder boxes, labels and distilled water;

 

8)         Drug Distribution and Control

 

A)        Patient Profile or Medication Record System.  A pharmacy generated patient profile or medication record system shall be maintained, in addition to the prescription file.  The patient profile or medication record system shall contain, at a minimum:

 

i)          Patient's name;

 

ii)         Date of birth or age;

 

iii)        Gender;

 

iv)        Compounded sterile drugs dispensed;

 

v)         Date dispensed, if off-site;

 

vi)        Date compounded;

 

vii)       Drug content and quantity;

 

viii)      Patient directions, if drug is administered off-site;

 

ix)        Other drugs or supplements the patient is receiving, if provided by the patient or the patient's agent; and

 

x)         Known drug sensitivities and allergies to drugs and foods.

 

B)        Labeling.  Each compounded drug dispensed to patients shall be labeled with the following information, using a permanent label:

 

i)          Name, address and telephone number of the licensed pharmacy, if not used within the facility;

 

ii)         Date dispensed and identifying number, if used off-site;

 

iii)        Patient's name and room number, if applicable;

 

iv)        Name of each drug component, strength, amount and dosage form;

 

v)         Directions for use and/or infusion rate, if used off site;

 

vi)        Prescriber's name, if used off-site;

 

vii)       Required controlled substances transfer warnings, when applicable;

 

viii)      Beyond-use date, and time if appropriate;

 

ix)        If used off-site, identity of compounding and dispensing pharmacist or other authorized individual; and

 

x)         Auxiliary label with storage requirements, if applicable.

 

C)        In addition to labeling requirements on the Pharmacy Practice Act [225 ILCS 85] and this Part, compounded drugs dispensed to patients shall have on the label or an auxiliary label the following:  "This prescription was specifically compounded in our pharmacy for you at the direction of your prescriber."

 

D)        The pharmacist-in-charge shall ensure that records are maintained for five years, are readily retrievable and in a format that provides enforcement agents an accurate and comprehensive method of monitoring distribution via an audit trail.  The records shall include at least the following information:

 

i)          Purchase records; and

 

ii)         Patient profile or medication;

 

9)         Delivery Service.  The pharmacist-in-charge shall ensure the environmental control of all preparations shipped or delivered off-site.  Therefore, any compounded pharmaceutical must be shipped or delivered to a patient off-site in temperature controlled (as defined by USP Standards) delivery containers; and

 

10)         Sales of compounded drugs to other pharmacies not under common ownership, or to clinics, hospitals or manufacturers, other than as provided in subsection (d), are not allowed, except for sales provided by pharmacies contracted to provide centralized prescription filling services pursuant to Section 25.5 of the Act, including compounding in anticipation of receiving a prescription or order based on routine, readily observed dispensing patterns.

 

f)         For sterile compounding, a pharmacy must comply with the following additional requirements:

 

1)         The following current resource materials and texts shall be maintained in the pharmacy and may be in electronic format:

 

A)        Copies of the Act and this Part, the Illinois Controlled Substances Act [720 ILCS 570], 77 Ill. Adm. Code 3100, 21 CFR (Food and Drugs), and the Hypodermic Syringes and Needles Act [720 ILCS 635];

 

B)        One compatibility reference, such as:

 

i)          ASHP's Handbook on Injectable Drugs;

 

ii)         King's Guide to Parenteral Admixtures; or

 

iii)        Any other Division-approved publication; and

 

C)        A file or reference on extended (more than 24 hours) stability data given to finished preparations.

 

2)         Staffing.  A pharmacist shall be accessible at all times to enable each licensed facility to respond to patients' and health professionals' questions and needs.  A 24-hour telephone number shall be included on the prescription label of compounded drugs and medication infusion devices if used off-site.

 

3)         Emergency Medications.  Pharmacies that dispense compounded sterile drugs to patients in facilities off-site or for administration in the patient's residence shall stock supplies and medications appropriate for treatment of allergic or other common adverse effects, to be dispensed upon the prescription or order of an authorized prescriber.

 

g)         Notwithstanding any other provision of this Section, a pharmacy may compound a reasonable quantity of sterile and nonsterile drug products for office use by a veterinarian.

 

h)         It shall be the ongoing responsibility of the pharmacist-in-charge to ensure that all pharmacists, student pharmacists, registered certified pharmacy technicians, and registered pharmacy technicians who participate in compounding activities are adequately trained for the type of compounding in which they participate.  Documentation of this training shall be maintained by the pharmacy at all times.

 

i)          Any pharmacy that, after initial licensure, chooses to add sterile compounding to the services it provides must be inspected by, and the compounding area must be approved by, the Department.  It shall be the responsibility of the pharmacist-in-charge to notify the Department and arrange for the inspection. 

 

j)          For the purposes of this Section, "off-site" for all pharmacies, other than an onsite institutional pharmacy, means outside the licensed premises of a pharmacy. "Off-site" for an onsite institutional pharmacy means outside the institution within which the pharmacy is located.

 

(Source:  Amended at 48 Ill. Reg. 10225, effective June 28, 2024)

 

Section 1330.650  Pharmacy Computer Regulations

 

a)         When electronic data processing equipment is employed by a pharmacy, input of drug information shall be performed by a pharmacist, or by a pharmacy technician or a certified pharmacy technician under the supervision of a pharmacist.  When orders are entered by pharmacy technicians or certified pharmacy technicians, the supervising pharmacist must verify the accuracy of the information entered.  The identity of the supervising pharmacist and the technician shall be maintained in the prescription record.

 

b)         Electronic data processing equipment or media, when used to store or process prescription information, shall meet the following requirements:

 

1)         Must guarantee the confidentiality of the information contained in the database.

 

2)         Must require that the transmission of electronic prescriptions from prescriber to pharmacist not be compromised by interventions, control or manipulation of the prescription by any other party.

 

Section 1330.660  Pharmacist-in-Charge

 

a)         No pharmacy shall be granted a license without a pharmacist being designated on the pharmacy license as pharmacist-in-charge.

 

b)         A pharmacy shall have one pharmacist-in-charge who shall be routinely and actively involved in the operation of the pharmacy.

 

c)         A pharmacist may be the pharmacist-in-charge for more than one pharmacy; however, the pharmacist-in-charge must work an average of at least 8 hours per week at each location where the pharmacist is the pharmacist-in-charge.  If the pharmacist-in-charge is not involved in verifying or dispensing prescriptions, the hours worked in the pharmacy must be documented.  If a pharmacist-in-charge is on a leave of more than 90 days, a new pharmacist-in-charge must be designated.

 

d)         The responsibilities of the pharmacist-in-charge shall include:

 

1)         Supervision of all activities of all employees as they relate to the practice of pharmacy;

 

2)         Establishment and supervision of the method and manner for storage and safekeeping of pharmaceuticals, including maintenance of security provisions to be used when the pharmacy is closed (see Section 1330.600); and

 

3)         Establishment and supervision of the recordkeeping system for the purchase, sale, delivery, possession, storage and safekeeping of drugs.

 

e)         The operations of the pharmacy and the establishment and maintenance of security provisions are the dual responsibility of the pharmacist-in-charge and the owner of the pharmacy.

 

f)         Within 30 days after a change of a pharmacist-in-charge, the Division shall be notified in writing by the departing pharmacist-in-charge.

 

g)         In addition to notifying the Division within 30 days, the departing pharmacist-in-charge shall, on the effective date of the change, inventory the following controlled substances:

 

1)         All Schedule II drugs, as defined in the Illinois Controlled Substances Act, by actual physical count; and

 

2)         All other scheduled drugs, as defined in the Illinois Controlled Substances Act, by estimated count.

 

h)         The inventory described in subsection (g) shall constitute, for the purpose of this Section, the closing inventory of the departing pharmacist-in-charge and the initial inventory of the incoming pharmacist-in-charge.  This inventory record shall be preserved in the pharmacy for a period of 5 years.  An affidavit attesting to the completion of the inventory and preservation of the inventory record, bearing the date of the inventory and the name and signatures of the departing and the incoming pharmacist-in-charge, shall be submitted to the Division at its principal office within 30 days after the change in the pharmacist-in-charge.

 

i)          In the event the departing pharmacist-in-charge refuses to complete the inventory as provided for in subsection (g), or that pharmacist-in-charge is incapacitated or deceased, the initial inventory for the incoming pharmacist-in-charge shall be the inventory as completed by the incoming pharmacist-in-charge.  The incoming pharmacist-in-charge will not be responsible for any discrepancy that may exist in the inventory prior to his or her initial inventory.

 

j)          When the accuracy, relevance or completeness of any submitted documentation is questioned by the Division, because of a lack of information, discrepancies or conflicts in information given, or a need for clarification, the registrant will be required to:

 

1)         Provide information as may be necessary; and/or

 

2)         Appear for an interview before the Board to explain the relevance or sufficiency, clarify information given, or clear up any discrepancies or conflict of information.

 

k)         Records shall be retained as provided for in Section 18 of the Act. Invoices for all legend drugs shall be maintained for a period of 5 years either on site or at a central location where records are readily retrievable. Invoices shall be maintained on site for at least one year from the date of the invoice.

 

l)          Whenever a pharmacy intends on changing or adding to the type of pharmacy services it offers, as listed in Sections 1330.500, 1330.510, 1330.520, 1330.530, 1330.540, 1330.560 and 1330.640, it shall notify the Division no less than 30 days prior to the change or addition.

 

(Source:  Amended at 48 Ill. Reg. 10225, effective June 28, 2024)

 

Section 1330.670  Compounded Sterile Preparation Standards (Repealed)

 

(Source:  Repealed at 42 Ill. Reg. 20022, effective November 9, 2018)

 

Section 1330.680  Automated Dispensing and Storage Systems

 

a)         This Section sets forth standards for pharmacies whose practice includes the use of automated dispensing and storage systems.  Automated dispensing and storage systems shall not be used in nuclear pharmacies.

 

b)         Automated Dispensing and Storage Systems

 

1)         Documentation as to type of equipment, serial numbers, content, policies and procedures, and locations shall be maintained on-site in the pharmacy for review by the Division.  Documentation shall include, but not be limited to:

 

A)        Name and address of the pharmacy or facility where the automated dispensing and storage system is operational;

 

B)        Manufacturer's name and model;

 

C)        Quality assurance policy and procedures to determine continued appropriate use and performance of the automated device; and

 

D)        Policies and procedures for system operation, safety, security, accuracy, patient confidentiality, access, controlled substances, data retention or archival, definitions, downtime procedures, emergency or first dose procedures, inspection, installation requirements, maintenance, medication security, quality assurance, medication inventory, staff education and training, system set-up and malfunction.

 

2)         Automated dispensing and storage systems shall be used only in settings that ensure medication orders and prescriptions are reviewed by a pharmacist in accordance with established policies and procedures and good pharmacy practice.  This provision shall not apply when used as an after-hours cabinet or emergency kit as provided in Section 1330.530(e).

 

3)         Automated dispensing and storage systems shall have adequate security systems and procedures, evidenced by written pharmacy policies and procedures, to:

 

A)        Prevent unauthorized access or use;

 

B)        Comply with any applicable federal and State regulations; and

 

C)        Maintain patient confidentiality.

 

4)         Records and/or electronic data kept by automated dispensing and storage systems shall meet the following requirements:

 

A)        All events involving access to the contents of the automated dispensing and storage systems must be recorded electronically;

 

B)        Records must be maintained by the pharmacy and must be readily available to the Division.  The records shall include:

 

i)          Identity of system accessed;

 

ii)         Identification of the individual accessing the system;

 

iii)        Type of transaction;

 

iv)        Name, strength, dosage form and quantity of the drug accessed;

 

v)         Name of the patient for whom the drug was ordered;

 

vi)        Identification of the registrants stocking or restocking and the pharmacist checking for the accuracy of the medications to be stocked or restocked in the automated dispensing and storage system; and

 

vii)       Such additional information as the pharmacist-in-charge may deem necessary.

 

5)         The stocking or restocking of all medications in the automated dispensing and storage systems shall be accomplished by registrants under the Act or, alternatively, the pharmacist-in-charge may designate a facility's appropriately trained facility employee that is licensed pursuant to the Nurse Practice Act [225 ILCS 65] or Physician Assistant Practice Act of 1987 [225 ILCS 95] to perform the stocking or restocking.  A pharmacist-in-charge who delegates stocking/restocking in this manner shall remain responsible for ensuring that the automated dispensing and storage system is stocked/restocked accurately and in accordance with established, written pharmacy policies and procedures.

 

6)         All medications stored in the automated dispensing and storage systems shall be packaged as a unit of use for single patient use (e.g., unit dose tab/cap, tube of ointment, inhaler, etc.) and labeled as specified in this subsection (b)(6):

 

A)        Sterile solutions to which a drug or diluent has been added, or that are not in their original manufacturer's packaging, shall contain the following information on the outer label:

 

i)          Name, concentration and volume of the base sterile solution;

 

ii)         Name and strength of drugs or diluent added;

 

iii)        Date and beyond use date of the admixture.  The beyond use date, unless otherwise specified in the individual compendia monograph, shall be no later than the beyond use date on the manufacturer's container or one year from the date the drug is repackaged; and

 

iv)        Reference code to identify source and lot number of drugs or diluent added.

 

B)        Non-parenterals repackaged for future use shall be identified with the following information:

 

i)          Brand and/or generic name;

 

ii)         Strength (if applicable);

 

iii)        Beyond use date.  Unless otherwise specified in the individual monograph, the beyond use date shall be no later than the beyond use date on the manufacturer's container or one year from the date the drug is repackaged; and

 

iv)        Reference code to identify source and lot number.

 

C)        Exceptions to the "unit of use" requirements in this subsection (b)(6) are as follows:

 

i)          Injectable medications stored in their original multi-dose vial (e.g., insulin, heparin) when the medication may be withdrawn into a syringe or other delivery device for single patient use;

 

ii)         Over-the-counter (OTC) products stored in their original multi-dose container (e.g., antacids, analgesics) when the medication may be withdrawn and placed into an appropriate container for single patient use; or

 

iii)        Topical preserved surgical facility medications, such as eyedrops, eardrops, creams and ointments, when properly stored in their original multidose containers, applied and handled per Centers for Disease Control and Prevention and Institute for Safe Medication Practices infection control guidelines and best practices, which include mandatory training and regular competency and monitoring protocols, provided multidose and in compliance with manufacturer labeling, and used, then discarded, within the manufacturer's expiration date or facility's "beyond use" date.

 

D)        The pharmacy providing services to the University of Illinois College of Veterinary Medicine shall be exempt from the requirement that all medications stored in the automated dispensing and storage systems be packaged as a unit for single patient use.  This exemption is solely for dispensing medications to animals.

 

7)         For medication removed from the system for on-site patient administration, the system must document the following information:

 

A)        Name of the patient or resident;

 

B)        Patient's or resident's unique and permanent identifier, such as admissions number or medical records number;

 

C)        Date and time medication was removed from the system;

 

D)        Name, initials or other unique identifier of the person removing the drug; and

 

E)        Name, strength and dosage form of the drug or description of the medical device removed.  The documentation may be on paper, via electronic media or via any other media or mechanisms as set forth by the Act or this Part or as approved by the Division.

 

8)         The automated dispensing and storage systems shall provide a mechanism for securing and accounting for medications once removed from and subsequently returned to the automated dispensing and storage systems (e.g., return bin).  No medication or device shall be returned directly to the system for immediate reissue or reuse by a non-registrant under the Act.  Medication or devices once removed shall not be reused or reissued except for:

 

A)        Medical devices that can be properly sanitized prior to reuse or reissue; and

 

B)        Medication that is dispensed and stored under conditions defined and supervised by the pharmacist and are unopened in sealed, intact and unaltered containers that meet the standards for light, moisture and air permeation as defined by the current USP/NF, or by the USP Conventions, Inc.

 

9)         The automated dispensing and storage systems shall provide a mechanism for securing and accounting for wasted medications or discarded medications.

 

10)         The quality assurance documentation for the use and performance of the automated dispensing and storage systems shall include at least the following:

 

A)        Safety monitors (e.g., wrong medications removed and administered to patient);

 

B)        Accuracy monitors (e.g., filling errors, wrong medications removed); and

 

C)        Security monitors (e.g., unauthorized access, system security breaches, controlled substance audits).

 

11)         Errors in the use or performance of the automated dispensing and storage systems resulting in patient hospitalization or death shall be reported to the Division by the pharmacist-in-charge within 30 days after acquiring knowledge of the incident.

 

12)         Policy and procedures for the use of the automated dispensing and storage systems shall include a requirement for pharmacist review of the prescription or medication order prior to the system profiling and/or removal of any medication from the system for immediate patient administration.  This does not apply to the following situations:

 

A)        The system is being used as an after-hours cabinet for medication dispensing in the absence of a pharmacist (see Section 1330.530(e)(1));

 

B)        The system is being used in place of an emergency kit (see Section 1330.530(e)(2));

 

C)        The system is being used to provide access to medication required to treat the immediate needs of a patient (see Section 1330.530(e)(3)).  A sufficient quantity to meet the immediate needs of the patient may be removed until a pharmacist is on duty and available to review the prescription or medication order.  A pharmacist shall check the orders promptly once on duty (e.g., floor stock system, emergency department, surgery, ambulatory care or same day surgery, observation unit, etc.).

 

13)         Policies and procedures for the use of the automated dispensing and storage systems shall include the following:

 

A)        List of medications to be stored in each system;

 

B)        List of medications qualifying for emergency or first dose removal without pharmacist prior review of the prescription or medication order.

 

14)         The pharmacist-in-charge shall maintain or have access to all records or documentation specified in this Section for 5 years or as otherwise required by law.

 

15)         A copy of all pharmacy policies and procedures related to the use of an automated dispensing and storage system shall be maintained at all locations where the system is being used.

 

c)         Duties and Responsibilities of the Pharmacist-in-Charge

 

1)         The pharmacist-in-charge shall be responsible for:

 

A)        Assuring that the automated dispensing and storage system is in good working order and accurately provides the correct strength, dosage form and quantity of the drug prescribed while maintaining appropriate recordkeeping and security safeguards;

 

B)        Establishment of a quality assurance program prior to implementation of an automated dispensing and storage system and the supervision of an ongoing quality assurance program that monitors appropriate use and performance of the automated dispensing and storage system, evidenced by written policies and procedures developed by the pharmacy;

 

C)        Providing the Division with written notice 30 days prior to the installation of, or at the time of removal of, an automated storage and dispensing system.  The notice must include, but is not limited to:

 

i)          The name and address of the pharmacy;

 

ii)         The address of the location of the automated dispensing and storage system, if different from the address of the pharmacy;

 

iii)        The automated dispensing and storage system's manufacturer and model;

 

iv)        The pharmacist-in-charge; and

 

v)         A written description of how the facility intends to use the automated storage and dispensing system;

 

D)        Determining and monitoring access to and the limits on access (e.g., security levels) to the automated storage and dispensing system. Access shall be defined by policies and procedures of the pharmacy and shall comply with any applicable State and federal regulations.

 

2)         Additional responsibilities of the pharmacist-in-charge or pharmacist designated by the pharmacist-in-charge shall include:

 

A)        Authorizing the assigning of access to, discontinuing access to, or changing access to the system;

 

B)        Ensuring that access to the medications complies with State and federal regulations, as applicable; and

 

C)        Ensuring that the automated dispensing and storage system is stocked/restocked accurately and in accordance with established, written pharmacy policies and procedures.

 

d)         An automated dispensing and storage system is authorized for use in any licensed hospital, long-term care facility, or hospice residence ("facility").  For all nonresident pharmacies, the pharmacist-in-charge and all pharmacy personnel who provide services while physically present at a facility located in Illinois must be licensed in Illinois.  In addition to compliance with all other provisions in this Section, an automated dispensing and storage system shall comply with the following:

 

1)         Drugs in the automated dispensing and storage system are not considered dispensed until removed from the system by authorized personnel at the facility, after being released by the pharmacy pursuant to a prescription, unless otherwise provided for in this Part.

 

2)         Only the doses of medication needed for contemporaneous administration may be removed from the automated pharmacy system at one time.

 

3)         Automated dispensing and storage systems utilized at a facility shall operate under the same license as the pharmacy utilizing it.

 

4)         All records shall be maintained for a period of 5 years either at the pharmacy providing services to the facility or a central location where records are readily retrievable.

 

5)         Only pharmacies under common ownership may share an automated pharmacy system at a facility.

 

(Source:  Amended at 48 Ill. Reg. 10225, effective June 28, 2024)

SUBPART G: PHARMACY OPERATIONS