IACP Takes Lead on Senate Compounding Legislation
After months of intensive work with Congress, the International Academy of Compounding Pharmacists (IACP) is directly involved in proposing revisions and recommendations to the Senate HELP draft legislation on pharmacy compounding oversight. That draft, released on April 26, 2013, has many potentially harmful provisions which your Academy is fighting to remove. These include:
- Restrictions on veterinary compounding.
- Elimination of office-use compounding.
- Elimination of anticipatory compounding.
- An exemption for hospitals and health-systems from any oversight.
Today, May 3, 2013, IACP is submitting recommended revisions of the legislation with explanatory notes to the Senate Committee. Those documents, once received by Congress, will be shared with all IACP members.
Next week, on Thursday, May 9, IACP will be the only organization representing the professional and business interest of pharmacy compounders in a formal hearing before the Senate.
Our comments on the draft legislation and our recommendations for language change reflect our commitment to assuring that all patients have confidence in the quality and safety of their medications -- including those compounded specifically to meet their health needs by pharmacists and physicians. We believe that any final legislation enacted by Congress must, first and foremost, hold all parts of the healthcare system accountable and responsible for protecting patient safety and access to compounded medicines. These recommendations include suggested to language to the draft that:
- Clarifies that whenever a non-traditional manufacturer compounds a drug and enters it into interstate commerce, it is considered a "new drug" and subject to FDA oversight as such.
- Further strengthens the differentiation between a pharmacy or practitioner engaged in compounding for patient care and entities which are engaged in manufacturing for sale and distribution.
- Assures patients that the compounded medications they receive are regulated in the same way regardless of whether they are obtaining that medicine from a local pharmacy or while they are hospitalized by eliminating a "loophole" that would not hold hospital and health-systems accountable to the same standards.
- Eliminates confusion and further uncertainty between federal and state law by including language that recognizes the compounding for and dispensing to prescribers for treatment of their patients in their offices.
- Requires the FDA to be accountable and take seriously the existing regulations that identify drugs that are unsafe and should be placed on a "do not compound" list. While the agency has Congressional authority to do so already, it has left the "do not compound" list languish for more than a decade.
- Preserves patients’ access to medications that are customized formulations, strengths, or composition of manufactured drug products. Many patients have unique health conditions which require compounded versions of manufactured drug products which are not available.
- Creates consistency between the compounding of drugs for humans with drugs for animals rather than creating disparate standards, rules and requirements.
- Reaffirms the responsibility of states to oversee traditional physician, pharmacist and veterinarian compounders.
- Mandates that the FDA report to Congress on how they have handled any complaint about a compounded medication in a manner that is transparent and accountable.
What can you do?
Plan and participate in next week’s IACP Town Hall Teleconference.
Plan to attend IACP’s Compounders on Capitol Hill at the end of the month and help us protect you and your patients.
Be prepared to call and write your Senator and Congressman when the final bill is introduced.
Be prepared to activate your customers and patients to reach out to their Senator and Congressman when the final bills is introduced.
Stay committed and stay confident. Pharmacy compounding is a vital service to the health care system and IACP is there to make sure it stays that way.