USP Proposed Revisions to Chapter 795 on Non-sterile Compounding
The CVMA is concerned about proposed revisions to Chapter 795 by the U.S. Pharmacopeial Convention (USP) regarding regulations on non-sterile compounding. The proposed revisions include comprehensive requirements that would apply to both compounding pharmacies and veterinary practices. The proposal is written predominately for compounding pharmacies and would be highly problematic for veterinary practices in California and throughout the country.
The USP* is a nonprofit organization that publishes standards for both human and animal drugs annually. It develops standards for compounding nonsterile drugs to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing. USP Chapter 795 provides standards for compounding quality nonsterile preparations. The chapter describes requirements for the compounding process, facilities, equipment, components, documentation, quality controls and training. It also provides general guidelines for assigning beyond-use dates to nonsterile preparations.
In the revision of Chapter 795, intended for publication in 2019, the USP has proposed significant changes that include:
- Eliminating classifications of non-sterile compounding which are utilized in pending California regulations regarding veterinary compounding;
- Subjecting veterinary practices to rigorous building specifications;
- Implementing facility cleaning protocols that will be difficult to fulfill;
- Creating rules that would make compounding in the field (such as in large animal ambulatory medicine) unachievable;
- Instituting staff training requirements that may be inapplicable to small practices;
- Requiring temperature monitoring and recording devices in compounding areas;
- Mandating spill kit and clean up protocols which may be excessive for the nature and scope of non-sterile compounding that occurs in veterinary practices;
- Defining Beyond Use Date (“expiration date”) criteria which could be problematic for veterinary practices and others.
The CVMA believes the revision will not only create problems for veterinarians who perform a limited scope of non-sterile compounding in-house in order to meet the needs of animal patients but will also cause confusion with California Veterinary Medical Board (VMB) regulations. The VMB approved new veterinary compounding regulations in 2017 which differ significantly from the USP 795 draft.
The CVMA has participated in a number of conference calls with representatives from USP and the AVMA Governmental Relations Division regarding the revisions and issues it will create in veterinary practice. The CVMA submitted extensive written comments outlining specific concerns to USP in the open comment period which ends July 31, 2018.
USP representatives have been receptive to comments and are willing to continue to work with representatives from the veterinary profession.
To view the draft USP 795 chapter or to submit comments, go to: http://www.usp.org/compounding/general-chapter-795
To read CVMA’s comment letter on USP 795, click here.
*USP standards are published in combination with the National Drug Formulary (NF), which is a compendium of drug information. Drugs that do not meet USP standards for quality, strength and purity cannot bare the USP-NF monograph and are thus considered adulterated by the Food and Drug Administration (FDA) and other enforcement authorities. Therefore, failure to comply with USP standards may result in enforcement action by one or regulatory agencies.
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