HR 3089 – The Compounding Clarity Act
In comparison to similar legislation on the Senate side, HR 3089 focuses primarily on clarifying sections 503(a) of the Food Drug and Cosmetic Act rather than providing sweeping new authorities for the Food and Drug Administration to gain greater authority over traditional pharmacy compounding. Within the past few days, the National Community Pharmacists Association (NCPA)
and the third-party PBM Express Scripts
both issued formal letters of support for 3089.
“Even though we believe the House has a better understanding of the problems that lead up to the NECC tragedy last fall – particularly the failure of both state and federal agencies to take prompt action against a pharmacy that had violated the law – there are still several areas of concern for compounding pharmacists,” said IACP President Wade Siefert. “The IACP leadership met several times over the past few days and while we are generally supportive of the bill, we must resolve some specific areas that undoubtedly impact our ability to care for our patients.”
A few of the key points that IACP is watching carefully:
- “Anticipatory compounding”, an important issue for IACP, is included in the bill using essentially the same language that existed previously in 503(a). This includes that any anticipatory compounding must be done based upon a history of prescriptions generated within an established relationship between a physician/prescriber and a compounding pharmacists.
- Compounding must be conducted in compliance with USP <795> and USP <797> chapters. Those standards will apply to all professionals engaged in compounding regardless of location or practice type.
- The ability to compound using Active Pharmaceutical Ingredients (APIs) which previously appeared in 503(a) is retained. That requires that an API must have a USP/NF monograph, be a component of an FDA approved product, or appear on a list of approved APIs developed by the Secretary of Health and Human Services. Additionally, the requirement that all APIs must be obtained by an FDA registered supplier remains unchanged.
- New language would enable the FDA to add drugs to the existing “do not compound” list based upon their being “demonstrably difficult” to compound. IACP strongly objects to this new language because the bill does not include a definition of what constitutes “demonstrably difficult” nor does it adequately link that with a demonstrated lack of patient safety and efficacy.
- While pharmacies will be permitted to compound and provide preparations for “office use”, pharmacies may not act as wholesalers of compounded drugs. That is a new prohibition. For “office use”, a pharmacy would be responsible for obtaining the names of all patients to whom a medication was administered by the prescriber within seven days of administration. Additionally, no more than 5% of total prescriptions dispensed semi-annually may be sterile drug preparations distributed over state lines (interstate) as an office-use medication. IACP believes that this section in particular creates problems because the federal requirement may be in direct conflict with existing and evolving state laws on office-use sales and distribution.
- State Boards of Pharmacy and the FDA will be required to communicate with one another whenever an action is taken against a compounding pharmacy including warning letters, sanctions, or penalties. The FDA will be required to communicate with the state Board if it receives a complaint about a compounded medication or pharmacy. This section, lacking in the Senate version, is the direct result of the House Energy and Commerce Committee’s investigation into the NECC tragedy and the revelation that the FDA was very much aware of the problems at that pharmacy but failed repeatedly to interact adequately with the Massachusetts Board of Pharmacy.
- A new category of FDA licensure called an “outsourcing facility” would be created that applies to pharmacies or other businesses which compound and distribute more than 5% of their sterile medications for office-use over state lines. These new facilities would be subject to cGMP requirements. While this is similar to the “compounding manufacturer” concept in the Senate bill, what is still unclear is whether a pharmacy may remain a pharmacy and be an outsourcing facility as well. In the Senate version, a compounding manufacturer could NOT be a pharmacy and would have to be established as a separate business.