Section 639.67015 - Establishment of policies and procedures1. A pharmacy engaged in the practice of compounding drug products shall establish and maintain written policies and procedures for compounding 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:(a) Policies and procedures for: (1) The processes used by the pharmacy to compound drug products;(2) The equipment used by the pharmacy to compound drug products;(3) Ensuring that the actual weights and measures of each component are within plus or minus 5 percent of the theoretical weights and measures required for the drug products compounded by the pharmacy;(4) Tracking, recalling and destroying the drug products compounded by the pharmacy, which must include a requirement that the pharmacy ensure that all drug products which could have been compounded with a particular component be located, recalled and destroyed; and(5) Identifying the drug products or components of drug products that will be considered hazardous drugs.(b) Control procedures for monitoring each final compounded drug product and validating the compounding processes that may be responsible for causing variability in the final compounded drug product.(c) Control procedures to ensure that: (1) Each component is accurately weighed, measured or subdivided, as appropriate;(2) Any variation in the actual yield of a drug product compounded by the pharmacy is within plus or minus 10 percent of the theoretical yield of the compounded drug product; and(3) If a component is transferred from its original storage container to a new storage container, the new storage container is labeled with the date of the transfer and information that is sufficient to trace the contents of the new container to the original storage container.2. A member of the staff of the Board may require a pharmacy engaged in the practice of compounding drug products to provide a sample of a drug product that is being compounded at the time of the request and any records related to that compounded drug product for purposes of testing the compounded drug product for compliance with the provisions of NAC 639.661 to 639.690, inclusive. The Board will share the costs of testing such a sample equally with the pharmacy.3. If a sample tested pursuant to subsection 2 does not comply with the provisions of NAC 639.661 to 639.690, inclusive, the Board will notify the pharmacy of the failure to comply and the pharmacy must: (a) Provide to the Board a written plan for remediating or addressing the noncompliance; and(b) If requested by a member of the staff of the Board, provide an additional sample of the compounded drug product for testing. The costs of a test conducted pursuant to this paragraph must be paid solely by the pharmacy.4. If the sample provided to the Board pursuant to paragraph (b) of subsection 3 does not comply with the provisions of NAC 639.661 to 639.690, inclusive, the Board will take such action as it deems necessary to correct the noncompliance or to prevent further noncompliance, including, without limitation: (a) Suspending the license of the pharmacy pursuant to NRS 639.210;(b) Suspending the ability of the pharmacy to compound certain drug products; and(c) Requiring the pharmacy to perform any other remedial or protective measures the Board deems necessary to correct the noncompliance or to prevent further noncompliance.Nev. Admin. Code § 639.67015
Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008