12/3/2023 0 Comments Lidocaine swish and swallow dosage![]() USP chapter governs compounding activities involving radiopharmaceuticals. It is incorporated into revised USP chapters and that became effective November 1, 2023, and therefore applies to compounding activities involving hazardous drug products after that date: USP General Chapter USP chapter governs the handling of hazardous substances. USP chapter governs compounded sterile drug product preparation: USP General Chapter USP chapter governs non-sterile compounded drug product preparation: USP General Chapter Both the federal DQSA and North Carolina Board of Pharmacy rule incorporate applicable USP chapter standards governing the preparation of non-sterile and sterile compounded drug products. Q: Do United States Pharmacopeia (“USP”) chapter standards apply to drug product compounding as a matter of law?Ī: Yes. Such pharmacies must report (both on an initial permit application and as part of each annual renewal): (1) whether they compound (2) whether the pharmacy engages in non-sterile compounding and (3) whether the pharmacy engages in sterile compounding. How should this be reported to the Board and what information should be provided?Ī: Pharmacies that hold a permit from the North Carolina Board of Pharmacy and that engage in any type of compounding are required to notify the Board. Included in the resources at this link is FDA’s final Guidance for Industry #256, Compounding Animal Drugs from Bulk Drug Substances. The FDA’s most current statement of regulatory policy governing veterinary compounding may be found here: FDA Regulation of Animal Drugs. The federal Drug Quality and Security Act speaks to compounding of human drug products. Q: Does the federal Drug Quality and Security Act prohibit a pharmacy from compounding veterinary drugs for “office use”?Ī: No. The basic contours of the DQSA are discussed in a two-part article published by the National Association of Boards of Pharmacy titled “The Drug Quality and Security Act: What Does It Mean for Compounding Pharmacies?” Part 1 and Part 2. The Food and Drug Administration maintains comprehensive guidance on the DQSA’s provisions, associated guidance documents, and FDA policies here: FDA Human Drug Compounding Resource Page Q: What federal law governs the preparation of compounded drug products?Ī: The Drug Quality and Security Act of 2013 (“DQSA”) broadly governs the compounding of drug products by pharmacies. Compounding is also governed by the federal Drug Quality and Security Act and by applicable United States Pharmacopeia chapter standards, which are incorporated as a matter of federal and state law. ![]() ![]() 2801 governs the preparation of compounded drug products. Q: Which Board rules specifically govern the preparation of compounded drug products?Ī: Board Rule. Statutes, Rules, and Standards Governing Compounding
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