Compounding plays a critical role in treating and preventing disease when commercially available medicine is unsuitable. Traditional compounding involves preparing or mixing a drug to benefit a patient with a unique or specific need. Consider a pediatric patient: a commercially available tablet may only come in doses too high for a child to ingest. In this example, a compounded oral suspension would need to be prepared for the child.
USP’s Compounding Role
The U.S. Pharmacopeial Convention (USP) is a nongovernment, nonprofit, scientific organization that works to advance public health by setting standards for the identity, strength, quality and purity of medicines, food ingredients, and dietary supplements. USP’s quality standards for medicines are mandatory in the U.S. and enforceable by the U.S. FDA.
USP has developed standards for compounding practitioners since 1820, and presently provides three standards types affecting compounding:
- Monographs for bulk substances used in compounded preparations
- General Chapters describing practice and quality standards for compounding
- Compounded preparation monographs containing formulations for specific preparations.
Compounding Standards Development
USP’s Council of Experts and Expert Committees are responsible for developing and revising USP standards. USP Expert Committees are elected on a 5-year cycle, with the new cycle just starting on July 1, 2015. In the 2015-2020 Cycle, there are 24 Expert Committees, one of which is the newly formed Compounding Expert Committee, chaired by Gigi Davidson, BSPh, DICVP, Director of Clinical Pharmacy Services at North Carolina State College of Veterinary Medicine. The 18-member Compounding Expert Committee represents expertise across all compounding areas, including sterile and nonsterile compounding.
When the Expert Committee develops or revises a standard, public comments are solicited through the Pharmacopeial Forum (PF). PF is a free bimonthly online journal where stakeholders can review and comment on proposed standards. The typical public comment period is 90 days, but may be extended in some cases for high impact standards. The Expert Committee collects and reviews all public comments and determines whether the proposal should proceed based on the nature and significance of the comments received. The proposal may be forwarded and balloted by the Expert Committee, or it may be deferred and forwarded at a later date or reproposed in PF. If approved by the Expert Committee through balloting, the proposal will be published in the next USP-NF or Supplement. The USP-NF and its Supplements become official six months after being published. However, this period may be extended based on the public comments and the Expert Committee’s recommendations.
Once a standard is published in the USP-NF, a summary of comments received and the Expert Committee’s response is posted in the Revision and Commentary section of the USP website. The commentary is not part of the official text and is intended to explain the Expert Committee’s response to public comments on proposed revisions.
Jeanne Sun, Pharm.D., is an Associate Scientific Liaison in the Healthcare Quality Standards department at USP.