Dear KMAG: 20210524 Joe Biden Didn’t Win ❀ Open Topic

This tweet was posted yesterday about the FDA regulating supplements:

https://twitter.com/VeritasTXgem/status/1395920671763574784

Seems like they are VERY LATE in sounding the alarm.

Updated July 1, 2020

1 Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act

Includes three categories of bulk drug substances:

• Category 1: Bulk Drug Substances Under Evaluation

• Category 2: Bulk Drug Substances that Raise Significant Safety Concerns

• Category 3: Bulk Drug Substances Nominated Without Adequate Support Updates to Section 503A Categories

• Removal from category 3 o Artesunate – This bulk drug substance is a component of an FDA-approved drug product (NDA 213036) and compounded drug products containing this substance may be eligible for the exemptions under section 503A of the FD&C Act pursuant to section 503A(b)(1)(A)(i)(II). This change will be effective immediately and will not have a waiting period. For more information, please see the Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A and the final rule on bulk drug substances that can be used for compounding under section 503A, which became effective on March 21, 2019.

https://www.fda.gov/media/94155/download

Note there are THREE DIFFERENT LISTS!

>>>>>>>>>>>>>>>

NEXT STOP FEDERAL REGISTER

This is very important. If We the People do not scream bloody murder a proposed rule then becomes law.

List of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act
A Rule by the Food and Drug Administration on 02/19/2019

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA or the Agency) is issuing a final rule to establish criteria for and identify an initial list of bulk drug substances that can be used to compound drug products in accordance with certain compounding provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), although they are neither the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drugs. Specifically, the Agency is placing six bulk drug substances on the list. This final rule also identifies four bulk drug substances that FDA has considered and is not including on the list. Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of a future rulemaking.

DATES:

This rule is effective March 21, 2019.

.

.

.

B. Summary of Comments to the Proposed Rule

We received eight substantively relevant, unique comments to the 2016 proposed rule. The comments addressed FDA’s proposals on the criteria for evaluating bulk drug substances for inclusion on the 503A Bulks List, including some comments on how FDA has been using the criteria in practice. The comments also addressed FDA’s proposals on particular bulk drug substances. In addition to these topics, which addressed the language proposed to be included in the Code of Federal Regulations (CFR), commenters addressed a variety of topics related to FDA’s evaluation of bulk drug substances, including procedural issues related to meetings of the PCAC, and compounding policies generally….

So they looked at some of these materials all the way back in 2016.

>>>>>>>>>>>>>>>>

Last the actual law they are about to shove these compounds under so they can regulate them

Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry

II. BACKGROUND

A. Section 503A of the FD&C Act Section 503A, added to the FD&C Act by the Food and Drug Administration Modernization Act of 1997 and amended by the Drug Quality and Security Act in 2013, describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist in a State licensed pharmacy or Federal facility, or by a licensed physician, to qualify for exemptions from the following three sections of the FD&C Act:^3

 Section 501(a)(2)(B) (concerning current good manufacturing practice (CGMP) requirements)

 Section 502(f)(1) (concerning the labeling of drugs with adequate directions for use)

 Section 505 (concerning the approval of drugs under new drug applications (NDAs) or abbreviated new drug applications (ANDAs))

One of the conditions that must be met for a compounded drug product to qualify for the exemptions under section 503A of the FD&C Act is that it must be compounded by a licensed pharmacist or a licensed physician that “does not compound regularly or in inordinate amounts (as defined by the Secretary) any drug products that are essentially copies of a commercially available drug product.”4 The statute further states that “the term ‘essentially a copy of a commercially available drug product’ does not include a drug product in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug.”5 A complete list of the conditions that must be met for a compounded drug product to qualify for the exemptions in section 503A appears in the FDA guidance, Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act…..

>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>

Finally going back to the Federal Register there is this information:

(Comment 20) One comment objected to the rejection of substances that are dietary supplements from the 503A Bulks List. The commenter states that by rejecting these substances from the list, FDA is forcing consumers to use products that are subject to less quality oversight and lack physician supervision. The commenter proposes that dietary supplements only be rejected for proven safety concerns.

(Response 20) As stated in Response 16, a substance’s availability as a dietary ingredient or supplement is not a criterion when evaluating a substance for inclusion on the 503A Bulks List. Dietary supplements are intended for oral ingestion only, and are not intended to be used to treat diseases, and therefore, are subject to a different legal and regulatory scheme than drug products. Section 503A of the FD&C Act addresses compounded drug products only. To the extent FDA’s reviews and PCAC meetings included discussions about the availability of dietary supplements with dietary ingredients that were the same or similar to the nominated bulk drug substances, we note that FDA’s proposals in this context do not impact a substance’s availability as a dietary supplement.

Regarding the comment about the lack of quality oversight for dietary supplements, we note that dietary supplement manufacturers are required to comply with FDA’s Current Good Manufacturing Practice regulations for dietary substances and are subject to inspection by FDA (21 CFR part 111). Regarding physician supervision, we note that physicians may recommend dietary supplements to their patients regardless of whether the substance appears on the 503A Bulks List.

So it looks like a bit of confusion reigned and this ruling does not impact dietary supplements. Not surprising since it is tough to untangle some of this stuff.