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Polsinelli - Environmental and Natural Resources
         
 

November 2013

 

Office Use PERMITTED Under New Compounding Quality Act: States Retain Power over Doctors' Ability to Prescribe in Advance

 
 
             
 

Life Sciences Professionals:

 

Kevin R. Sweeney

Practice Area Chair

 

Ari M. Bai
Mary Beth Blake
Yu Cai
Elton F. Dean III
Kathryn J. Doty
Robert O. Enyard Jr.
Anita R. Estell
Geoffrey D. Fasel
Ron Galant
Melissa Gilmore
Kimberly A. Honeycutt
Andrew T. Hoyne
J. Morgan Kirley
Gregory M. Kratofil
Jane K. McCahill
Cortney E. Mendenhall
Tara A. Nealey
Jay E. Pietig
Andrea M. Porterfield
Rebecca C. Riley-Vargas
Thomas J. Schenkelberg
Kelley A. Schnieders
Teddy C. Scott
Christopher P. Simpson
Timothy D. Steffens
James M. Stipek
Steven K. Stranne
Kevin R. Sweeney
Tracey S. Truitt
Brian G. Wallace
Michael A. Williamson
Patrick C. Woolley

 

To learn more about our Life Sciences practice, or to contact one of our Life Sciences attorneys, click here.

 

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A key interpretation of the Compounding Quality Act (CQA) passed by Congress this week indicates that the ability of doctors to compound for office use in advance of an individual patient prescription is safe from federal interference. This practice, commonly referred to as office use, is a critical tool in the ability of doctors to care for their patients. The CQA itself is silent on the practice, leaving states, doctors, and patients concerned about its continued existence.

But several key lawmakers spotted the problem and rose to clarify:

  • Because office-use compounding is not addressed by the compounding section of FDA law, the agency should not overstep states' authority in this area, said Sen. John Boozman (R-AR).

    • "The omission of office-use from section 503(a) of the Food, Drug and Cosmetic Act should not signal to the FDA that it has the authority to encroach upon state authority to regulate office-use," Boozman said, according to the congressional record.
    • "This is not the intent of the law, and I will closely monitor FDA implementation as this process moves forward. If the State of Minnesota wants to prohibit drug repackaging and compounding--that is its decision. But again, this law is by no means a green light for the FDA to usurp the rights of States. I want to make that crystal clear."

Moreover, the CQA is not a usurpation of power over the practice of medicine.

  • Sen. Tom Coburn (R-OK) also said the bill should not "be used by the FDA to interfere with a doctor's ability to practice medicine and choose the best therapy for his or her patients."

    • He said he received assurances from Sen. Lamar Alexander (R-TN), ranking member of the Senate health committee, that the intent of the legislation is not to limit access to necessary treatments.
    • "I agree with him, and want to clarify that nothing in this legislation will constrain a doctor's options to practice medicine," Alexander said. "The legislation tries to ensure that if a doctor or patient needs access to compounded drugs, that there is an FDA-regulated source for those drugs where the quality standards are uniform nationwide. Doctors know their patients best and should have access to accurate information on the safety and quality of the drugs they use. If there are unintended consequences to this legislation, I stand ready to work with my colleagues and provide necessary oversight."

The full article is available here.

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