ear Chairman Harkin and Ranking Member Alexander,
Thank you for your continued bipartisan work on the safety of pharmaceutical compounding. We would like to provide additional comments to supplement our letter to the Committee of 22nd May.
Pew, the American Society of Health-System Pharmacists and the American Hospital Association recently hosted a “Pharmacy Sterile Compounding Summit” that brought together diverse stakeholders to assess the risks associated with sterile compounding. Based on the results of this conference our three organizations recommended clarifying oversight of sterile compounding, specifically by strengthening Federal oversight of activities that represent a higher degree of patient safety risk, and that are not currently overseen by States as traditional pharmacy compounding.i
The emergence of a high-volume compounding sector producing high-risk products necessitates an updated quality and oversight framework, including a reexamination of state and federal roles.
S.959 takes a step towards clarifying state and federal oversight of compounding, including an important increase in FDA supervision of certain activities: specifically, the compounding of sterile medicines that are shipped interstate. While we support this increase in oversight, we also urge the Committee to make key changes to further strengthen this bill.
Detailed Comments:
- Compounding manufacturers (CMs) should be prohibited from making non-sterile medicines, or the FDA should be explicitly directed to oversee non-sterile compounding by CMs. (P.4 line 4) The current bill directs the FDA to regulate compounding manufacturers (defined as facilities that make sterile products in anticipation of a prescription and ship them interstate) but does not address compounding of non-sterile products by compounding manufacturers. Since CMs are expressly prevented from being state-licensed pharmacies, this leaves a lack of clarity on quality standards and regulatory oversight. To achieve clarity, the legislation should either expressly require FDA to oversee non-sterile compounding at CMs or prohibit CMs from making non-sterile medicines.
- Ensure that state-licensed pharmacies operating as traditional compounders (TCs) do not become de facto unregulated manufacturers by defining anticipatory compounding. (P.8 line 24) The threshold for allowable anticipatory compounding by TCs is a longstanding area of confusion. The terminology used in section 503(A), as well as this bill, permits anticipatory compounding in “limited quantities” based on prescribing history. FDA’s compliance guide allows “very limited quantities”. These terms are undefined, and are interpreted in widely different ways by different stakeholders. The definition of a traditional compounder in this legislation includes compounding limited amounts in anticipation of a prescription pursuant to state law, which by some assessments also permits compounding without a prescription (aka office stock or hospital supply) where allowed by states.