N.J. Admin. Code § 13:39-11A.12

Current through Register Vol. 56, No. 11, June 3, 2024

Section 13:39-11A.12 - Ingredient selection

(a) All ingredients used to compound non-sterile preparations shall be United States Pharmacopeia-National Formulary (USP-NF), analytical reagent (AR), certified American Chemical Society (ACS), or Food Chemicals Codex (FCC) grade substances. If a USP-NF, AR, ACS, or FCC grade substance ingredient is not available, the pharmacist shall establish the purity and safety of the ingredient by reasonable means, which may include lot analysis, manufacturer reputation, or reliability of source study.

(b) A manufactured drug product may be utilized as the source of an active ingredient. Only manufactured drug products from containers labeled with a batch control number and an unexpired expiration date shall be utilized as sources of active ingredients. When compounding with manufactured drug products, the compounding pharmacist shall consider all ingredients present in the drug product relative to the intended use of the compounded non-sterile preparation.

(c) Components used in the compounding of non-sterile preparations such as aliquots, triturates, stock solutions, buffering agents, or isotonic solutions may be prepared in advance and stored as pharmacy stock. The preparation of such products shall be documented in accordance with the requirements of 13:39-11A.15(b)1 and 6 through 14.

N.J. Admin. Code § 13:39-11A.12