Compounding Pharmacy (503A/503B) Compliance Checklist for Distributors & Operators
Both 503A and 503B compounding pharmacies must follow a myriad of legal requirements as a condition of operation. The failure to follow these compliance obligations could lead to FDA or state enforcement action, or even the loss of the ability to do business. These obligations could shift, depending on changes in the legal framework and regulatory interpretations by the relevant authorities. Therefore, it is essential that you stay on top of both knowing your compliance responsibilities and following them.
Speak to an experienced national compounding pharmacy lawyer at Innova Health Law to learn more about how we can help you by calling us at 281-936-9904. This is a call that you should make as soon as possible because you never quite know when you may be subject to an enforcement action, and you need to be proactive when it comes to compliance.
Compounding pharmacies have numerous compliance requirements that they need to meet to maintain ongoing operations. The exact compliance obligations depend on the pharmacy’s status. 503A and 503B compounding pharmacies have somewhat different compliance requirements. A compounding pharmacy lawyer can explain compliance requirements and help your business take steps to meet them.
503A Compounding Pharmacy Compliance Requirements
A 503A compounding pharmacy fills individual prescriptions written by a prescriber for a single individually identifiable patient. Unlike commercial pharmacies, 503A compounding pharmacies compound unique formulas for these patients due to some type of clinical need like an allergy. While there are regulations that relate to the actual compounding of medications, there are also rules that must be followed with regard to actual patients.
Here are some of the compliance requirements for a 503A compounding pharmacy:
- Each state in which the compounding pharmacy operates has its own pharmacy-related rules that apply within its particular jurisdiction. These rules are written and adopted by each state’s Board of Pharmacy.
- United States Pharmacopeia (“USP”) prescribes its own standards that relate to the purity and efficacy of medications. There are different standards for sterile and non-sterile compounding. In addition to general standards, there may also be rules that relate to specific medications.
- A 503A pharmacy can only compound medications in response to a specific patient prescription.
- Since individual patients are involved, a 503A pharmacy must also follow HIPAA and other privacy requirements
- A 503A compounding pharmacy must be careful not to run afoul of bulk office use rules that would require it to register as a 503B outsourcing facility. There are both FDA and state-specific rules on point.
503B Outsourcing Facility Compliance Requirements
A 503B compounding pharmacy performs the valuable task of manufacturing certain types of drugs when there are shortages. As opposed to filling individual patient prescriptions with compounded medications, their task is to provide larger amounts of drugs to individual pharmacies. As such, the compliance requirements may be somewhat different than those faced by 503A compounding pharmacies.
Some compliance obligations that a 503B outsourcing facility must follow include:
- An outsourcing facility must register annually with the FDA and pay a registration fee.
- A 503B facility must follow the FDA’s Current Good Manufacturing Practices and be prepared to prove that they are in compliance. These practices may be amended by the FDA over time.
- The FDA may conduct inspections of outsourcing facilities to ensure that rules are being followed.
- A 503B Pharmacy must submit semi-annual reports to the FDA concerning products it manufactures
Compliance Obligations for Distributors of Compounded Medications
Distributors of compounded medications have their own compliance requirements that they must follow, since they are part of the supply chain. Distributors also handle the medications, so they must have a similar commitment to sterility and safety. These potential compliance issues include:
- Making sure that they work only with licensed compounding pharmacies
- Retaining documentation that shows that the medications were produced in accordance with Good Manufacturing Practices
- Follow all obligations imposed by the Drug Supply Chain Security Act
- Ensure that they are licensed in each state in which they do business and take steps to maintain their license annually
- Participate in the adverse event reporting process, both in assisting the FDA and in forwarding information about complaints to the compounding pharmacies
As you can see, there are many compliance requirements that must be followed, both in response to specific events and on a regular basis. The good news is that you do not have to worry about knowing what your exact obligations are because a compound and Pharmacy attorney can help you.
Contact a Compounding Pharmacy Law Firm Today
A compounding pharmacy attorney at Innova Health Law has a deep understanding of the regulatory requirements that you must follow, and they can do their part in keeping you informed and assisting you with proactive strategies. You can schedule a free discovery meeting with a compounding pharmacy attorney by visiting our website or by calling us today at (281) 936-9904.