Broad Provider and Pharmacy Coalition Urges Congress to Fix Drug Quality and Security Act
Wednesday, December 10, 2014
Posted by: Dagmar Anderson
Last night, a broad cross-section of organizations representing varied health care providers and the pharmacy community, brought together by the International Academy of Compounding Pharmacists (IACP), sent a letter to U.S. Senate and House leaders. The letter expresses serious concerns with the federal government’s implementation of the Drug Quality and Security Act (DQSA), enacted in November 2013, and is calling on Congress to fix the law.
This morning, IACP has distributed a press release to the nation's media announcing the congressional letter, and the specific DQSA-related issues on which these health care providers are concerned.
The Food and Drug Administration’s current interpretation of the DQSA essentially eliminates all repackaging of medications and creates barriers to office-use by requiring a prescription in advance of a compounded medication’s preparation. This runs counter to the intent of office-use, which is the method by which physicians and other prescribers obtain medications from pharmacists to administer and treat patients.
“The letter to Congress is designed to send a very clear message to lawmakers from the broadest possible array of physicians, health care practitioners, and pharmacists: the law as you wrote and intended it is not being carried out,” said David G. Miller, R.Ph., Executive Vice President & CEO of IACP. “This is troubling to practitioners and pharmacists alike, but it is most worrisome for patients, who often have an immediate need for a medication that they cannot get because of the way this law has been incorrectly interpreted and applied. People are suffering as a result.”
Miller continues, "While the pharmaceutical industry has praised the FDA for its implementation of DQSA, the people who take care of patients each and every day – physicians, nurses, and pharmacists – are seeing accessibility to vital compounded medications hindered. Much of that impact is due to the FDA's attempt to define more broadly the instructions it was given by Congress, putting health care providers in the 'no man's land' of complying with their state law or the federal law, which are not in agreement.”
Please click here for a copy of IACP's press release.