In This Section
My local commercial nuclear pharmacy told me that "797 is all about interpretation and how you can best fit it into your practice."
It is true that USP <797> involves some interpretation. Hence, it is not surprising that there may be differences of opinion regarding specific compliance requirements. Individual practitioners should consult with their facility's pharmacy department, administration, state board of pharmacy, and legal counsel. USP <797> and the USP <797> Guidebook to Pharmaceutical Compounding—Sterile Preparations are the definitive source documents and also provide some general guidance for compliance.
Interpretation can seem problematic, especially when there are differences of opinion. For example, an outside consultant or vendor may provide a very strict interpretation (in some cases, to sell more product) whereas a practitioner may have a very liberal interpretation. There may also be differences based on interpretations of the "letter of the law" or the "spirit of the law." Therefore, within any given facility, key personnel (e.g., practitioners, pharmacy department, administration, and legal counsel) should collectively decide on a facility-wide interpretation and response. Deliberations for such decisions should take into account careful reading of the standards themselves, applicable state laws, available opinions of recognized experts, results of inspections, analysis of liability risk, and other factors. Cost should not be the major determinant.