July 1, 2013. At the request of Rep. Morgan Griffith (R-VA), who has taken the lead on drafting compounding legislation for the House Energy & Commerce Subcommittee on Health, APhA commented June 7 on a regulatory concept that relied on a draft Compliance Policy Guide that had been under development by FDA before the recent fungal meningitis outbreak.
“While APhA is supportive of making sure that nothing like this occurs again, we are also concerned that overreaching changes to the law could inadvertently block patient access to needed compounded medications,” the Association wrote in the comment letter. “Our utmost concerns are patient safety and access to best treatment options and access to quality medications, including appropriate compounded medications.”
APhA staff meet with Griffith’s office
Following the requested comment letter, APhA staff met with Griffith’s office on June 10 and will continue to work with him as the legislative process moves forward. “It was a very productive meeting,” said APhA Senior Lobbyist Michael Spira. “I would expect we might see legislation in the coming weeks.”
House Republicans are pushing to introduce compounding legislation in the near future because on the Democrat-controlled Senate side, the Health, Education, Labor, & Pensions Committee chair and ranking member have asked Senate Majority Leader Harry Reid (D-NV) to put its compounding bill on the floor by the July 4 recess, according to Spira. The House “has to put its marker down or they will be forced to deal with the Senate bill,” he explained. Even though the Senate bill is bipartisan, the House has indicated it won’t take up the Senate bill.
The House Energy & Commerce Subcommittee on Health held a hearing on examining drug compounding on May 23. Two previous hearings on compounding were held by the Subcommittee on Oversight and Investigations.
‘Compounding is part of the pharmacy profession’
The Association’s June 7 letter to Griffith’s office highlighted several compounding issues and referred to 2008 APhA policy on pharmacy compounding accreditation (see sidebar).
“Compounding is an integral part of the pharmacy profession and was virtually synonymous with the practice of pharmacy for many years prior to the inception of large-scale and widespread pharmaceutical manufacturing,” APhA wrote. “Common examples where compounding serves a critical patient need include preparing dosage forms to enhance medication administration and adherence, preparing a formulation that excludes an ingredient known to trigger a patient’s specific allergic response, maintaining a patient on a medication when there is a drug product shortage, and providing a drug product in a specific and customized strength or dosage form. In addition, cancer patients with challenged oral intake may require oral medications compounded into other dosage forms that meet that particular patient’s needs.”
Continued APhA’s letter: “There continues to be an appropriate place for customized compounding of medications in today’s health care system.”
APhA policy on pharmacy compounding accreditation (2008)
- APhA reaffirms the 1992 Compounding Activities of Pharmacists policy, which states that APhA affirms that compounding pursuant to or in anticipation of a prescription or diagnostic preparation order is an essential part of health care that is the prerogative of the pharmacist.
- APhA supports compounding as defined by the Pharmacy Compounding Accreditation Board (PCAB) as a means to meet patient drug therapy needs.
- APhA opposes compounding when identical medications are commercially and readily available in strength and dosage form to meet patient drug therapy needs.
- APhA asserts that compounding is subject to regulations and oversight from state boards of pharmacy. APhA urges state boards of pharmacy to identify and take appropriate action against entities who are illegally manufacturing medications under the guise of compounding.
- APhA supports accreditation of compounding sites by PCAB to ensure patient safety. APhA encourages state boards of pharmacy to recommend accreditation for those sites that engage in more than basic nonsterile compounding as defined by PCAB.
- APhA supports the development of education, training, and recognition programs that enhance pharmacist and student pharmacist knowledge and skills to engage in compounding beyond basic, nonsterile preparations as defined by PCAB.
- APhA encourages the exploration of a specialty certification in the area of compounding through the Board of Pharmaceutical Specialties (BPS).
(JAPhA NS48(4):470 July/August 2008) (Reviewed 2009)(Reviewed 2011)
