Trouble with images? View as a Web page.

Polsinelli - Environmental and Natural Resources
         
 

November 2013

 

Key Points: Compounding Quality Act

 
 
             
 

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.

 

View Polsinelli documents on JD Supra  
LinkedIn Twitter Facebook Inside Law Podcast Connect with us on LinkedIn. Connection with us on Twitter. Connect with us on Facebook.

 

   

The Compounding Quality Act (CQA) amends the U.S. Food, Drug & Cosmetic Act (Act) to create a new, voluntary category of compounders called "outsourcing facilities" (OF). Compounded drugs are those mixed by a pharmacist that differ from commercially available drugs according to individual needs. If a pharmacy chooses to register as an OF, it will be exempt from the new drug application, labeling, and track and trace requirements imposed on pharmaceutical manufacturers. In addition, the OF will be permitted to dispense drugs without an individual patient prescription.

In order to register as an OF, the facility must do the following:

  • Compound by or under the direct supervision of a licensed pharmacist;
  • Pay a $15,000 annual fee (small business fee TBD);
  • Register annually with FDA;
  • Report to FDA every June and December:
    • what drugs have been compounded in the facility in the prior 6 months
    • adverse events;
  • Allow FDA inspections
    • on a risk-based frequency schedule, depending on prior safety performance
    • additional fees to be assessed if reinspection is necessary.

OFs are prohibited from:

  • Compounding from any bulk substance that does not appear on a list of APIs deemed permissible by FDA;
  • Compounding any drugs that appear on a list of drugs deemed by FDA to be demonstrably difficult to compound;
  • Reselling a compounded drug;
  • Intentionally falsifying a prescription for a compounded drug.

Under the CQA, state boards of pharmacy are required to notify FDA of:

  • any disciplinary actions taken against compounding pharmacies or any recall of a compounded drug, and
  • intentionally falsifying a prescription for a compounded drug.

The CQA also:

  • Removes former prohibitions on advertising, promotion, and solicitation of prescriptions by compounding pharmacies;
  • Requires the GAO to issue report on pharmacy compounding and the adequacy of state and federal efforts to assure the safety of compounded drugs.

If a business chooses to register as an OF, it will continue to be subject to state pharmacy regulations as supported by Section 503A of the Act. The next article in this series will address businesses that choose to remain non-OF compounding pharmacies.

For More Information

For more information about the contents of this eAlert, please contact:

 
             
             

             
 

Chattanooga  Chicago  Dallas  Denver  Edwardsville  Jefferson City  Kansas City  Los Angeles  New York  Overland Park
Phoenix  St. Joseph  St. Louis  Springfield  Topeka  Washington, D.C.  Wilmington  
www.polsinelli.com

 
             
 
 

ABOUT POLSINELLI

real challenges. real answers.SM  
Serving corporations, institutions, entrepreneurs, and individuals, our attorneys build enduring relationships by providing legal counsel informed by business insight to help clients achieve their objectives. This commitment to understanding our clients' businesses has helped us become the fastest growing law firm in the U.S. for the past five years, according to the leading legal business and law firm publication,
The American Lawyer. Our more than 680 attorneys in 17 cities work with clients nationally to address the challenges of their roles in health care, financial services, real estate, life sciences and technology, energy and business litigation. The firm can be found online at www.polsinelli.com. Polsinelli PC. In California, Polsinelli LLP.

 
 
             
 

To update your email preferences, please contact Kim Auther at KAuther@polsinelli.com. To opt out of these communications, click the unsubscribe link below.

Polsinelli provides this material for informational purposes only. The material provided herein is general and is not intended to be legal advice. The choice of a lawyer is an important decision and should not be based solely upon advertisements.

Copyright © 2013 Polsinelli PC.

 
             
Connect with us on LinkedIn. Connection with us on Twitter. Connect with us on Facebook.