Section 1330.92  Division II Pharmacies

 

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

 

b)         Recordkeeping Requirements for Filling Prescriptions or Orders

 

1)         Every prescription or order dispensed shall be documented with the handwritten names, initials or other unique identifier of the pharmacist (and 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 registered pharmacy technician or registered student pharmacist, under the supervision of a pharmacist.

 

2)         Each pharmacy must maintain a recordkeeping system for 5 years, which 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 two 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 et seq. (1998)) and State law (e.g., the Pharmacy Practice Act of 1987 and the Illinois Controlled Substances Act).

 

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 where 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)         The label affixed to the drug container must indicate the initials or other unique identifier of the pharmacist who approves the dispensing of the medication order.  However, if the pharmacy is utilizing a drug distribution system which re-issues the same label, a separate record must be maintained which identifies the pharmacist approving each dispensing of the prescription or medication order.

 

5)         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 or order by the prescriber.

 

6)         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) (1998), and that contain no further amendments or editions, 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 which has been verified, dated and signed by the dispensing pharmacist; or

 

B)        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.

 

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

 

1)         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;

 

2)         The pharmacy must provide pharmaceutical services as defined in Section 3 of the Act a minimum of 40 hours per week.  A pharmacy is considered to be providing pharmaceutical services when a pharmacist is on call and available for consultation.

 

e)         Pharmacist-in-Charge

 

1)         No pharmacy shall be granted a certification 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 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)         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 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)(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 upon the recommendation of the Board.

 

7)         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 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 of 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 Pharmacopoeial (USP)/National Formulary, or by the United States Pharmacopeial Convention, Inc.

 

g)         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)         Expiration date and date of the admixture. Expiration date, unless otherwise specified in the individual compendia monograph, or beyond use date, shall be not later than the expiration 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)          Trade and/or generic name;

 

ii)         Strength (if applicable);

 

iii)         Expiration date.  Unless otherwise specified in the individual monograph, the expiration date or beyond use date, shall be not later than the expiration 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)       Expiration 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.

 

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

 

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

 

(Source:  Amended at 30 Ill. Reg. 16930, effective October 12, 2006)