When Congress passed the Drug Quality and Security Act (DQSA) into law in November 2013, it did so with the contention that it would prevent the sort of egregious lapses that allowed a pharmaceutical compounder's products to kill dozens and leave hundreds more wounded in 2012.
Under the status quo, pharmaceutical compounders were regulated largely by state-level regulators, usually state boards of pharmacy. But under the DQSA, compounders could voluntarily subject themselves to a new level of regulation by registering themselves as "outsourcing pharmacies," allowing them to operate across state lines, but in return allowing FDA greater access to their facilities and records.
But, critics asked, if compounders aren't required to register with FDA, how will the law prevent future tragedies?
Simple, legislators responded: The law is effectively a market-based solution. Because FDA-regulated facilities are deemed to be of superior quality, consumers and purchasers of compounded products will seek to buy products from those facilities which are registered. Unregistered facilities are less likely to get business, and will either seek to become registered or will go out of business.
Hamburg's Peer Pressure Approach
But to read a letter sent this week by FDA Commissioner Margaret Hamburg, the agency isn't taking any chances on companies or consumers making this connection implicitly.
In her 8 January 2014 form letter to members of state boards of pharmacy, Hamburg asked that they "encourage compounding pharmacies located outside of your state that ship compounded sterile drugs into your state to register with FDA as outsourcing facilities."
"The registration of pharmacies as outsourcing facilities will help FDA identify and more effectively regulate these facilities," Hamburg added. "If compounders register with FDA as outsourcing facilities, hospitals and other health care providers that purchase compounded drugs necessary to meet the medical needs of their patients can provider their patients with drugs that were compounded in outsourcing facilities, which are subject to [current good manufacturing practice] requirements and increased federal oversight."
Hamburg continued in a letter to hospitals and purchasers: "You can play an important part in improving the quality of compounded drugs by requiring compounding pharmacies that supply drugs to your facility to register as outsourcing facilities. Once they register, you and the patients you serve can be assured that FDA will inspect these facilities on a risk-based schedule, hold them to CGMP requirements, monitor the adverse event reports they are required to submit to the agency, and require appropriate labeling."
"I urge you to consider this in your future purchasing decisions," Hamburg concluded.
The agency apparently hopes that some peer pressure, courtesy of state compounding boards and purchasers, will be enough to start steering pharmacies into the new regulatory regime.
But perhaps the biggest question of all is this: Will consumers appreciate the difference between traditional compounders and federally regulated ones?
Perhaps, but given that of the seven of the 11 compounding facilities registered so far as outsourcing facilities have received notices of deficiency (i.e. FDA Form-483s and/or Warning Letters) in the past year, that's far from an easy question to answer.