18 Va. Admin. Code § 110-20-355

Current through Register Vol. 41, No. 6, November 4, 2024

Section 18VAC110-20-355 - Pharmacy repackaging of drug; records required; labeling requirements

A. Pharmacies in which bulk reconstitution of injectable, bulk compounding, or the repackaging or prepackaging of drugs is performed shall maintain adequate control records for a period of one year or until the expiration, whichever is greater. The records shall show the name of the drugs used; strength, if any; date repackaged; quantity prepared; initials of the pharmacist verifying the process; the assigned lot or control number; the manufacturer's or distributor's name and lot or control number; and an expiration date.

B. The drug name; strength, if any; the assigned lot or control number or the manufacturer's or distributor's name and lot or control number; and an appropriate expiration date determined by the pharmacist in accordance with USP guidelines shall appear on any subsequently repackaged or reconstituted units.

C. Repackaging of drugs shall be performed in compliance with USP-NF standards.

D. Pharmacies using automated counting devices or dispensers in which drugs are removed from manufacturer's original packaging and placed in bulk bins shall comply with the following requirements:

1. A bin filling record shall be maintained manually or in a computerized record for a period of one year from date of filling from which information can be readily retrieved for each bin including:

a. The drug name and strength, if any;

b. The name of the manufacturer or distributor;

c. Manufacturer's control or lot numbers and expiration date for all lots placed into the bin at the time of filling;

d. Any assigned lot number;

e. An expiration date determined according to USP guidelines for repackaging;

f. The date of filling; and

g. The pharmacist's initials verifying the accuracy of the process.

2. If more than one lot is added to a bin at the same time, the lot that expires first shall be used to determine the expiration date if shorter than a calculated date based on USP guidelines.

3. Each bin shall be labeled in such a manner as to cross-reference the information on the filling record with the correct expiration date.

4. If only one lot is added to a bin at one time, but a subsequent lot may be added before the first has cleared, the automated device shall be constructed to reasonably dispense the first lot before the second lot is dispensed, and the expiration date on the bin's label shall reflect the expiration date assigned to the earlier lot.

5. In the event of a drug recall involving one of multiple lots placed in a bin of an automated counting device in the last three months or if a recalled drug is known to remain in the bin, all drugs shall be removed from the bin and not used for patient care. The removal of drugs from the bin is not required if:

a. The technology of the automated counting device can ensure drugs in a particular lot have been cleared; or

b. The bin has been "run dry," with a record made of the "run dry" date, since the addition of the recalled lot number in which all drugs were completely removed prior to filling with a subsequent lot number.

6. An automated counting device shall be cleaned and maintained in accordance with recommended manufacturer guidelines and specifications.

E. A pharmacy may return a dispensed drug to stock for redispensing that has never left the pharmacy premises or the control of the pharmacy delivery agent pursuant to § 54.1-3411.1A 3 of the Code of Virginia under the following conditions:

1. An expiration date shall be placed on the label prior to returning the drug to stock. In the absence of stability data to the contrary, the date on the label may not exceed the expiration date on the manufacturer's container or one year from the date the drug was originally dispensed and placed in the prescription vial, whichever date is earlier.

2. The restocked drug shall be used to fill the next prescription received for that product. In the event that the drug is not dispensed prior to the new assigned expiration date, it shall be removed from working stock as expired and disposed of in accordance with 18VAC110-20-210.

3. If there is no lot number on the label of a drug returned to stock or on the prescription records that can be cross-referenced from the prescription label, the drug shall be removed from stock upon any recall of that drug product and returned to the manufacturer or otherwise disposed of in accordance with 18VAC110-20-210.

18 Va. Admin. Code § 110-20-355

Derived from Virginia Register Volume 15, Issue 8, eff. February 3, 1999; amended, Virginia Register Volume 20, Issue 23, eff. August 25, 2004; Volume 25, Issue 24, eff. September 2, 2009; Volume 29, Issue 21, eff. August 2, 2013.; Amended, Virginia Register Volume 36, Issue 06, eff. 12/11/2019.

Statutory Authority: §§ 54.1-2400 and 54.1-3307 of the Code of Virginia.