U.S. Senate HELP Committee Releases a Revised Compounding Bill Draft
The U.S. Senate Committee on Health, Education, Labor & Pensions (HELP) has released a revised version of its Pharmacy Compounding draft bill. The International Academy of Compounding Pharmacists' (IACP) legislative team has received a copy of the draft bill and isthoroughly reviewing it.
While IACP has committed to continued work with the Senate HELP Committee and its staff, we have serious reservations that this proposed language will actually hinder patient care rather than protect patient safety -- the stated intent of the entire legislative discussion. Your Academy has multiple strategies already developed to address a variety of legislative scenarios -- all with an eye towards preserving pharmacy compounding practice while balancing that with the need to assure that entities that exceed the scope of practice are appropriately identified and regulated.
IACP's Initial Observations Regarding the Revised Draft Based on Preliminary Review:
In a preliminary review of the revised draft, we believe that the proposed compounding bill still needs to contain provisions that speak directly to standards aimed at raising the quality of compounded medications. The IACP supports uniform and nationwide standards, which compounding pharmacies would be held to, to be overseen by the state boards of pharmacy. We have and will continue to work with state pharmacy boards and professional organizations to introduce and support legislation and regulations which require compliance with those standards.
First and foremost, IACP strongly believes that patients must be assured that the compounded medications they receive are regulated effectively and consistently, regardless of whether they are obtained from a local pharmacy or during hospitalization. That is, an exemption should be eliminated from the draft bill that would not hold hospital and health-systems accountable to the same standards.
Additional IACP observations regarding the revised compounding bill draft:
- The draft legislation creates a new category in the industry, that of “compounding manufacturer,” which the legislation envisions being regulated by the FDA. While we continue to state that the FDA already has sufficient authority to create additional categories of manufacturers as necessary to assure drug product safety, IACP believes the term "compounding manufacturer" and several of the definitions of that new category create more confusion and further blur the jurisdictional authority of regulators.
- Language in the bill should be adjusted to eliminate confusion and further uncertainty between federal and state law – in particular by including language that recognizes compounding for, and dispensing to, prescribers for treatment of patients in their offices.
- The bill should be consistent in its treatment of compounding of drugs for humans and drugs for animals, rather than creating inexplicably disparate standards, rules, and requirements.
Please click here to view the revised Senate draft bill.
Senate HELP Committee to Hold Hearing May 22nd
The Senate HELP Committee will hold an additional hearing on May 22, 2013, at 10 a.m., 430 Dirksen Senate Office Building regarding the Pharmaceutical Compounding Quality and Accountability Act. The IACP staff and legislative team will be in attendance at this hearing.