Section 639.67035 - Establishment of policies and proceduresA 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.Nev. Admin. Code § 639.67035
Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008