FDA CVM GFI #256 - Compounding Animal Drugs from Bulk Drug Substances

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Draft – Not for Implementation Compounding Animal Drugs from Bulk Drug Substances Guidance for Industry This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA or Agency) current thinking on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance describes the Food and Drug Administration’s (FDA) policy regarding the 1 compounding of animal drugs from bulk drug substances by or under the direct supervision of: • Veterinarians, or • Pharmacists in either State-licensed pharmacies or Federal facilities (i.e., facilities 2 operated by the Federal government). Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the compounding of an animal drug from bulk drug substances results in a “new animal drug” that must comply with the FD&C Act’s approval, conditional approval, or indexing requirements (sections 512, 571, and 572 of the FD&C Act (21 U.S.C. §§ 360b, 360ccc, 360ccc-1)). Further, all animal drugs are required to, among other things, be made in accordance with current good manufacturing practice (cGMP) requirements 1 FDA regulations define “bulk drug substance” and “active pharmaceutical ingredient” as “any substance that is intended for incorporation into a finished drug product and is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.” The terms do not include intermediates used in the synthesis of the substance. 21 CFR 207.1. “Active ingredient” is defined as “any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.” 21 CFR 210.3(b)(7). Any component other than an active ingredient is an “inactive ingredient.” 21 CFR 210.3(b)(8). Inactive ingredients used in compounded drug products commonly include flavorings, dyes, diluents, or other excipients. In addition, for purposes of this guidance, FDA considers bulk chemicals used to make antidotes intended to treat toxicoses in animals to be bulk drug substances. 2 Throughout this guidance, the terms “pharmacists,” “pharmacies,” and “veterinarians” refer to those persons or entities that are State-licensed and operate in full compliance with State laws or regulations governing their practice. 3

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