Part V. Packaging, Repackaging and Label Standards
18VAC110-30-210. Repackaging of controlled substances; records required; labeling requirements.
A. A licensee repackaging controlled substances 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 controlled substances repackaged, strength, if any, quantity prepared, initials of the licensee supervising the process, the assigned control number, or the manufacturer's or distributor's name and control number, and an expiration date.
B. The controlled substance name, strength, if any, the assigned control number, or the manufacturer's or distributor's name and control number, and an appropriate expiration date determined by the licensee in accordance with USP-NF guidelines shall appear on any subsequently repackaged or reconstituted units.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-2 § 5.1, eff. May 9, 1990; amended, Virginia Register Volume 10, Issue 1, eff. November 3, 1993; Volume 17, Issue 7, eff. January 17, 2001; Volume 22, Issue 10, eff. February 22, 2006.
18VAC110-30-220. Labeling of prescription as to content and quantity.
Any controlled substances sold by a licensee shall bear on the label of the container, in addition to other requirements, the following information:
1. The name and address of the practitioner and the name of the patient;
2. The date of the dispensing;
3. The drug name and strength, when strength is applicable:
a. For any drug product possessing a single active ingredient, the generic name of the drug shall be included on the label.
b. If a generic drug is dispensed when a prescription is written for a brand name drug, the label shall contain the generic name followed by the words "generic for" followed by the brand name of the drug prescribed, and the label shall also contain the generic's brand name or the manufacturer or distributor of the drug dispensed; and
4. The number of dosage units or, if liquid, the number of millimeters dispensed.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-2 § 5.2, eff. May 9, 1990; amended, Virginia Register Volume 17, Issue 7, eff. January 17, 2001; Volume 22, Issue 10, eff. February 22, 2006.
18VAC110-30-230. Packaging standards for controlled substance sold.
A controlled substance shall be sold only in packaging approved by the current U.S.P.-N.F. for the controlled substance. In the absence of such packaging standard for the controlled substance, it shall be dispensed in a well-closed container.
Statutory Authority
§§ 54.1-113, 54.1-2400 and 54.1-3304.1 of the Code of Virginia.
Historical Notes
Derived from VR530-01-2 § 5.3, eff. May 9, 1990.
18VAC110-30-240. Special packaging.
A. Each controlled substance sold to a person in a household shall be sold in special packaging, except when otherwise requested by the purchaser, or when such controlled substance is exempted from such requirements promulgated pursuant to the Poison Prevention Packaging Act of 1970, 15 USC §§ 1471-1476.
B. Each licensee may have a sign posted near the compounding and selling area advising the patients that nonspecial packaging may be requested.
C. If nonspecial packaging is requested, a signed release of such request shall be obtained from the patient or the patient's authorized agent and maintained for two years from the date of dispensing.
Statutory Authority
§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.
Historical Notes
Derived from VR530-01-2 § 5.4, eff. May 9, 1990; amended, Virginia Register Volume 10, Issue 1, eff. November 3, 1993; Volume 17, Issue 7, eff. January 17, 2001; Volume 22, Issue 10, eff. February 22, 2006.