Showing posts with label July 20. Show all posts
Showing posts with label July 20. Show all posts

Saturday, July 20, 2013

July 20, 2013 U.S. Rep Griffith Releases Revised Draft Bill Providing Federal Oversight over Compounding Pharmacies

While the Griffith Bill has a long way before it becomes law, it serves as a useful framework as regulators, pharmacies and other industry players continue grappling with the scope of federal oversight of compounding pharmacies.
On July 11, 2013, U.S. Representative Morgan Griffith (R-Va.) released a revised draft House Bill ("Griffith Bill"), updating the June 14, 2013, release of Senator Griffith's first proposed compounding bill, and signaling the latest push for the U.S. Food and Drug Administration's (FDA) regulation of compounding pharmacies. The Griffith Bill comes during a surge of federal oversight over compounding pharmacies, from issuing warning letters to compounding pharmacies, compounded drug recalls and other enforcement-related actions directed toward compounding pharmacies.
Unlike its Senate Bill predecessor, detailed in an earlier Duane Morris Alert, the Griffith Bill takes smaller incremental steps toward federal regulation of compounding pharmacies, which has traditionally been regulated by the states. Specifically, the Griffith Bill permits the regulation of compounding pharmacies to stay with the states; exempts compounded drugs from the Federal Food, Drug and Cosmetic Act (FDCA); and does not create a new "compounding manufacturer" regulatory category. While the Griffith Bill has a long way before it becomes law, it serves as a useful framework as regulators, pharmacies and other industry players continue grappling with the scope of federal oversight of compounding pharmacies.

Essential Elements of the Griffith Bill

Qualifications for FDCA Exemption (New Section 503A). The Griffith Bill proposes that drug products for human use should be exempted from Sections 501(a)(2)(B) (Current Good Manufacturing Practices), 502(f)(1) (adequate directions for use) and 505 (new drug application process), as long as certain conditions are met. Those conditions include:
  1. A drug product that is compounded pursuant to a patient-specific prescription order stating that a compounded product is necessary for the patient;
  2. As long as permitted by state law, a compounded drug is made before receipt of a patient-specific prescription order when the pharmacist has historically received valid prescription orders for compounded drug products and there is an established relationship between the licensed pharmacists or physician and the patient or prescriber; or
  3. As long as permitted by state law, pursuant to a non-patient-specific purchase order submitted by a healthcare provider, which assures that the drug will be administered by the healthcare practitioner within a healthcare setting and a patient-specific prescription order will be submitted within seven days.
continue to read at Duane Morris here