FDA Proposes Electronic Registration for All Manufacturers and Drugs - Pharmaceutical Technology

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FDA Proposes Electronic Registration for All Manufacturers and Drugs
A new system would enhance enforcement, promote access to drug information, and help identify illegal drug manufacturing.

Pharmaceutical Technology

Unclear authority

CMS payment curbs may have a bigger impact on compounders than FDA warnings, which compounders often contest or ignore. Agency efforts to compel large compounders to comply with GMPs and other regulations have been thwarted for years by conflicting laws and overlapping federal and state jurisdictions. Congress sought to clarify FDA's authority over compounding by adding language to the FDA Modernization Act of 1997 (FDAMA) that defined and set standards for legal pharmacy formulating. A provision prohibiting advertising of compounded products, however, opened the door to a legal challenge, and the Supreme Court ruled in 2002 that the entire FDAMA compounding provision was invalid because of its unconstitutional restriction on commercial speech.

FDA responded with a Compliance Policy Guide in May 2002 to clarify which compounder actions warrant enforcement action. Those actions include:

  • distributing inordinate amounts of compounded products out of state;
  • using unapproved bulk active ingredients that fail to meet official compendial requirements;
  • using commercial-scale manufacturing or testing equipment;
  • producing drug products that are essentially copies of commercially available FDA-approved products;
  • producing drug products for third-party sale or wholesale distribution.

At a hearing in October 2003 before the Senate Committee on Health, Education, Labor, and Pensions, Galson of CDER described FDA's efforts to find the "right mix" between FDA and state regulation of drug compounding. He cited FDA's growing concern about large-scale drug manufacturing in the guise of pharmacy compounding and about insufficient controls on equipment and facilities to ensure product quality, particularly for difficult-to-compound sterile and modified-release drugs. Some drugs are compounded "for economic reasons rather than genuine medical need," he noted, expressing concern about the promotion of compounded products as "better" than available commercial therapies.

Meanwhile, the legal battle over compounder regulation continues. In the Wedgwood Village Pharmacy case three years ago, a New Jersey state court affirmed that FDA can inspect and regulate compounders. A recent ruling from a US District Court in Texas, however, (Aug. 30, 2006, Medical Center Pharmacy et al. v. Gonzalez) provides strong support for compounders' claim that their activities are legal and exempt from FDA regulation. If FDA wants to inspect a compounder, it first must prove that the pharmacy does not qualify for the compounding exemption, according to the Texas judge, who notes that compounding serves a clear public interest if it complies with local laws.

This ruling could encourage Congress to craft new legislation to clarify FDA authority to regulate high-volume compounding as part of next year's user fee renewal campaign. Such a move would be supported by patient groups such as the Allergy and Asthma Network Mothers of Asthmatics and the Consumer Health Alliance for Safe Medication (CHASM), which have pressed for tighter controls on compounding by Congress and FDA. In a petition filed with FDA in March 2005, CHASM (which acknowledges support from pharmaceutical manufacturers) requested that all compounded drug products carry labels stating that they are not regulated by FDA and have not been tested for safety, efficacy, or sterility.

Compounding pharmacists counter that such proposals reflect efforts by drug manufacturers to kill off competition. The International Academy of Compounding Pharmacists (Sugar Land, TX, http://www.iacprx.org/) claims that only states have jurisdiction over compounding and that their operations are legal if they fill valid prescriptions, no matter how high the volume or whether products cross state lines.

Although FDA would deny the pharmacy exemption to compounding "for commercial distribution," the new e-registration rule avoids addressing drug compounding issues directly. A more efficient and rigorous FDA drug-registration system linked to NDC codes, however, aims to identify illegal manufacturers better and, in the process, would clarify further those compounding operations that produce misbranded drugs. And, a more efficient and accurate listing process would free FDA resources to focus more on compliance and make it more difficult for large-scale compounders to slip through the cracks. Such possibilities are sure to draw lots of public comment.

Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634,


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