Some important updates regarding quality standards and changes to the United States Pharmacopeia (USP) standards are coming that may impact your practice.
To give some background, pharmacies in the Revelation Pharma Network follow standard operating procedures that are built around processes developed by USP. While USP is not a regulatory agency and does not carry the force of law, many state boards of pharmacy as well as the FDA recognize USP’s compounding standards as the measure of quality assurance that a compounding pharmacy should follow.
On November 1, 2023, new editions of USP chapters pertaining to nonsterile, sterile, and hazardous drug compounding will become compendially applicable, meaning that they are the most current versions and regulatory agencies may choose to adopt them.
It is important to note that these new editions are not simple modifications but are largely complete re-writes of the current chapters and represent significant changes to some areas of compounding, some of which could potentially affect the way you are able to prescribe compounded medication.
Some key changes include:
- More restrictive beyond-use dates
- Increased stability testing of compounded preparations
- Limitations on batch sizes
Revelation is committed to the highest quality standards and maintaining access to the compounded preparations you and your patients rely on. We are diligently working with state boards of pharmacy to gauge their expectations for USP adoption and timing our modifications appropriately. We recommend that you:
- Review the updated USP guidelines and consider how they may affect your practice, and
- Consult with the pharmacy you prescribe with to see if changes affect the state you practice in.
Here are some suggested resources:
