The International Academy of Compounding Pharmacists (IACP) has reported a sharp increase in FDA inspections of compounding pharmacy facilities. Last week, over a dozen pharmacy practices that engage in sterile compounding declared that FDA representatives inspected their facilities, including both sterile and non-sterile compounding activities. These investigations followed speculation that the FDA plans to inspect all sterile compounding facilities within the next 12 to 18 months in the wake of the Compounding Quality Act (CQA) and its provisions relating to the oversight of compounding of human drugs.
Under section 503A of the federal Food Drug and Cosmetic Act (FD&C Act), as amended by the CQA, pharmacists may compound a drug for an individual patient pursuant to a prescription written by a licensed healthcare provider. Section 503A exempts compounded human drug products from certain FD&C Act requirements, including the statutory requirements of new drug approval, current good manufacturing practice (cGMP) requirements, and labeling for adequate directions for use based on a set of standards and requirements. Failure to comply with all of the elements of applicable elements of 503A will subject the compounded drug to the full scope of the FD&C Act.
The FDA considers pharmacies that compound drug products beyond those for identified individual patients pursuant to a valid prescription to be in violation of 503A. This includes compounding of any medication for office-use. Therefore, the FDA considers a compounding pharmacy engaging in office-use ineligible for the exemption provisions within 503A, and are thus subject to increased scrutiny and heightened standards under the FD&C Act.
The FDA has declared its plans to take aggressive action against compounding pharmacies in violation of federal law, regardless of compliance with state pharmacy law, including enforcement actions, such as warning letters, seizures of product, injunctions, or criminal prosecution. The FDA expects to employ a risk-based investigation and enforcement approach, with an eye toward sterile compounding facilities.
In 2015 alone, the FDA has taken enforcement action on ninety-one compounding pharmacies as of September 9, 2015. These actions include fifty-nine Form 483s resulting from inspections, twenty-one warning letters, eight referrals to state boards of pharmacy, and multiple press releases and statements.
Fail to prepare and prepare to fail. Compounding pharmacies should consider the following select best practices for FDA inspections:
- Have a written plan maintained in a binder and located for easy access by responsible personnel. This plan should include the name, phone number, location at site of a person assigned responsibility to initially meet and accompany the FDA Inspector, as well as a list of senior management officials, name, phone number, and location on site. This plan should also include the location, office or conference room for FDA Inspector use during the inspection.
- Ensure proper documentation and storage of records.
- Invest time and designate accountable resources to implement and assess an effective compliance program.
- Provide continuous training for personnel in relation to compliance requirements.
- Engage in appropriate environmental controls and quality testing as required by the USP.
- Foster a culture of compliance within your organization.
With FDA leadership declaring dedication to the enforcement of the CQA, pharmacies should anticipate a continued increase in inspections and be wary of potential deviations from the requirements of 503A that would remove the pharmacy from the statute’s exemptions. In light of these trends, pharmacies should ensure that that their practices are fully compliant with all of the applicable regulations under the FD&C Act. For assistance in ensuring your pharmacy practices are compliant with section 503A and 503B of the FD&C Act, contact Frier Levitt.
