More Than 20 Organizations Urge Congress to Address FDA Implementation of DQSA

Broad Provider and Pharmacy Coalition Urges Congress to Fix Drug Quality and Security Act

 
A broad cross-section of organizations representing varied health care providers and the pharmacy community has sent a letter to U.S. Senate and House leaders expressing 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.
 
“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.”
 
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 the International Academy of Compounding Pharmacists. “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.”
 
Office-use enables many physicians to order compounded prescription preparations in their practices to care for patients when manufactured drug products are either unavailable or do not provide the necessary strengths, dosage forms, or combinations of medicines they need. Repackaging of manufactured drug products for office-use is also done by pharmacists so that medications can be made available in the necessary dosages and strengths for physicians to administer in the office.
 
Office-use is often used to meet an urgent patient need and these medications are administered to treat viral infections, vitamin deficiencies, and macular degeneration (which if left untreated can cause immediate blindness). They are also used as anesthetic agents for outpatient surgical procedures, and for many other purposes by doctors.
 
When drafting and enacting the DQSA, Congress made six statements in the Congressional Record expressing that office-use compounding should remain governed by state laws.
 
“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,” said IACP’s Miller. “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.”