On December 4, 2013, the FDA began implementing Title I of the Drug Quality and Security Act (DQSA) of 2013 (H.R. 3204), signed into law by President Obama on November 27, 2013. Title I of the DQSA, entitled the Drug Compounding Act, amends the Federal Food, Drug, and Cosmetic Act (FDCA) with respect to the compounding of human drugs, broadening the FDA’s authority to regulate their manufacture. The Drug Compounding Act amendments require numerous FDA actions, including the establishment of registration and reporting requirements for any outsourcing facility and the publication of a list of drugs presenting demonstrable difficulties for compounding.
FDA Guidance Actions
The FDA’s actions include issuing: (1) a draft guidance setting forth an interim electronic submission method for human drug compounders that choose to register as outsourcing facilities; (2) a draft guidance, that when finalized, will represent the FDA’s final position regarding electronic registration of human drug compounders that choose to register as outsourcing facilities; and (3) a draft guidance on the application of the Drug Compounding Act and the agency’s current enforcement policies relating to the compounding of human drug products. Comments on the three draft guidances are due by February 3, 2014.
The FDA has also announced the withdrawal of a guidance entitled “Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act,” which was issued in November 1998, and section 460.200 of the Compliance Program Guidance (CPG) Manual entitled “Pharmacy Compounding,” which was issued in May 2002. Both of these documents are no longer consistent with FDA policy.
FDA List Actions
The FDA’s actions also include a request for candidates to be included in (1) a list of drug products that present demonstrable difficulties for compounding, and (2) a list of bulk drug substances that may be used by outsourcing facilities to compound drug products. The FDA also announced that it is withdrawing a proposed rule to list of bulk drug substances that could be used in compounding, which the agency began to develop in 1998, but that was held unconstitutional in 2002, before the rule could be finalized.
Interim Registration Guidance
The draft interim guidance, entitled “Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act,” describes how an outsourcing facility should provide interim electronic reports while FDA modifies its existing electronic drug registration and listing system to accommodate reporting of product information by registered outsourcing facilities under new section 503B of the FDCA. When the FDA has modified its current electronic submission system to allow outsourcing facilities to submit information electronically through a Structured Product Labeling file, the agency intends to issue another draft guidance describing the updated format for long-term use. When such guidance is issued in final form, it will specify the form of reporting that outsourcing facilities are to follow from that point forward.
The draft registration guidance, entitled “Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act,” addresses new provisions in the FDCA, as added by the Drug Compounding Act, and is intended to assist human drug compounders that choose to register as outsourcing facilities to register electronically with the FDA.
Pharmacy Compounding Guidance
The draft guidance entitled “Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act,” provides information to compounders of human drug products on the FDA’s application of section 503A of the FDCA and current enforcement policies relating to the compounding of human drug products. Among other things, the draft guidance restates the provisions in section 503A that remain in effect after amendment by the Drug Compounding Act, describes FDA’s interim policies with respect to specific provisions in section 503A that require implementing regulations or other actions, and contains a non-exhaustive list of potential enforcement actions against individuals or firms that compound human drug products.
Demonstrable Difficulties List
The Drug Compounding Act removes provisions from section 503A of the FDCA that had been held unconstitutional by the U.S. Supreme Court in 2002. Because these provisions have been removed, the FDA is now reinitiating its efforts to develop a list of drug products that present demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product. In addition, the Drug Compounding Act adds a new section 503B to the FDCA that creates a new category of “outsourcing facilities” and requires that these outsourcing facilities do not compound a drug identified on a list of drugs that present demonstrable difficulties for compounding. In developing this difficult-to-compound list, the FDA is encouraging interested persons to nominate specific drug products or categories of drug products for inclusion on the list and is describing the information that should be provided in support of each nomination. The nominations are requested by March 4, 2014.
Bulk Drug Substances List
One of the conditions of section 503B of the FDCA, as added by the Drug Compounding Act, is that an outsourcing facility may not compound a drug using a bulk drug substance unless the substance appears on a list established by the FDA. As such, The FDA is developing a bulk drug substances list. To identify candidates for this bulk drugs list, interested persons may nominate specific bulk drug substances, and the FDA is describing the information that should be provided in support of each nomination. Candidates for the list must be submitted by March 4, 2014.