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Following a teleconference with United States Pharmacopeia (USP) staff and attorneys, I received a letter dated July 6, 2016 from USP presenting their reasons for believing that the USP professional practice standards related to compounding are "authoritative and enforceable." USP statements are in regular typeface and this Editor's responses are in boldface.
USP is a science-based nonprofit organization that sets forth public quality standards for medicines.
True, it is a science-based nonprofit organization that sets forth public quality standards for MEDICINES, but not for health professionals (pharmacists, physicians, nurses, etc.). Also, many aspects of the professional practice standards (Chapters <795>, <797>, <800>) are not science-based so they are not appropriate to be included in the United States Pharmacopeia—National Formulary (USP—NF). USP derives its authority to set standards from the USP Convention which is composed of delegates representing the profession of pharmacy, medicine, nursing, and industry. The commitment to ensure public quality standards related to compounding has been reaffirmed a number of times in resolutions passed by the Convention.
USP states that it derives its "authority" from itself (the USP Convention). I don't believe a private organization can give itself authority to establish "legal or authoritative" professional pharmacy practice standards; this is the responsibility of the State Boards of Pharmacy. USP standards, general chapters, and monographs contained in the USP and NF have long been recognized in various provisions of the Federal Food, Drug and Cosmetic Act (FDCA).
True, but for compounding, they have been recognized in the FDCA as standards for ingredients and products/preparations only, not as professional pharmacy practice standards. USP General Chapters are developed by Expert Committees which are composed of experts in the field. These standards are based on evidence when they are available, and based on best practices determined by the expertise of the Expert Committee with input from stakeholders through the public comment process.
USP Expert Committees are generally composed of individuals who volunteer and are selected for various reasons. In decades of service on national committees of many pharmacy organizations and government agencies (including the USP and FDA), it is apparent to me that committees are not always representative of the universe the committee is supposed to represent. As we know, just as "one size does not fit all," "one committee does not represent all." Consequently, there are many practices and areas that are not represented, but patients and pharmacists suffer the fallout from the lack of representation and standards not based on science and scientific studies. There are always "unintended consequences" from the lack of complete representation on committees.
"Evidence and best practices" do not necessarily fit the requirement of item number one above, where "USP is a science-based�." Best practices are not necessarily scientific, are fluid in nature, and are often just opinions; however, the resulting standards are applied to ALL practitioners as law in many states. USP standards for compounding were recognized in the 1997 Food Drug Administration Modernization Act in Section 503A, which states that a compounder must use bulk drug substances and ingredients that "comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding." More recently, Congress enacted the 2013 Drug Quality and Security Act (DQSA) to clarify the FDA's authority over drug compounding and reaffirmed USP's role under Section 503A. The FDA's current thinking is set forth in a published Guidance document which specifically references General Chapters <795> and <797>.
The FDA has misrepresented Section 503A as previously discussed elsewhere. (See the "Postscription" in the Jul/Aug issue of the International Journal of Pharmaceutical Compounding [IJPC]. A free download is available.) The reference to USP is only to the standards for ingredients that must be used as described in the USP <795> section on "Component Selection, Handling, and Storage," not to the entire chapter.
The USP and NF are recognized in state and federal laws and are enforced by regulatory authorities such as the FDA and state boards of pharmacy.
USP standards are required for manufacturers but the use of USP compounding chapters by individual State Boards of Pharmacy is optional and varies from state to state. USP Chapters <795>, <797>, and <800> have been adopted and recognized by regulatory bodies such as the FDA and state boards of pharmacy.
The chapters have not been adopted/incorporated by all the State Boards of Pharmacy.
Please note, everything published either in this newsletter or in IJPC has been documented. For additional comments in the current edition of IJPC, please go to:
http://www.ijpc.com/Sample/Article.cfm?SID=106
http://www.ijpc.com/Sample/Article.cfm?SID=107
Also, there appeared an FDA Law Blog back on December 2, 2013 reporting some of the same concerns. Please read the last sentence in the next to the last paragraph on the blog at:
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/12/surprise-fda-quickly-issues-compounding-draft-guidances.html
In summary, it appears there is nothing granting the USP authorization to establish official/authoritative/enforceable professional practice standards applicable to pharmacy, medicine, nursing, etc.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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