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FDA Exerts New Authority over Compounding Pharmacies with Drug Quality and Security Act

Posted in FDA Regulation, Politics, Public Health

In the wake of the recent fungal meningitis outbreak that left 64 dead and infected some 751 Americans, traced back contaminated steroid injections from the New England Compounding Center (Framingham, MA), the United States Food and Drug Administration has sought greater oversight over the pharmacy compounding industry.

To that end, Congress passed the Drug Quality and Security Act (DQSA) on 11/27/2013, a law with two aims: to ensure the quality of compounded drugs, and to ensure the security of compounded drugs.  Toward the goal of ensuring drug quality, the law “Establishes annual registration requirement for any outsourcing facility” (for clarity, “outsourcing facility” means compounding pharmacy), “Requires a facility to report biannually to the Secretary of Health and Human Services (HHS) on what drugs are compounded in the facility and to submit adverse event reports”, and “Subjects such facilities to a risk-based inspection schedule.” (DQSA)

Toward the goal of ensuring drug security, the law “Establishes requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain” (DQSA).  According to an article by FDA Commissioner Dr. Margaret Hamburg, this will be a stepwise process taking ten years to become fully effective.  At that point, the law “will require manufacturers, repackagers, wholesale drug distributors, and dispensers (other than most licensed health care practitioners) to provide product and transaction information with each sale and notify the FDA and other stakeholders of illegitimate products, which will result in improved detection and removal of potentially dangerous drugs from the supply chain.”

Jill Wechsler, Washington editor of the Pharmaceutical Technology blog, PharmaTech Talk, writes that of yet (just three months after the passage of DQSA), only 14 compounding pharmacies have registered with the FDA – of over 3,000 currently operating in the United States.  However, these figures ought not to be discouraging, she writes, as “this initial activity reflects FDA’s fast action in implementing the Drug Quality and Security Act”.

Further, there is a disincentive for compounding pharmacies to register with the FDA including significant fees and the obligation to submit to federal regulations and inspections, and Wechsler writes the FDA is currently implementing three strategies to encourage compounding pharmacy registration.  First, the FDA is asking “hospitals to exert their purchasing power to compel compounders to embrace the new regulatory system” by sending letters to “hospitals urging them to pressure the compounding pharmacies they buy from to sign up as outsourcing facilities. Support for this approach was recently voiced by executives at the Premier hospital system, which purchases drugs for hundreds of hospitals.”

Next, Commissioner Hamburg has sent letters to state governors and “members of state boards of pharmacy and state health officials” touting the benefits of the Drug Quality and Security Act, seeking state assistance in “dealing with distant compounders that ship into a state.”

Though there are certain disincentives for compounding pharmacies to register with the FDA, it must be made clear the possibilities of their commercial benefit and legal protection await.

Lastly, the FDA is aiming to encourage compounding pharmacy registration by re-establishing Pharmacy Compounding Advisory Committee, which will make new regulations.  The committee will likely be composed of “leading experts in the field” and “nonvoting representatives of pharmaceutical manufacturers and of pharmacy compounders.”

Wechsler concludes, “One important task for FDA is to develop lists of drugs that may not be compounded and lists of bulk drug substances that comply with established standards and thus may be used in compounding. FDA plans to issue new regulations to update these lists. The agency also will continue proactive and for-cause inspections of compounding pharmacies and will ‘take aggressive action’ when necessary to protect the public health.”

Though I find it incredible that compounding pharmacies had not as yet been subject to federal inspection and other such requirements, DQSA is absolutely a step in the right direction.

 

Jill Wechsler’s article from PharmaTech Talk is available here:

FDA Expands Oversight of Large Compounders

Also, the FDA provides a helpful Frequently Asked Questions page on compounding pharmacies available here:

Compounding and the FDA: Questions and Answers