D.C. Mun. Regs. tit. 22, r. 22-B1911

Current through Register Vol. 71, No. 50, December 13, 2024

Rule 22-B1911 - PACKAGING AND HANDLING OF DRUGS AND MEDICAL DEVICES

1911.1

The packaging and handling requirements of this section shall apply to all pharmacies, unless otherwise exempted by this chapter or the Director.

1911.2

A pharmacy shall dispense drugs or medical devices in new and clean containers or in the manufacturer's original container or package.

1911.3

A pharmacy shall dispense drugs in child-resistant containers unless there is written documentation that the patient has requested otherwise, pursuant to the Federal Poison Prevention Act of 1970, 16 C.F.R. Part 1700.

1911.4

A pharmacy shall not reuse a manufacturer's bottle or container.

1911.5

A pharmacy shall not reuse a bottle or container that has held toxic, adulterated, or misbranded substances.

1911.6

A pharmacy shall obtain drugs only from suppliers licensed or registered as required by federal and District law.

1911.7

A pharmacy shall obtain only drugs that are in the original manufacturer's or distributor's container.

1911.8

A pharmacist shall direct and supervise the compounding, repackaging, or prepackaging of drugs and make the final verification of the prepackaged product and document the verification.

1911.9

A pharmacy shall keep a log of drugs that have been compounded, repackaged, or prepackaged under a pharmacist's supervision. The log must contain the following information:

(a) The name of the drug;

(b) The name of the manufacturer or distributor;

(c) The manufacturer or distributor's lot or control number of the drug;

(d) The strength of the drug;

(e) The expiration date;

(f) The date of prepackaging or repackaging;

(g) The quantity of drugs prepared; and

(h) The name or initials of the pharmacist supervising the packaging.

1911.10

A pharmacy shall keep the log required under § 1911.09 of this chapter for five (5) years from the date of packaging. Records that are more than two (2) years old may be stored offsite as long as they can be retrieved within three (3) business days of a request.

1911.11

All drugs and medical devices held by a pharmacy shall be stored:

(a) In a proper and safe manner;

(b) In an appropriate container or package that provides for protection of the product;

(c) To insure complete and accurate identification of the product; and

(d) As required by the manufacturer, this chapter, and other applicable federal and District of Columbia laws or regulations.

D.C. Mun. Regs. tit. 22, r. 22-B1911

Final Rulemaking published at 38 DCR 6734, 6743 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008)