Compliance to USP 797:
Compliance to USP 797 regarding Pharmacy Compounding is always an important issue for all compounding pharmacies to address as quickly as possible. HCC reported to all specialty compounding pharmacies last year that actions proposed by the Michigan legislature may have been just the beginning of things to come. Directly related to the 2012 meningitis outbreak that has been linked to the now defunct New England Compounding Center (NECC), many states now are considering legislation for additional compliance regulations for compounding pharmacies that even include increased criminal penalties for many violations.
To help our clients and anyone involved in a Pharmacy Compounding business, HCC would like to share the following Risk Level Assessment guide that recently was published in the United States Pharmacopoeia—National Formulary (USP-NF) entitled “USP Tests and Assays Chapter 797, Pharmaceutical Compounding, Sterile Preparations.” This deals with new requirements for the compounding, preparation, and labeling of sterile drug preparations and applies to health care institutions, pharmacies, physician practices, and other facilities that prepare or compound sterile preparations.
|Pharmacy Compounding–USP <797> Risk Level Assessment|
|Risk Category||Requirements, Guidance & Examples|
|Low-Risk Level with <12 Hour Beyond Use Date||
Various studies to date have shown that many compounding pharmacies have been slow to react to the guidelines of US797 regarding compliance. The most often cited reasons include:
– Leadership’s lack of knowledge &/or support
– Financial and budgetary restrictions
– Physical plant limitations
– Lack of available training & competency resources
– Time required to implement changes
If you are a compounding pharmacy, the time to get into compliance is now! Do not let small issues with regulatory compliance turn into serious threats to YOUR pharmacy. Be pro-active regarding the requirements to the USP 797 guidelines. Healthcare Consultants has been helping pharmacies since 1989. Let us help you ensure that your compounding pharmacy has no issues by contacting us today for a complete Compliance Review. Reach us online or call today at 800-642-1652.