Current through September 16, 2024
A pharmacy engaged in the practice of compounding nonsterile
compounded drug products shall, in addition to the requirements of NAC
639.67015, establish and maintain written policies and procedures for
compounding nonsterile compounded drug products to ensure that each final
compounded drug product has the identity, strength, quality and purity which
the compounded drug product is purported or represented to have. Such policies
and procedures must include, without limitation:
1. Policies and procedures for:
(a) Making and maintaining records concerning
the components used to compound each nonsterile compounded drug
product;
(b) The amount of each
component used to compound each nonsterile compounded drug product;
(c) The order of each step in the process of
compounding each nonsterile compounded drug product; and
(d) Including the information listed in
paragraphs (a), (b) and (c) on the original hard copy of the prescription
maintained in the written records of the pharmacy or in a computer system that
may be accessed to provide information:
(1)
For refilling the prescription; or
(2) Requested by the staff of the
Board.
2.
Control procedures for monitoring each final nonsterile compounded drug product
and validating the processes for compounding that may be responsible for
causing variability in the final nonsterile compounded drug product. Such
control procedures must include, without limitation, procedures for evaluating:
(a) Any variation of more than plus or minus
10 percent in the weight of the capsules, tablets or any other solid form of a
dosage of the same nonsterile compounded drug product;
(b) The adequacy of mixing to ensure
uniformity and homogeneity of each nonsterile compounded drug
product;
(c) If applicable, the
clarity, completeness and pH of a nonsterile compounded drug product;
(d) If applicable, the even distribution of
coloring agents; and
(e) Any
variation of more than plus or minus 10 percent in the actual yield of a
nonsterile compounded drug product compounded by the pharmacy as compared to
the theoretical yield of the nonsterile compounded drug product.
3. Control procedures to ensure:
(a) If the final nonsterile compounded drug
product is a capsule, that the capsule is properly locked;
(b) If the final nonsterile compounded drug
product is a tablet or any other solid form of dosage, that the final
compounded drug product is of a uniform size and is intact;
(c) If the final nonsterile compounded drug
product is a suppository, that the suppository is properly sealed;
(d) If the final nonsterile compounded drug
product is an oral liquid, that, to the extent possible, the liquid is
palatable to the patient;
(e) If
the final nonsterile compounded drug product is a suspension, that the visible
suspended particles are of uniform size and are readily dispersed upon shaking;
and
(f) If the final nonsterile
compounded drug product is a topical compounded drug product, that the final
compounded drug product is smooth and not gritty and has a uniform viscosity
unless grittiness is required for a particular therapeutic purpose.
Added to NAC by Bd. of
Pharmacy by R035-06, eff. 9-18-2008
NRS
639.070
