Section 1330.91  Division I Pharmacies

 

a)         Retail pharmacies which engage in general 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 Section 1330.91.  A retail pharmacy which, in addition to offering pharmacy services to the general public, provides pharmacy services to an institution or facility listed in Sections 1330.92(a) need not register as a Division II pharmacy if the sales do not exceed 49% of total sales, but the pharmacy shall comply with requirements of Sections 1330.92(b), (c) and (d).

 

b)         Recordkeeping Requirements for Filling Prescriptions

 

1)         Every prescription filled or refilled shall contain the name, initials or other unique identifier of the Illinois licensed pharmacist who fills or refills the prescription.  Additionally, the label affixed to the drug container must indicate the name, initials or other unique identifier of the Illinois licensed pharmacist who filled or refilled the prescription.  No prescription may be filled or refilled for a period in excess of one year from the date of the original issuance of the prescription by the prescriber.

 

2)         Whenever a prescription is filled or refilled, by a registered pharmacy technician under the supervision of a pharmacist, the prescription shall contain the names, initials or other unique identifier of both the supervising pharmacist and the registered pharmacy technician who fills or refills 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, which 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 for the prescription.

 

B)        If the pharmacist doesn't otherwise indicate in a uniformly maintained record, he/she 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)         A pharmacist providing a copy of a prescription to an ultimate consumer for the purpose of transfer or any other purpose shall cancel the uniformly maintained record and record the date the copy is issued, to whom issued and his/her name, initials or unique identifier.  Copies of prescriptions shall be marked "For Information Purposes Only" and require a new prescription from the prescriber.

 

6)         Subject to Section 18 of the Act, any information which is required to be kept pursuant to this Section may be recorded and stored in a computerized pharmaceutical information system that meets the standards of performance required by the regulations of the Drug Enforcement Administration (21 CFR 1306) (1998), and which contain no further amendments or editions, 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 by way of 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.

 

In lieu of the printout, 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 by him/her 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.

 

7)         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.

 

c)         Transfer of Prescription Information

 

1)         A prescription may be transferred between pharmacies for the purpose of original fill or refill dispensing provided that:

 

A)        The transferor pharmacist invalidates the prescription on file and records to whom transferred, the date of issuance of such copy and the name of the transferor pharmacist issuing the transferred prescription order; and

 

B)        The transferee pharmacist, upon receiving the prescription directly from another pharmacist, records the following:

 

i)          The name, address and original prescription number of the pharmacy from which the prescription was transferred;

 

ii)         All information constituting a prescription order including the following:  name of the drug, original amount dispensed, date of original issuance of the prescription and number of valid refills remaining; and

 

C)        The transferee pharmacist informs the patient that the original prescription has been cancelled at the pharmacy from which it has been transferred.

 

2)         A prescription for Schedule III, IV and V drugs may be transferred only from the original pharmacy and only one time for the purpose of refill dispensing and may not be transferred further.  However, a pharmacist who is electronically sharing real-time on line computerized systems may transfer up to the maximum refills permitted by law and the prescriber's authorization in accordance with CFR 1306.26(a).

 

3)         Computerized systems must satisfy all information requirements of this subsection (c), including invalidation of the original prescription when transferred between pharmacies accessing the same prescription records or between pharmacies of the same ownership.  If those systems that access the same prescription records have the capability of cancelling the original prescription, pharmacies using such a system are exempt from the requirements of this subsection (c) if the transferred prescription can always be tracked to the original prescription order from the prescribing practitioner and the original prescription can be produced.

 

d)         Staffing of the Pharmacy

 

1)         Whenever the hours of the pharmacy (prescription department) differ from those of the establishment in which the pharmacy is located, there shall be compliance with the following:

 

A)        The schedule during which the practice of pharmacy is carried on in the pharmacy shall be conspicuously displayed.

 

B)        Whenever an establishment housing a pharmacy is open and a pharmacist is not present and available to provide pharmaceutical services as defined in Section 3 of the Act, a sign shall be conspicuously displayed stating in all capital letters:  PHARMACIST NOT ON DUTY; STATE LAW PROHIBITS FILLING OF PRESCRIPTIONS IN THE ABSENCE OF A PHARMACIST.

 

C)        No prescription may be dispensed when a pharmacist is not physically present in the establishment, or remotely supervising activities of pharmacy registrants, as permitted in this Part, and on duty.  Notwithstanding any other provision of this Part, any registrant may dispense over the counter emergency contraception to persons 18 years of age or older without the supervision of a pharmacist.

 

2)         The pharmacy must provide pharmaceutical services, as defined in Section 3 of the Act, to the public a minimum of 40 hours per week.  A pharmacy is considered providing Pharmaceutical Services when a pharmacist is physically present in the establishment and available for consultation.

 

e)         Pharmacist-in-Charge

 

1)         No pharmacy shall be granted a certificate of licensure without a pharmacist being designated on the pharmacy license as pharmacist-in-charge.  No pharmacist shall be designated as a pharmacist-in-charge on more than one pharmacy license.  The responsibilities of the pharmacist-in-charge shall include:

 

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

 

B)        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 as set forth in Section 1330.75; and

 

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

 

2)         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.

 

3)         Within 10 days after the change of a pharmacist-in-charge, the Division shall be so notified in writing by the departing pharmacist-in-charge.

 

4)         In addition to notifying the Division within 10 days, 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 Substance Act, by actual physical count; and

 

B)        All other scheduled drugs, as defined in the Illinois Controlled Substance 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 of the inventory 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 Department of Financial and Professional Regulation-Division of Professional Regulation, at its principal office, within 10 days after the change in the pharmacist-in-charge.

 

6)         Failure on the part of a registrant to provide the information required in subsections (e)(4) and (5) shall be grounds for denying an application or renewal application for a pharmacy license or for disciplinary action against a registrant.  Such action shall be based on the recommendation of the Board.

 

7)         When the accuracy, relevance or completeness of any submitted documentation is reasonably 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:

 

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

 

B)        Explain the relevance or completeness during an oral interview; or

 

C)        Appear for an oral interview before the Board when the information available to the Board is insufficient to evaluate compliance with this Section.

 

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

 

1)         Medical devices that can be properly sanitized prior to reuse, resale or rerent; and

 

2)         Medications and medical devices 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 the current United States Pharmacopoeia (USP)/National Formulary or by the United States Pharmacopoeial Convention, Inc.

 

g)         Pharmacies that compound and dispense parenteral products shall comply with Section 1330.99 of this Part.

 

h)         Pharmacies that utilize automated dispensing and storage systems shall comply with Section 1330.98 of this Part.

 

i)                    Pharmacies shall develop and implement 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.

 

j)          Duty of Retail Pharmacy to Dispense Contraceptives

 

1)         Upon receipt of a valid, lawful prescription for a contraceptive, a retail pharmacy serving the general public must dispense the contraceptive, or a suitable alternative permitted by the prescriber, to the patient or the patient's agent without delay, consistent with the normal timeframe for filling any other prescription, subject to the remaining provisions of this subsection (j).  If the contraceptive, or a suitable alternative, is not in stock, the pharmacy must obtain the contraceptive under the pharmacy's standard procedures for ordering contraceptive drugs not in stock, including the procedures of any entity that is affiliated with, owns, or franchises the pharmacy.  However, if the contraceptive, or a suitable alternative, is not in stock and the patient prefers, the prescription must be transferred to a local pharmacy of the patient's choice under the pharmacy's standard procedures for transferring prescriptions for contraceptive drugs, including the procedures of any entity that is affiliated with, owns, or franchises the pharmacy.  Under any circumstances an unfilled prescription for contraceptive drugs must be returned to the patient if the patient so directs. 

 

2)         Each retail pharmacy serving the general public shall use its best efforts to maintain adequate stock of emergency contraception to the extent it continues to sell contraception (nothing in this subsection (j)(2) prohibits a pharmacy from deciding not to sell contraception).  Whenever emergency contraception is out-of-stock at a particular pharmacy and a prescription for emergency contraception is presented, the pharmacist or another pharmacy registrant shall attempt to assist the patient, at the patient's choice and request, in making arrangements to have the emergency contraception prescription filled at another pharmacy under the pharmacy's standard procedures for transferring prescriptions for contraceptive drugs, including the procedures of any entity that is affiliated with, owns or franchises the pharmacy.

 

3)         Dispensing Protocol − In the event that a licensed pharmacist who objects to dispensing emergency contraception (an "objecting pharmacist") is presented with a prescription for emergency contraception, the retail pharmacy serving the general public shall use the following dispensing protocol:

 

A)        All other pharmacists, if any, then present at the location where the objecting pharmacist works (the "dispensing pharmacy") shall first be asked to dispense the emergency contraception (any pharmacist that does not object to dispensing these medications is referred to as a "non-objecting pharmacist").

 

B)        If there is an objecting pharmacist and no non-objecting pharmacist is then available at the dispensing pharmacy, any pharmacy (the "remote pharmacy") or other non-objecting pharmacist shall provide "remote medication order processing" (RMOP) to the dispensing pharmacy.  RMOP includes any and all services that a licensed pharmacist may provide, as well as authorizing a non-pharmacist registrant at the dispensing pharmacy, to dispense the emergency contraception to the patient under the remote supervision of a non-objecting pharmacist.  For purposes of this subsection (j) and the Pharmacy Practice Act, a registered pharmacy technician is authorized to engage in RMOP involving emergency contraception.

 

i)          All remote pharmacies and other non-objecting pharmacists providing RMOP shall be licensed by the State of Illinois.

 

ii)         There shall be a secure, HIPAA-compliant, electronic communication system that shall include, but not necessarily be limited to, telephone and/or facsimile connections that allows communication between the remote pharmacy or other non-objecting pharmacist and the dispensing pharmacy.  Any electronic communication system allowing the remote pharmacy or other non-objecting pharmacist providing RMOP to access a patient's emergency contraception prescription information and the National Drug Code number for the emergency contraception being dispensed shall constitute and be considered a sufficient communication system that is compliant with this subsection (j) and the Pharmacy Practice Act for purposes of RMOP involving emergency contraception.  RMOP shall not be considered, or be subject to the requirements applicable to, telepharmacy as defined in the Pharmacy Practice Act or this Part.

 

iii)         Nothing in this subsection (j) shall otherwise relieve the pharmacist-in-charge of each participating remote pharmacy and dispensing pharmacy, or other non-objecting pharmacist, of compliance with the Pharmacy Practice Act and this Part, provided that compliance with the protocols in this Section shall be considered by the Department to be in compliance.

 

iv)        Recordkeeping Requirements − A policy and procedure manual (which may be maintained in electronic form) shall be maintained by each participating dispensing and remote pharmacy that is accessible to each non-objecting pharmacist pertaining to the pharmacy's or pharmacist's (as applicable) operations with respect to RMOP.  These RMOP policies and procedures need not be contained in a stand-alone manual applicable solely to RMOP, but rather may be incorporated as part of any existing pharmacy policy and procedure manual that any pharmacy or pharmacist performing RMOP can access.  The manual shall:

 

•     Be accessible to each participating dispensing and remote pharmacy's staff, or other non-objecting pharmacists, who are involved in RMOP and dispensing;

 

•     Be available for inspection by the Department;

 

•     Outline the responsibilities of the dispensing pharmacy staff and the remote pharmacy staff, or other non-objecting pharmacists, who are involved in RMOP;

 

•     Include a process to identify the name, address, telephone number, and license number of each pharmacist involved in RMOP;

 

•     Be reviewed by the owner or operator of the pharmacies on a regular basis; and

 

•     Include policies and procedures for:

 

Protecting the confidentiality and integrity of patient information;

 

Ensuring that pharmacists at the remote pharmacy, or other non-objecting pharmacist, performing prospective drug utilization review have access to appropriate drug information resources;

 

Ensuring that staff at the dispensing pharmacy understand how to contact a pharmacist who can perform RMOP;

 

Maintaining records to identify the name, initials, or identification code of each pharmacist who performs any RMOP function for a medication order; and

 

Complying with federal and State laws and regulations.

 

v)         Every pharmacist providing RMOP service at a remote pharmacy or otherwise shall ensure that the following information is recorded on the order, in the computer system, or on another appropriate, unalterable, uniformly maintained and readily retrievable record for every drug order or prescription for emergency contraception processed by the remote pharmacy or other non-objecting pharmacist on behalf of a dispensing pharmacy:

 

•     The name, initials or other unique identifier of the non-objecting pharmacist who verifies the drug order or prescription;

 

•     The name of the patient;

 

•     The dose, dosage form, route of administration and dosing frequency of the drug;

 

•     The date and time of verification; and

 

•     The name of the prescribing/ordering physician.

 

vi)        The pharmacists-in-charge of the dispensing pharmacies shall maintain and have access to the following records for a minimum of 5 years:

 

•     Records of emergency contraception medication orders processed;

 

•     Records of the electronic communication system maintenance, if any.

 

vii)        Staffing of the Remote Pharmacies

 

•     The responsibilities of the pharmacist-in-charge at each participating remote pharmacy, or other non-objecting pharmacist, providing RMOP shall include (except to the extent otherwise set forth in this subsection (j) as to objecting pharmacists):

 

Supervision of all the activities of all employees as they relate to the practice of pharmacy.

 

Establishment and supervision of the recordkeeping system for all the documents, electronic communication and all the transfers of information between the dispensing and remote pharmacies or other non-objecting pharmacists participating in RMOP.

 

The operation of the pharmacy and maintenance of security provisions for the records and the electronic communication system of the pharmacy or other location from which a non-objecting pharmacist engages in RMOP.  The owner of the pharmacy shall be equally responsible.

 

•     Within 30 days after the change of a pharmacist-in-charge, the Department shall be so notified in writing by the departing pharmacist-in-charge or by the owner of the pharmacy.

 

•    All pharmacies participating in RMOP shall be licensed in Illinois.

 

•    Only licensed pharmacists shall conduct the drug utilization evaluation or review and validation of any order processed.

 

4)         A retail pharmacy that serves the general public is responsible for ensuring either that there is a non-objecting pharmacist scheduled at all times the pharmacy is open, or that there is a licensed pharmacist available to perform RMOP for emergency contraception at all times the pharmacy is open and no non-objecting pharmacist is available at the pharmacy.

 

5)         For the purposes of this subsection (j), the term "contraceptive" shall refer to all FDA-approved drugs or devices that prevent pregnancy.

 

6)         Nothing in this subsection (j) shall interfere with a pharmacist's screening for potential drug therapy problems due to therapeutic duplication, drug‑disease contraindications, drug-drug interactions (including 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 225 ILCS 85/3(q).

 

k)         Notice of rights regarding the dispensing of contraceptives.

 

1)         Each Division I pharmacy must prominently display the notice described in subsection (k)(2) of this Section and include information regarding how to file a complaint with the Division.  The notice must be on 8.5 inch by 11 inch paper and otherwise conform with the format prescribed by subsection (k)(2).  The notice must be clearly visible from the area at which the pharmacy intakes prescriptions.  The Department's website shall provide a template for approved format of the notice and that template shall include required information regarding how to file a complaint with the Division, in accordance with the Department's administrative hearing rules located at 68 Ill. Adm. Code 1110.  The licensee shall be accorded all process provided for in 68 Ill. Adm. Code 1110.

 

2)         Form and text of notice:

 

IF YOU USE CONTRACEPTIVES KNOW YOUR RIGHTS.

 

If this pharmacy dispenses prescription contraceptives, then you have the following rights under Illinois law:

 

The pharmacy must dispense your prescribed contraceptives without delay, consistent with the normal timeframe for filling any other prescription.

 

When your contraceptive is out of stock, you have the following options: the pharmacy must cooperate with your doctor to determine a suitable alternative, order the contraceptive, or transfer the prescription to another pharmacy of your choice.

 

You can instruct the pharmacy to return the prescription slip to you at any time prior to dispensing.

 

You may file a complaint with the Department of Financial and Professional Regulation-Division of Professional Regulation through the Department's website http://www.idfpr.com.

 

(Source:  Amended at 32 Ill. Reg. 7116, effective April 16, 2008)