Minnesota Administrative Rules

6800.2700 RETURN OF DRUGS AND DEVICES.

Subpart 1.

Reuse.

Pharmacists and pharmacies are prohibited from accepting from patients or their agents for reuse, reissue, or resale any drugs, prescribed medications, chemicals, poisons, or medical devices; except that in a hospital with a licensed pharmacy, drugs, devices, or other items dispensed for hospital inpatient use only, which have not left the span of control of the pharmacy, may be returned to the pharmacy for reuse or disposal in accordance with good professional practice.

Subp. 2.

Drugs from nursing homes and assisted living facilities.

Drugs from nursing homes and assisted living facilities may be returned to the dispensing pharmacy. The returned drugs may be redispensed if:

A.

the consultant pharmacist can assure proper storage conditions for the drugs in the facility as specified in the United States Pharmacopeia, (United States Pharmacopeial Convention, Inc., Rockville, Maryland) and the drugs are stored within the facility in a secure area;

B.

the facility has 24-hour, on-site licensed nursing coverage seven days a week;

C.

the drugs are returned to the same pharmacy, which dispensed the drugs;

D.

the integrity of such packaging remains intact (no reconstituted drugs, drugs requiring refrigeration, or controlled substances may be so returned); and

E.

the drugs are received by the pharmacy in the original manufacturer's packaging or pharmacist packager's unit-dose, unit-of-use, or strip packaging with each tablet or capsule individually wrapped and labeled, or in blister cards, which indicate the drug name and strength, the packager's name, and the manufacturer's or packager's lot or batch number. Drugs packaged by a pharmacy may be returned only if the pharmacy can demonstrate to the board that its packaging material and procedures will provide a package that will meet or exceed the criteria for class B packaging established by the United States Pharmacopeia, (United States Pharmacopeial Convention, Inc., Rockville, Maryland), and that procedures have been developed and implemented to prevent the commingling of dosage units of different lot numbers or beyond-use dates.

Subp. 3.

Commingling.

Commingling of returned medication or mixing of lot numbers of returned medication, upon or prior to repackaging, shall result in such medication being deemed misbranded and subject to embargo under Minnesota Statutes, section 151.38. This prohibition shall not apply to the return of medical devices provided that proper sanitary procedures are used prior to the reuse, resale, or rerent thereof.

Statutory Authority:

MS s 151.06; 152.02

History:

18 SR 1145; 31 SR 1673

Published Electronically:

September 21, 2011