|
"We don't consider dietary supplement monographs to be the kind of monographs that they [legislators] were referencing in the statute as being OK to compound," Jane Axelrad said.
"MS. AXELRAD: If there is not a USP monograph, not a dietary supplement monograph, then we do not consider it to meet the standard for a bulk drug substance that can be used in compounding unless it's on this list. It basically says compound with the standards of an applicable USP or National Formulary monograph, and we consider that to be the regular monographs that are used to support or address the standards for drugs, bulk active pharmaceutical ingredients, and finished drug products in that part of the USP, not the dietary supplement monographs and not the compounding monographs either. Those are not what we view as applicable monographs for this.1"
1 Transcript of FDA Pharmacy Compounding Advisory Committee Meeting, June 17, 2015, Afternoon Session, pages 132-134. Accessed at:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/
PharmacyCompoundingAdvisoryCommittee/UCM458513.pdf
It appears that FDA is making their own rules to fit their own agenda. Upon what basis are they relying to "break the law," snub Congress, and to disregard accepted legal USP standards? Let's look at what the legal documents say.
This 2-part series will look at the laws and standards related to compounding and the source of ingredients. We will look at the:
- Drug Quality and Security Act
- FDA Guidance: Pharmacy Compounding of Human Drug Products Under Section 503A of the FFDCA; "Conditions of Section 503A", Item 6
- USP General Notices and Requirements, and
- USP Drug monographs and compares those of active drugs with USP Dietary Supplements
Drug Quality and Security Act
Sec. 503B. Outsourcing Facilities; (a) (2) (B) if an applicable monograph exists under the United States Pharmacopeia, the National Formulary, or another compendium or pharmacopeia recognized by the Secretary for purposes of this paragraph, the bulk drug substances each comply with the monograph;
FDA Guidance on Section 503A (Pharmacy Compounding)
A. Conditions of Section 503A; (6) The drug product is compounded using ingredients (other than bulk drug substances) that comply with the standards of an applicable USP or NF monograph, if one exists, and the USP chapters on pharmacy compounding (section 503A(b)(1)(B) of the FD&C Act).
USP General Notices and Requirements (Excerpts)
"Requirements stated in these General Notices apply to all articles recognized in the USP and NF (the "compendia") and to all general chapters unless specifically stated otherwise."
"Official text is text contained in USP and NF, including monographs, general chapters, and these General Notices."
"An official article is an article that is recognized in USP or NF. An article is deemed to be recognized and included in a compendium when a monograph for the article is published in the compendium and an official date is generally or specifically assigned to the monograph."
"Official articles include both official substances and official products. An official substance is a drug substance, excipient, dietary ingredient, or other ingredient, or component of a finished device for which the monograph title includes no indication of the nature of the finished form."
"An official product is a drug product, dietary supplement, compounded preparation, or finished device for which a monograph is provided."
"Enforcement of USP standards is the responsibility of FDA and other government authorities in the U.S. and elsewhere. USP has no role in enforcement."
"Unless specifically exempted elsewhere in a compendium, the identity, strength, quality, and purity of an article are determined by the official tests, procedures, and acceptance criteria, whether incorporated in the monograph itself, in the General Notices, or in the applicable general chapters."
"Official substances are prepared according to recognized principles of good manufacturing practice and from ingredients complying with specifications designed to ensure that the resultant substances meet the requirements of the compendial monographs."
"The applicable USP or NF standard applies to any article marketed in the United States that (1) is recognized in the compendium and (2) is intended or labeled for use as a drug or as an ingredient in a drug."
An article recognized in USP or NF shall comply with the compendial standards if the article is a medical device, component intended for a medical device, dietary supplement, dietary ingredient, or other ingredient that is intended for incorporation into a dietary supplement, and is labeled as conforming to the USP or NF."
Editor's Comments: According to the document contents printed here, the FDA should enforce what is very clear. There appears to be NO BASIS for a decision to disallow compounding with dietary supplements!
USP Monographs Comparison
The monograph comparisons will be presented in next week's newsletter showing that the monograph requirements are basically the same, regardless of their placement in the USP/NF.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
| 
