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Note: Next week, we will resume our series on "Implementing United States Pharmacopeia (USP) <800>; Hazardous Drugs-Handling in Healthcare Settings.".
This week, we will discuss the role of the United States Pharmacopeial Convention, Inc. (USP) in setting official professional practice standards for pharmacy, medicine, nursing, etc. We have been presenting this information for several weeks in this weekly newsletter.
So far we have presented the following:
- USP standards must be science-based.
- USP professional practice standards chapters are based predominantly on "Opinion" rather than on "Science" and "Scientific studies."
- The purpose of the USP General Chapters is to centralize information relevant to several substance and product monographs.
- The USP is recognized as official for its standards for substances and products/preparations.
- FDAMA97 and DQSA recognize the USP standards for ingredients used in compounding.
- There appears to be no authorization in the 1906 Federal Food and Drugs Act, FDAMA97, or DQSA concerning the USP developing professional practice standards for pharmacy, medicine, nursing, etc.
- USP Chapters <795>, <797>, <800>, and others were simply "inserted" into the USP in an inappropriate place, as they are not congressionally authorized as official or designed to be in the USP.
Authority for Establishing Professional Practice Standards
The USP does not appear to have been granted the authority for establishing "OFFICIAL" professional practice standards for pharmacy, medicine, nursing, etc. The actual authority for establishing professional practice standards generally resides with the individual states, especially the state boards of pharmacy, medicine, nursing, etc. The individual Boards can either prepare the standards, use model standards from other sources (e.g., NABP in the case of pharmacy), or some other entity, etc. In summary, to view the USP professional practice standards published as "official" and "enforceable" does not seem to be appropriate and seems to be without foundation.
I recall back when we wrote the first practice standards at the request of the CEO of USP, Dr. Roger Williams; he explained that he wanted to establish a series of professional practice standards for the USP, including those for nonsterile compounding, sterile compounding, hazardous drugs compounding, etc. After the Pharmacy Compounding Expert Committee wrote USP <795>, the question of "where do we put it in the USP?" was asked. The chapters didn't really "fit" anywhere, but it was decided by USP personnel to insert them in the Physical Tests section of the General Chapters. This was followed by USP <797>, etc.
At the time, the expert committee was given a task by the USP CEO and didn't really consider the question of the authority to do this task. There was a lot of pressure from the FDA, and it was discussed at that time that these chapters may aid in keeping the FDA at bay�but we know that has not been the case.
In summary, it does not seem that there was ever any "legal authority" provided to the USP to establish "official" professional practice standards...it was simply done. If this is the case, they are not "official" and should be removed from the USP, and the responsibility for development of professional practice standards be placed on the state boards of pharmacy.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
NOTE: More SOPs have been added this week on www.CompoundingToday.com.
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