1. A. A drug shall be dispensed only in packaging approved by the current U.S.P.-N.F. for that drug. In the absence of such packaging standard for that drug, it shall be dispensed in a well-closed container.

2. B. Drugs may be dispensed in compliance packaging for self-administration when requested by the patient or for use in hospitals or long-term care facilities provided that such packaging meets all current U.S.P.-N.F. standards for packaging, labeling and recordkeeping. Compliance packaging that is comprised of a series of individual containers or pockets labeled with the specific date and time when the contents of that container are to be taken, and which may contain more than one different drug, shall comply with USP-NF standards for customized patient medication packages to include:

   1. 1. If the packaging allows for the separation of the individual containers, the labels for each individual container shall be labeled with the identity of each of the drug products contained within; and
   2. 2. The main packaging label shall contain all the required elements for any outpatient prescription label and shall contain a physical description identifying each solid dosage form contained within the individual containers.

Statutory Authority

§ 54.1-2400 and Chapters 33 (§ 54.1-3300 et seq.) and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia.

Historical Notes

Derived from VR530-01-1 § 7.2, eff. October 25, 1989; amended, Virginia Register Volume 9, Issue 4, eff. December 16, 1992; Volume 10, Issue 1, eff. November 4, 1993; Volume 11, Issue 21, eff. August 9, 1995; Volume 25, Issue 24, eff. September 2, 2009.