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The USP is a science-based nonprofit organization that sets public quality standards for medicines. USP standards have been long recognized in pharmacy compounding and various provisions of the Food, Drug, and Cosmetic act. Whether you’re a veterinarian or a pharmacist, it’s important to have a working knowledge of what the USP’s role is, federal laws surrounding it, and why you should follow their rules.
The Purpose and Effect of the USP in Pharmacies
USP standards for compounding specifically were recognized in the 1997 FDA Modernization Act in Section 503A. This act states that compounding pharmacies must use ingredients that comply with standards of applicable USP monograph or USP chapter on pharmacy compounding. USP standards are recognized in both state and federal laws and are enforced by regulatory authorities such as the FDA and state boards of pharmacy.
Following the USP standards protects compounding pharmacies from liability, protects the safety and health of their patients, and gives the consumer a way to judge quality. If a compounding pharmacy does not comply with USP standards and regulations, you should not prescribe with them.
USP and Federal Law
The 1906 Federal Food and Drugs Act was the first to recognize the USP as official compendia and the act defers to their standards for ingredients and drug products. The Drug Quality and Security Act refers to bulk drug substances and ingredients used in compounding, which is similar to the FDA modernization act of 1997. The Drug Quality and Security Act states that ingredients must comply with USP standards if such standards exist.
Chapters 795, 959, and 800 of the Drug Quality and Security Act set professional practice standards for compounding pharmacies. It is Federal Law that compounding pharmacies comply with these standards. Ask your current pharmacy if they are aware of and follow USP standards. If they don’t, or if they aren’t sure, you may need to consider switching pharmacies.
Why We Need to Follow USP Standards
The USP standards of quality and security are all science-based and researched. To ensure the highest quality products, and the safest treatments for your patients, it’s best to stick with trusted and science-based standards.
The USP also centralizes information about standards for substances and products/preparations and ingredients used in compounding. This allows for a wider base of knowledge and the ability to share innovations across compounding pharmacies. Standardization is the only real way to ensure the safety and efficacy of compounded medications across the nation.
USP standards for handling hazardous drugs (USP 800) will require large changes in practice – all should be preparing for this transition as it is an enforceable standard, meaning that non-compliance will come with consequences like fines, suspension of licenses, or even the closure of a pharmacy.
The USP has been the standard for pharmacy compounding for over 100 years and continues to be the standard for compounding. Knowing USP 795, 797, and now 800 inside and out is crucial for all healthcare professionals that either prescribe or compound medications.
For the protection and continued health of your patients, you should only be using a pharmacy that consciously complies with USP standards. For more information, or for any questions you have about how your pharmacy complies with USP standards, contact EPC today.
