Section 1330.95  Division V Pharmacies

 

a)         Pharmacies Required to Hold Division V Licenses

 

1)         Pharmacies which are located in or provide service to ambulatory care facilities, schools of veterinary medicine or other institutions or facilities.  In addition to other requirements of the Act and this Part, these pharmacies shall comply with this Section.

 

2)         Pharmacies that hold Division II licenses and provide pharmacy services to the general public.  In addition to other requirements of the Act and Rules, these pharmacies shall comply with Section 1330.92 and this Section.

 

3)         Pharmacies that hold Division III licenses and provide pharmacy services to the general public.  In addition to other requirements of the Act and Rules, these pharmacies shall comply with Section 1330.93 and this Section.

 

b)         Recordkeeping Requirements for Filling Prescriptions

 

1)         Every prescription filled or refilled shall contain the handwritten name, initials or other unique identifier of the person authorized to practice pharmacy under the provisions of the Act 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 person authorized to practice pharmacy in the State of Illinois 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, written or oral, is filled or refilled, by a registered pharmacy technician under the supervision of a pharmacist, the same shall contain the names, initials or other unique identifier of both the supervising pharmacist and the registered pharmacy technician who fills or refills the same.  Additionally, the label affixed to the drug container must indicate the same initials.

 

3)         Refilling a Prescription

 

A)        Each refilling of a prescription shall be entered on the prescription or on another 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 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 face of the original prescription and record the date the copy is issued, to whom issued, and his/her signature on the face of the original prescription.  Copies of prescriptions shall be marked "For Information Purposes Only", and may neither be filled nor refilled.

 

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 that 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 that shall, at a minimum, include 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 the correctness of refill 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 refill data that has been verified, dated and signed by the dispensing pharmacist.  This printout must include for each script refilled 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 a printout, the pharmacy shall maintain a bound log book, 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 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 the 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 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 from original pharmacy 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 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 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)        When the pharmacy is closed, the public and any employees not registered under the Act are to be prohibited access to the area.

 

C)        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.

 

D)        No prescription may be dispensed when a pharmacist is not physically present in the establishment and on duty.

 

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 may 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 the 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 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)         Such 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 Division, 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)(3), (4) and (5) shall be grounds for denying licensure 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 in accordance with Sections 30-39 of the Act and 68 Ill. Adm. Code 1110.

 

7)         When the accuracy, relevance or completeness of any submitted documentation 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 required to:

 

A)        Provide such 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.

 

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.

 

(Source:  Amended at 29 Ill. Reg. 13639, effective August 25, 2005)