On October 25, 2021, the Food and Drug Administration (FDA) expressed “concerns” over compounding under insanitary conditions occurring in settings other than pharmacies. Compounding varies widely by medical specialty and ranges from medical spa dermatology treatments to hormone replacement therapy, intravenous hydration or vitamin therapy. In 2016, FDA included in-office compounding in its definition of compounding facilities and included “licensed physician” alongside “licensed pharmacist” throughout its final guidance “Prescription Requirements Under Section 503A of the Federal Food Drug and Cosmetic (FDC) Act”.[1] Under § 503(a) of the FDC Act, physicians that do patient-specific in-office compounding in medical offices, clinics and spas are not required to register with either the FDA or state boards of pharmacy. However, those involved with these business models may not be aware that they need to adhere to § 503(a), United States Pharmacopoeia (USP) standards and comply with state compounding regulations. The § 503(a) requirements are extensive and include labeling requirements, prohibitions on compounding large quantities in anticipation of patient volume, compounding for retail sale, or compounding commercially available products, and limits on interstate distribution. With regard to USP standards, USP 795, 797 and 800 apply and pertain to, for example, sterile compounding infrastructure, handling of hazardous drugs, and the responsibilities of supervisors of compounding, i.e. physicians.
Compared with pharmacy compounding, physician compounding has, for the most part, been loosely regulated. State Medical Board oversight remains complaint driven. This is mostly the result of a lack of clarity for physician in-office compounding since FDA, state agencies and state Boards of Pharmacy often have different rules and are not on the same page. While most state compounding laws often do not specifically address non-pharmacist compounders, approximately ten do and some also engage in routine inspections. For example, the Ohio Board of Pharmacy requires physician compounders to registers as “Terminal Distributors of Dangerous Drugs.”[2] In North Carolina, the state Board of Medicine has established compounding standards for physicians that mirror FDA and USP requirements. FDA itself, however, has previously stated it will apply a risk-based approach and drugs that create “negligible patient risk” would be subject to less stringent compliance such as aseptic technique. Physicians must ensure they have equipment, materials, space and training protocols necessary to comply with applicable standards.
While FDA did not issue any new rules or guidance’s for physician compounding on October 25, the FDA warned of increasing instances of non-compliant and dangerous compounding practices, thus signaling its intention to close the regulatory gap. Issues involving cross contamination and inappropriate multi-use of bulk volume containers, antimicrobial contamination and other safety issues leading to patient harm are driving advocacy that the regulatory gap be finally closed. In view of the FDA’s October 25 warning, those compounding in medical offices, clinics and spas should consider the level of risk associated with products they compound and whether FDA and USP standards would be viewed as the standard of care for the purposes of negligence.
How Frier Levitt can help
We counsel regularly regarding § 503(a) and state-specific compounding requirements as it relates to licensed pharmacies and physicians that dispense drugs under their plenary licenses. We can assess your compounding practices for state and federal regulatory compliance, including medical necessity documentation, reimbursement issues, infrastructure and prepare compounding P&Ps that provide clear guidelines, standards and training for staff.
[1] 21 U.S.C. § 353a.
[2] OH Rev. Code Ann. § 4729.541.
