Have you noticed that many compounding pharmacies have changed their business model? Perhaps they even stopped producing a product for you. Many physician practices and medical spas have suddenly discovered that they can no longer obtain compounded products for their facilities. Many are scrambling to find a new supplier. Many compounding pharmacies have closed and others have had to discover new ways to manufacture a product.
There are a lot of problems associated with the changes in compounding laws. To make matters worse, the changes were sudden. Many believe that the law was enacted as a result of a meningitis epidemic in November of 2013.
President Obama signed the Drug Quality and Security Act at the end of 2013. The Compounding Quality Act which first removes certain provisions from section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) that were found to be an unconstitutional restraint of commercial free speech by the U.S. Supreme Court in Thompson v. Western States Med. Ctr., 535 U.S. 357 (2002).
Subsequent lower court decisions were split over whether 503A was unconstitutional in its entirety or only in part. The Compounding Quality Act clarifies this issue by eliminating the controversial advertising prohibition.
Section 503A otherwise remains unchanged, and continues to set out the requirements for
traditional compounding created in the FDCA – the pharmacist must compound the drug for
individual patients based on a prescription (or a prescription history of an individual or order
history of a physician). One of the FDA guidance documents addresses traditional compounding
and is clear that traditional compounding will generally remain under state pharmacy board
oversight as long as the compounding facility meets the requirements of 503A. A pharmacy that
compounds in compliance with the 503A requirements is exempt from federal good
manufacturing practice (cGMP) requirements, adequate directions for use, and new drug
approval requirements.
Secondly, the Compounding Quality Act adds a new section 503B to the FDC
Act, 21 U.S.C. § 353b, to create a new regulatory classification of compounding facilities called
“outsourcing facilities,” which are to be overseen by FDA instead of state pharmacy boards.
Unlike traditional compounding pharmacies, outsourcing facilities can compound medications
without a patient-specific prescription and sell such products to hospitals and other health care
providers. While an outsourcing facility is exempt from FDA approval requirements and
adequate directions for use, it is subject to cGMP requirements and will be inspected by the FDA
according to a risk-based schedule.
Paddy Deighan J.D. Ph.D
http://www.medicalandspaconsulting.com
There are a lot of problems associated with the changes in compounding laws. To make matters worse, the changes were sudden. Many believe that the law was enacted as a result of a meningitis epidemic in November of 2013.
The Compounding Quality Act
Subsequent lower court decisions were split over whether 503A was unconstitutional in its entirety or only in part. The Compounding Quality Act clarifies this issue by eliminating the controversial advertising prohibition.
Section 503A otherwise remains unchanged, and continues to set out the requirements for
traditional compounding created in the FDCA – the pharmacist must compound the drug for
individual patients based on a prescription (or a prescription history of an individual or order
history of a physician). One of the FDA guidance documents addresses traditional compounding
and is clear that traditional compounding will generally remain under state pharmacy board
oversight as long as the compounding facility meets the requirements of 503A. A pharmacy that
compounds in compliance with the 503A requirements is exempt from federal good
manufacturing practice (cGMP) requirements, adequate directions for use, and new drug
approval requirements.
Secondly, the Compounding Quality Act adds a new section 503B to the FDC
Act, 21 U.S.C. § 353b, to create a new regulatory classification of compounding facilities called
“outsourcing facilities,” which are to be overseen by FDA instead of state pharmacy boards.
Unlike traditional compounding pharmacies, outsourcing facilities can compound medications
without a patient-specific prescription and sell such products to hospitals and other health care
providers. While an outsourcing facility is exempt from FDA approval requirements and
adequate directions for use, it is subject to cGMP requirements and will be inspected by the FDA
according to a risk-based schedule.
Paddy Deighan J.D. Ph.D
http://www.medicalandspaconsulting.com
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