How FDA Implementation of the Compounding Quality Act Affects Compounding Pharmacies
In the wake of the 2012 meningitis outbreak in Framingham, Massachusetts, caused by drugs manufactured by the New England Compounding Center (NECC), the Food and Drug Administration began working with compounding pharmacies and suppliers to ensure more regulation for the compounding process. Many tenets of the ensuing Compounding Quality Act, signed into law in 2013, are safety and quality measures that many reputable, accredited compounding pharmacies and suppliers already comply with or practice every day. Others required more debate and prompted the compounding pharmacy community to weigh in and add to the ongoing dialogue with the FDA over the line between protecting patient safety, which is everyone’s goal, and potentially hampering the industry with over-regulation.1
What Is the Compounding Quality Act and What Should Compounding Pharmacists Know?
The Compounding Quality Act is one of two parts contained in the Drug Quality and Security Act (DQSA) signed into law by President Barack Obama on Nov. 27, 2013; the second is the Drug Supply Chain Security Act. The Compounding Quality Act itself is built in two parts: one addressing section 503A of the Federal Food, Drug and Cosmetic Act (FDCA) and aimed at “traditional” compounding pharmacists who compound medications to fill specific prescriptions, and the second addressing some of the issues that led to the 2012 Framingham outbreak and building a regulatory framework around large-quantity manufacturing facilities.2
Part one essentially re-establishes the FDCA’s section 503A, which declares that pharmacists must, among other requirements:
- Compound drugs only for particular prescriptions (patient-specific compounding);
- Use drugs and inactive ingredients that are part of a national standard;
- Not use any ingredients that have been withdrawn from the market for safety reasons;
- Not use any ingredients listed on a federal “demonstrably difficult” to compound list.3
It further states that if a compounding pharmacy wishes to distribute more than 5 percent of its prescription medication orders to states outside its physical location, then it may only operate in states that have signed a memorandum of understanding (MOU) with the FDA detailing interstate distribution of compounded drugs.
The second part of the Compounding Quality Act is aimed at addressing the conditions at larger manufacturers that led to the 2012 meningitis outbreak. The Act established a voluntary category for “outsourcing facilities” under the FDCA’s original section 503B. If a compound drug manufacturer making sterile products chooses to register as an outsourcing facility, there are some incentives: the manufacturer does not need to go through the FDCA’s time-consuming, complex approval requirements for new drugs; and the manufacturer may sell drugs on the FDA’s drug shortage list without pre-existing patient prescriptions, at unlimited amounts and anywhere in the country.4
The manufacturer registering as an outsourcing facility must, however, comply with the FDA’s current good manufacturing practices (CGMPs) for compounding, which includes requirements that the manufacturer:
- Use only bulk ingredients that appear on the official FDA list;
- Report all drugs sold in the six months prior to registering to the Secretary’s office, and continue to report all drugs sold in six-month intervals;
- Ensure a pharmacist with a license in the state where the compounding occurs is given oversight over all compounded pharmaceuticals;
- Report serious adverse events to the FDA within 15 days of occurrence, and conduct follow-up investigation and reporting;
- and label compounded drugs with a statement identifying them as such, and including all other pertinent information about the drug.
Compounded drug manufacturers who choose not to register as outsourcing facilities and who also do not meet the definition of a “traditional pharmacy” under 503A continue to be governed by all the requirements of the FDCA like all conventional manufacturers. They must go through the new drug approval process and comply with those CGMPs.5
What’s Next for the Compounding Quality Act?
Keeping in mind that compounded medications and compounding pharmacies are crucial to today’s health care landscape and for providing high-quality and effective patient care, the FDA has moved deliberately with implementing the Compounding Quality Act, soliciting feedback throughout the process.
To build out lists of approved bulk drug substances, the FDA requested nominations in 2014. Most recently, the FDA issued a guidance for operators who may be considering whether or not to register as an “outsourcing facility” under section 503B, given the advantages but also stricter CGMPs that come with that categorization.6
Several items remain to be clarified, however, including the fact that the law does not address in-office compounded medications kept on hand by doctors, nor does it address biologicals or veterinary compounding. The law also states that traditional compounding pharmacies under section 503A may keep a limited quantity” of anticipatory compounds created based on a patient’s prescribing history but before an actual prescription, but is not clear on what that “limited quantity” entails.7
Generally, the compounding pharmacy community and the FDA both understand that a stronger regulatory framework built in a collaborative manner and not designed to stifle compounding can help safe, effective compounded drugs reach patients when they are needed. Creating safer, more effective, tailored medications by combining natural and pharmaceutical compounds is a practice that traces back to the ancient Egyptians. In our own country, specialists have been compounding medications since the 1800s, and today’s compounding pharmacists continue to work toward patient safety and providing the best possible medications for patient care.8
Pharmaceutica North America is the premier provider of high-quality pharmaceutical compounds for compounding pharmacies to create compound medications for improved patient care. Contact us today to learn more about our unit-dose APIs, active compound kits and more.
- “Regulating Compounding Pharmacies,” May 1, 2014, http://www.healthaffairs.org/healthpolicybriefs/brief.php?brief_id=114 ↩
- “Legislation, Regulation and Advocacy,” http://www.nhia.org/resource/legislative/CompoundingActionCenter.cfm ↩
- “IACP Comparison of 503A and 503B: The Drug Quality and Security Act of 2013,” http://c.ymcdn.com/sites/www.iacprx.org/resource/resmgr/imported/IACP%20Comparison%20DQSA%20503A%20and%20503B%2001202014.pdf; “Pharmaceutical Compounding Quality and Accountability Act: Summary of the Bipartisan Senate Legislation,” http://www.help.senate.gov/imo/media/Section-by-Section_PCQA.pdf ↩
- “Regulating Compounding Pharmacies,” ibid. ↩
- “Legislation, Regulation and Advocacy,” ibid. ↩
- “FDA Implementation of the Compounding Quality Act,” July 22, 2015, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm375804.htm ↩
- “Regulating Compounding Pharmacies,” ibid. ↩
- “What is Compounding?” http://www.pccarx.com/what-is-compounding ↩