N.H. Admin. Code § Ph 702.02

Current through Register No. 50, December 12, 2024

Section Ph 702.02 - Prepackaging of Drugs

(a) Drugs shall be prepackaged in quantities suitable for internal distribution only by a pharmacist or by supportive personnel under the direct supervision of a pharmacist.

(b) The label of a prepackaged unit shall indicate the:

(1) Brand name and strength of the drug, or if no brand name, the generic name, strength, and name of the manufacturer or distributor;

(2) Assigned in-house, quality control lot number;

(3) Expiration date; and

(4) Quantity of the drug, if the quantity is greater than one.

(c) The pharmacist who prepackages or supervises prepackaging shall maintain a written or electronic record that contains at least the following information:

(1) Name of the drug, strength, and dosage form;

(2) Assigned in-house, quality control lot number;

(3) Manufacturer or distributor;

(4) Manufacturer's lot number;

(5) Expiration date;

(6) Quantity per prepackaged unit;

(7) Number of prepackaged units;

(8) Date packaged;

(9) Identifier of the prepacker; and

(10) Signature of the responsible pharmacist.

(d) Stock packages, repackaged units, and control records shall be quarantined together until checked/released by the pharmacist.

N.H. Admin. Code § Ph 702.02

#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED, 1-19-96

New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04

New. #8316, eff 3-26-05

Amended by Volume XXXV, Number 32 Filed August 13, 2015, Proposed by #10903, Effective 8/5/2015, Expires8/5/2025.

Amended by Volume XLII Number 28, Filed July 14, 2022, Proposed by #13398, Effective 6/16/2022, Expires 6/16/2032