N.J. Admin. Code § 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
N.J.A.C.
13:39-11A.15(b)1 and 6
through 14.
Notes
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