Physicians can reduce liability and mitigate the risk of poor-quality drugs by taking advantage of a new federal law that tightens oversight on drug compounding facilities.
The ongoing implementation of the Compounding Quality Act (CQA) of 2013 follows a deadly 2012 meningitis outbreak linked to a steroid from a Framingham, Mass.–based drug compounder. The outbreak killed more than 60 people and sickened hundreds more.
Nathan Brown
"The whole tragedy from the meningitis outbreak was a wakeup call for policy makers, but also for physicians, who in a lot of cases weren’t always focused on whether the drugs they were administering or dispensing were compounded or not," Nathan A. Brown, a partner at Washington-based law firm, said in an interview. "As a result, there is a lot more awareness. Under the new law, there are now opportunities for doctors to ask more questions about the source of the drugs and whether they can be confident and have assurance of whether that drug is going to be of high quality."
The CQA is part of the Drug Quality and Security Act (DQSA) of 2013, which clarifies regulatory control over traditional drug compounding entities. The law also creates a new section under the federal Food, Drug and Cosmetic (FD&C) Act that allows compounders to voluntarily become "outsourcing facilities." As a registered outsourcing facility, compounders making sterile products can sell unlimited quantities of drugs on the Food and Drug Administration’s drug shortage list without a preexisting prescription and avoid new-drug approval requirements under the FD&C Act. However, they must undergo regular FDA inspections and follow the FDA’s Current Good Manufacturing Practice (cGMPs) regulations. Such facilities also must report adverse drug reactions to the FDA, compound under the supervision of only a licensed pharmacist or physician and use drugs from a bulk ingredients list only.
In a January letter, the FDA encouraged hospitals and other health care facility purchasers to use compounders registered as outsourcing facilities.
If facilities choose not to register, they may still be eligible to compound under 503A of the FD&C, which requires, among other rules, that they compound only for an identified, individual patient, based on the receipt of a valid prescription order. If compounders do not register as an outsourcing facility, nor are eligible under 503A, they must follow all of the requirements under the FD&C that are applicable to conventional manufacturers.
For physicians, the new law means the chance to better scrutinize where their drugs originate and to review whether compounders are using proper practices, legal experts said. This could include discussing possible FDA registration with outside compounders or, for hospital physicians, collaborating with administrators about the best source of compounded drugs. The FDA plans to publish registration and inspection data of outsourcing facilities on its website.
"Physicians should feel empowered to ask questions about the sources of their drugs because there’s more information available now, and it’s in their interest and their patients’ interest to make sure they fully understand the source of their drugs and potential risks," Mr. Brown said.
Doctors can also have a voice in what type of drug products compounders are allowed to work with. The FDA is currently accepting nominations for bulk drug substances that it should approve for compounding under 503A and 503B. Nominations for bulk drug substances are open until Sept. 30.
"Physicians and hospitals are going to be in the best position to really identify those types of drugs that are critical to have on hand in hospitals or office settings, and they should be monitoring the implementation process and commenting as appropriate, to make sure the drugs they need are still going to be available through outsourcing facilities or otherwise," Mr. Brown said.
Areas of uncertainty persist in the new law and its provisions. One unanswered question pertains to the purchasing of compounded products for office use, according to Christopher J. Topoleski, director of federal regulatory affairs for the American Society for Health-System Pharmacists during an American Health Lawyers Association webinar. This refers to drugs that physician practices or hospitals store for future use but that are not connected to a specific prescription. The DQSA does not specifically address the term "office use" or define what is acceptable.
"Many stakeholders have stated to the agency that office use is currently governed by state pharmacy laws," Mr. Topoleski said in an interview. "However, given the uncertainty of the FDA position, physicians who use entities that are not registered under 503B to supply office stock of compounded products may not be able to do so in the future."