Pharmacy Compounding: Federal Law in Brief

by Jonathan J. Darrow

Until recently, most ordinary people had never heard of “pharmacy compounding.”  Then, a number of deaths and illnesses caused by a drug that was compounded in a Framingham, Massachusetts pharmacy propelled drug compounding to the national spotlight (see, e.g., Denise Grady et al., Scant Oversight of Drug Maker in Fatal Meningitis Outbreak, N.Y. Times, Oct. 6, 2012).

Compounding is the practice of preparing a drug for an individual patient’s needs, and is used when those needs cannot be met by a mass-produced drug.  See Thompson v. Western States Medical Center, 535 U.S. 357, 360 (2002).  For example, if a patient is allergic to a particular excipient (inactive ingredient) in an FDA-approved medicine, a doctor may order a special compounding pharmacy to prepare the medicine without that excipient. Because of the very small scale of compounding, Congress in 1997 attempted to exempt (via 21 U.S.C. § 353a) the industry from a number of provisions of the Food Drug and Cosmetic Act, including the requirement to submit a new drug application prior to interstate sale (21 U.S.C. § 355), the requirement that the drug labeling bear “adequate directions for use” (21 U.S.C. § 352(f)(1)), and the need to strictly follow good manufacturing practices, or GMP (see 21 U.S.C. § 351(a)(2)(B)).  A number of controls on compounding were included, however, such as the requirement that there be a valid prescription from a licensed practitioner (21 U.S.C. § 353a(a)(1)), that the drug be compounded by a licensed pharmacist (or physician) (21 U.S.C. § 353a(a)(1)), and that the drug be compounded from ingredients that meet certain quality standards (21 U.S.C. § 353a(b)(1)(A)–(B)).

However, § 353a—and with it, all of the provisions and exemptions just mentioned—was held unconstitutional in its entirety in Western States Medical Center v. Shalala, 238 F.3d 1090 (9th Cir. 2001), aff’d 535 U.S. 357 (2002), on the basis of certain restrictions on free speech that were also contained within the statute and which, according to the Ninth Circuit, could not be severed from the remaining provisions because “Congress intended to exempt compounding from the FDCA’s requirements only in return for a prohibition on promotion of specific compounded drugs.” See 535 U.S. at 366. Thereafter, the FDA promulgated a policy by which it would primarily “defer to state authorities regarding less significant violations” but would enforce a number of provisions relating to ingredient standards, unapproved substances, commercial scale production, adulteration, and promotion.  The FDA made clear that its enforcement activities “need not be limited to” these or any particular areas, however, thus negating any expectations that Congress’ now-invalidated exemptions might nevertheless provide a safe harbor through the weight of influence, if not law. Since then, the FDA has in fact exercised oversight of compounding pharmacies, as is evident from the handfuls of warning letters that it sends to non-compliant facilities each year.  These letters have addressed, for example, promotion that made unsubstantiated efficacy claims, contamination, and the large-scale manufacture of what were essentially copies of FDA-approved drugs.

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Call for Applications: Summer Ethics Fellowships at Auschwitz for the Study of Professional Ethics

The Fellowships at Auschwitz for the Study of Professional Ethics (FASPE) uses a unique historical lens to engage law students in an intensive course of study focused on contemporary legal ethics.  FASPE Fellows are granted an all-expenses paid 12-day trip to Germany and Poland to learn about the roles played by legal practitioners — lawyers and judges — in Nazi Germany, underscoring the reality that moral codes governing the legal profession can break down or be distorted with devastating consequences.  This historical perspective then becomes a launching point for discussions about ethical dilemmas facing lawyers in American today.  The program integrates historical, cultural, philosophical, and literary sources; survivor testimony; and on-site workshops in Berlin, Auschwitz, and Nuremberg.

FASPE Law was initially developed with the assistance of Professor Tony Kronman, former Dean of Yale Law School and other Yale Law School faculty members.  Since piloting the program in 2009, 43 Fellows have participated from law schools including Berkeley, Columbia, Georgetown, Harvard, Northwestern, the University of Arizona and Yale. The summer 2013 program will include 12-15 new Fellows chosen through a national application process.  The lead instructor for the 2013 program will be Eric Muller, the Dan K. Moore Distinguished Professor in Jurisprudence and Ethics at UNC School of Law. The Fellowships include all costs associated with the 12-day program, including international and European travel, lodging, and food.

FASPE Law Fellows examine such topics as:

  • Ethical approaches to truth and disclosure in the adversarial process.
  • The ethical challenges of ambition in professional development.
  • Ethics and government lawyering.
  • The Nuremberg Trials and post-war justice, in historic and modern contexts.
  • Ethics in the day-to-day practice of law.

The Fellows are provided with reading materials prior to meeting in New York; and the academic component of the program is intensive and interactive.  Daily Seminars are led by faculty and local experts who engage the Fellows in legal issues associated with the locations visited.

The tentative program dates for FASPE Law are May 26 – June 6, 2013.

Completed applications must be received by January 11, 2013.  Candidates of all religious, ethnic, and cultural backgrounds are encouraged to apply. To apply or to learn more about FASPE, please visit:  http://www.FASPE.info If you have any questions, please contact Thorin Tritter, Managing Director of FASPE, at ttritter@FASPE.info.

The Evolution of Public Health Law Research

By: Scott Burris, JD

Law has been used to protect and promote public health from the early days of European colonization of North America. Quarantine statutes and orders are reported from the mid-17th century. The 1793 yellow fever epidemic in Philadelphia, where our office is based, inspired the federal government’s first public health statute, authorizing relocation of the capital in the event of an outbreak.

By the mid-19th century, sanitarians like Boston’s own Lemuel Shattuck were articulating the idea that a considerable proportion of death and illness was preventable, and arguing that it was moral, feasible, and economical for the state to do the preventing. Law was a primary tool for prevention, and throughout the 19th century, and into the early twentieth, the extent and limitations of federal, state and local public health authority was litigated, debated in legislatures and defined in voluminous treatises by scholars like Freund, Tiedeman and Tobey.

And then, it got quiet.

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