The year 2013 saw the FDA implementation of the Compounding Quality Act, a U.S. federal law that was created in response to unsafe drug compounding practices. This was particularly in response to the 2012 fungal meningitis outbreak that was linked to contaminated steroid injections from a compounding pharmacy. The outbreak spread across multiple states, and there were 64 reported deaths.
What is the Compounding Quality Act?
The Compounding Quality Act is one of two main parts of the Drug Quality and Security Act (DQSA), which was signed into law in 2013. It was created to regulate drug compounding practices, with a focus on safety and quality control. They aimed to fix regulatory gaps exposed by the 2012 fungal meningitis outbreak.
Key Requirements Under the Compounding Quality Act
The key requirements under the Compounding Quality Act include FDA registration for outsourcing facilities, adherence to Good Manufacturing Practices (cGMP), compliance with sterile preparation standards, and routine inspections to ensure quality and safety.
Major Events That Led to the Act’s Implementation
Traditionally, compounding medication was done on a small scale and patient-specific. Over time, some compounding pharmacies began mass-producing drugs without FDA oversight, blurring the lines between compounding and manufacturing. In 2012, contaminated steroid injections from the New England Compounding Center caused a nationwide Fungal Meningitis outbreak, resulting in more than 750 infections and over 60 deaths.
The legislative and regulatory response to safety issues in drug compounding was swift and significant. After the fungal meningitis outbreak, Congress held hearings to investigate the failures in oversight. Lawmakers identified the need for stronger federal authority over certain compounding practices. In 2013, the House and Senate passed the Drug Quality and Security Act. This gave the FDA clearer authority over large-scale compounders.
Who the Act Affects and Their Roles
The Compounding Quality Act affects 503A and 503B pharmacies in the following ways: 503A facilities must fill patient-specific prescriptions; the main oversight remains with the state board of pharmacy, but the FDA may inspect if there is suspicion of unsafe practices.
For 503B pharmacies, they may compound without individual prescriptions, but only for healthcare facilities. They must register with the FDA, comply with cGMP, and report adverse events and product information to the FDA.
Licensed Pharmacists must follow the same rules applied to their type of pharmacy. In addition, 503A pharmacists must strictly follow state laws and ensure that all compounded products are tied to an actual prescription. Whereas a 503B pharmacist can compound sterile medication in bulk without prescriptions for hospitals or clinics.
Pharmacy Technicians have to follow similar rules to pharmacists in their respective pharmacies. These technicians may also require additional training and certification.
Healthcare Providers, which include nurse practitioners, physician assistants, and doctors, must provide individual, patient-specific prescriptions for 503A pharmacies to legally dispense compounded drugs.
Outsourcing Facilities are 503B registered compounding facilities that produce sterile drugs in bulk. They must follow cGMP regulations, and they sell non-patient-specific compounded drugs.
How Did the Act Impact the Pharmaceutical Industry and the Consumers?
The Compounding Quality Act had a dual impact on both the pharmaceutical industry and consumers. It reshaped regulatory responsibilities, altered business dynamics, and improved drug safety for patients.
After the 2012 NECC meningitis outbreak, the CQA restored public confidence by enforcing higher safety and sterility standards. They reduced the risk of contamination, infection, and serious health outcomes from unsafe compounded drugs. With strict FDA oversight, mandatory inspections, and adherence to strict manufacturing practices, compounders faced pressure to improve safety practices.
The Quality Compounding Act ensures the consistency and reliability of compounded medication by enhancing oversight, standardizing production practices, and clarifying regulatory responsibilities.
Rigorous production protocols are essential to ensuring that compounded medications are consistent, safe, and effective. These protocols form the foundation of quality assurance in pharmaceutical production.
The FDA’s public registry of outsourcing facilities plays a crucial role in helping healthcare providers and consumers make safer choices when looking for compounded medication.
The QCA allows for traditional compounding (503A) by a licensed pharmacist based on a valid patient-specific prescription. This allows a patient to obtain personalized treatment when no suitable drug exists.
FDA’s Role in Enforcing the Compounding Quality Act
The FDA implements the Compounding Quality Act by creating regulatory frameworks, inspecting facilities, issuing guidance, and taking enforcement action when needed. Its goal is to ensure that compounded medications are safe, sterile, and consistently produced.
Compounding pharmacies must follow a combination of federal regulations, the FDA Guidelines, and USP standards to comply with the Quality Compounding Act. The traditional 503A pharmacies compound individualized medications based on prescriptions for a specific patient. A 503B pharmacy may compound medication in bulk without a prescription, but must register with the FDA and meet manufacturing level standards.
In order to comply with the Compounding Quality Act, 503A, pharmacies must follow State regulations and USP standards, and only compound for individual patients. 503B Outsourcing facilities must follow federal registration, cGMP, and FDA reporting requirements, and may produce in bulk without a prescription.
Empower Your Health With Expertly Compounded Medications
At MediVera, we specialize in creating personalized medications when FDA-approved options aren’t suitable. Our pharmacy operates in full compliance with federal and state compounding regulations, including all provisions of the Compounding Quality Act.
Your health deserves the highest standards. See how MediVera ensures safe, reliable medications every step of the way
