(Used for Compounding Medications)
In the Newsletter on June 16, we presented a reasonable approach involving verifying standards for filters used to sterilize drug preparations for human use and comparing them with the documents (Certificates of Analysis or other documentation) from the filter companies.
In order to accommodate this activity, there is a new Standard Operating Procedure, SOP No. 6.097 Filter Qualification/Evaluation Procedure available to subscribers on the www.CompoundingToday.comwebsite.
Also, don't forget, you can download free the updated documentation "White Paper: Human-Use Sterilizing Filter Issue," which includes all the responses received from various filter companies during the entire process at the same website.
NEW POSTED USP STATEMENT CLARIFIES RESPONSIBILITY
The USP website now has a new presentation of "USP in U.S. Law" and appears to clarify their responsibility, discussing ingredients and products and not professional standards. It states that the USP develops standards for "Medicines, Food Ingredients, and Dietary Supplements." Under "Medicines," specific drug categories and topics include "Drugs, Biologics, Medical Devices, Compounded Preparations and Nomenclature." Please take time to read this document.
Loyd V. Allen, Jr., PhD, RPh
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition