Davidta Brown, PharmD Candidate c/o 2017
The debate on the nature of compounding practice and the extent to which it ought to be regulated has come to the forefront of public attention. Those who regularly follow American news and politics are familiar with the series of events that have led to the present discussion on reforming compounding regulation- mishaps and tragedies draw attention of both the media and the people to a previously overlooked aspect of American society, prompting calls for reform and new legislation. Often, the earnest desire for change today, when a fresh incident demands attention, is forgotten tomorrow. However, sometimes the mistakes of the past lead to lasting reforms, and the meningitis outbreak last Fall may fit this category. The well-publicized lapse in sterile procedures led to hundreds of cases of recurring illness and nearly fifty deaths across the nation. As a result, many believe that increased federal oversight is necessary to prevent future tragedy.
For those who support stronger regulation, an essential feature of the current debate over compounding pharmacy oversight is the gap in surveillance created by the rapid growth of compounding businesses in the last 10 to 20 years. There have always been the small “mom-and-pop” pharmacies that compound formulations one at a time as requested by a specific prescription. On the other end are the major drug manufacturers who mass-produce the one-size-fits-all medications that physicians prescribe. Now a new group has arisen- one that fits neither classification. These are the compounders that were once small businesses, but who now face overwhelming demand and may produce medication in anticipation of a prescription. These compounding pharmacies may also ship their formulations to customers in other states. This creates a level of difficulty since different states often have unique regulations and procedures with regards to training pharmacy inspectors and handling sub-par pharmacy locations.1 The New England Compounding Center (NECC), whose sterile injections were the source of the fungal meningitis outbreak that began in October 2012, was one of these indistinct, neither big nor small entities, and is now receiving close scrutiny.
After evaluating the events that took place at the NECC, the Senate Committee on Health, Education, Labor, and Pensions approved a new bill in late May that would, in theory, close the regulatory gap by defining three distinct types of compounding pharmacies.3 As described by an article in DIA Daily, the bill would allow small compounding pharmacies to continue being regulated by state pharmacy boards and require large drug manufacturers to be regulated by the FDA. A third group, compounding manufacturers, would include compounders that produce sterile products without a prescription and ship across state lines.5 The Pharmaceutical Compounding Quality and Accountability Act, which can be viewed in its entirety at www.help.senate.gove/imo/media/052213_S._959_Compounding_KER13207.pdf, would require said compounding manufacturers to register with the FDA and undergo regular inspections.2
The new act would signify a drastic departure from current federal regulation of compounding pharmacies, which is minimal. At present, the FDA defers regulation of compounders to state pharmacy boards, with federal involvement “anticipated” in the case of a necessary investigation. 7 Any federal oversight that does exist is present in Section 127 of the Federal FDA Modernization Act of 1997, which clarifies pharmacy compounding as a distinct practice, and exempts compounded drugs from some of the misbranding and approval requirements that exist for manufactured medications. 4
Not surprisingly, this proposed legislation has not been welcomed unanimously, though disagreement seems to come from two opposing perspectives. Some, typically Republicans and compounding lobbyists, say that additional federal oversight is not the solution, and that the current system of regulation would have prevented the shipping of tainted drugs from the NECC, if pre-established protocols had been enforced.1
Others argue that the proposed legislation does not do enough to screen compounding manufacturers for safety. For example, the Pharmaceutical Compounding Quality and Accountability Act excludes pharmacies that ship oral formulations and topical products, such as creams and gels. In addition, it has been argued that the bill does not provide a nationally applicable definition of “compounding manufacturer,” which may leave room for intrastate interpretation and interstate confusion.5 Finally, some suggest that if the definition of a compounding manufacturer is limited to compounders that ship drugs between states, there will be a loophole for those that produce massive amounts of medication, but sell exclusively to consumers within their home state. This perspective maintains that large-scale, intrastate compounders carry significant risk of harm if they are not regulated, and that state pharmacy boards may be unable to provide adequate surveillance.2
In addition to the bill proposed by the Senate sub-committee, other solutions have been suggested. One proposition involves the creation of a “Do Not Compound” list of medications, which compounding pharmacies would be completely prevented from producing.2 This idea is generally unpopular, perhaps because it is viewed as an inappropriate and unjustified limitation on the practice of compounding imposed by an authority unfamiliar with the profession.
Another suggestion is to categorize all compounding pharmacies as manufacturers and subject them all to the same federal regulations.5 In the event of an investigation, this method would facilitate the acquisition of company records by the FDA which, at present, sometimes needs a search warrant before such information can be obtained.2 However, opponents of this proposition argue that improved federal access to records and regulatory processes would make state investigations more difficult, thus implying that the regulation of compounding should be a responsibility of the states.
Viewed from both political and historical perspectives, the compounding pharmacy debate is yet another manifestation of the tension between state and federal governments, as well as of the continual evolution in their respective responsibilities. Incidentally, this is not the first time that the question of who ought to regulate compounding pharmacies has been discussed. The 2002 Supreme Court case Thompson v. Western States Medical Center ruled that compounded drugs could be excluded from federal oversight.6 However, current events could allow one to surmise that the old regulations are insufficient.
Originating as local healers concocting treatments on a need-basis, and now serving as a distinct branch in the practice of pharmacy, compounding pharmacy has come a long way to find itself at the present fork in the road. Whether the decision made today is for stricter federal regulation or for increased state surveillance, or even if no decision is made at all and the issue gets dismissed with the passage of time, there is no doubt that public trust in the institution of compounding pharmacy will be sincerely affected. And as pharmacy is a profession built strongly on patient trust, future developments in this debate will doubtlessly be of interest to all those involved in pharmacy practice.
- Associated Press. Oversight scant at specialty pharmacies nationwide: Report. Cbsnews.com. http://www.cbsnews.com/8301-204_162-57579549/oversight-scant-at-specialty-pharmacies-nationwide-report/. Published April 15, 2013. Accessed May 29, 2013.
- DIA. HELP Committee Makes Progress on Draft Compounding Bill. DIA Daily. 2013. http://mailview.bulletinhealthcare.com/mailview.aspx?m=2013051001dia&r=6020914-2eaf. Published May 10, 2013. Accessed May 29, 2013.
- DIA. Senate Panel Advances Compounding-Pharmacy Oversight Bill. DIA Daily. 2013. http://mailview.bulletinhealthcare.com/mailview.aspx?m=2013052301dia&r=6020914-43ba. Published May 23, 2013. Accessed May 29, 2013.
- Lam C. Clemens R, Perkins D, Richmond F, eds. Pharmacy compounding – regulatory issues. http://regulatory.usc.edu/Articles/PharmacyCompounding. Accessed June 26, 2013.
- Sun, L.H. Senate panel approves tighter oversight of compounding pharmacies, but bill is under fire. The Washington Post. 2013. http://www.washingtonpost.com/national/health-science/senate-panel-approves-tighter-oversight-of-compounding-pharmacies-but-bill-under-fire/2013/05/22/21869ac2-c303-11e2-9fe2-6ee52d0eb7c1_story.html. Published May 22, 2013. Accessed May 29, 2013.
- The Oyez Project at IIT Chicago-Kent College of Law. Thompson v. Western States Medical Center. http://www.oyez.org/cases/2000-2009/2001/2001_01_344. Updated April 26, 2013. Accessed May 29, 2013.
- US Food and Drug Administration. Compliance Policy Guidance for FDA Staff and Industry Sec. 460.200 Pharmacy Compounding. Washington, DC: US Food and Drug Administration; 2002. http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm0 74398.htm. Updated January 10, 2010. Accessed June 26, 2013.