Posted: 02 Nov 2016 07:04 PM PDT
By James E. Valentine & Karla L. Palmer –
There are a number of lists that are central to FDA’s regulatory framework for the regulation of pharmacy compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetics Act (FD&C Act). In recent posts, we’ve discussed additions to one such list: the list of drugs that may not be compounded under 503A and 503B (see posts here and here).
FDA’s Pharmacy Compounding Advisory Committee (PCAC) is meeting to consider substances nominated for inclusion on two other lists:
Substances Nominated for Inclusion on the 503A Bulks List
One of the conditions that must be met for a compounded drug product to qualify for the exemptions in section 503A is that a licensed pharmacist or licensed physician compounds the drug product using bulk substances that meet one of the following criteria:
Before developing the 503A Bulks List, FDA must convene and consult an advisory committee on compound unless it determines that the issuance of such regulation before consultation with an advisory committee is necessary to protect the public health (seeFD&C Act § 503A(c)(1)). FDA is doing just that at the November 3rd PCAC meeting. The full nomination process is discussed in FDA’s Interim Policy that was published in June.
As discussed at the February 2015 PCAC meeting, in the July 2014 Federal Register notice (79 Fed. Reg. 37,747, 37,748)soliciting (re)nominations for the section 503A Bulks List, FDA proposed the following criteria to evaluate the nominated substances:
Today, FDA is presenting to the PCAC results of its review of some of the nominated substances to obtain the Committee’s advice on whether to include the substances on the list. Specifically, the substances being discussed at this meeting are:
Both sections 503A and 503B also prohibit compounding of drugs that are on FDA’s Difficult to Compound List. One of the conditions for the exemptions under section 503A is that the compounded drug product is not a drug product that “presents demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product” (see FD&C Act § 503A(b)(3)).
Similarly, one of the conditions for the exemptions under section 503B is that the compounded drug product “is not identified (directly or as part of a category of drugs) on a list published by the Secretary . . . of drugs or categories of drugs that present demonstrable difficulties for compounding that are reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug or category of drugs, taking into account the risks and benefits to patients,” or “is compounded in accordance with all applicable conditions identified…as conditions that are necessary to prevent the drug or category of drugs from presenting [such] demonstrable difficulties” (see FD&C Act § 503B(a)(6)).
FDA solicited nominations for the Difficult to Compound List in its December 2013 Federal Register notice (78 Fed. Reg. 72,840). For today’s PCAC meeting, FDA considered a drug product that was nominated for the list, and is proposing the following to the advisory committee:
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