Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
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Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
The SC ruling did not strip FDA of powers--the 1997 law (Section 503A) for which the commercial free speech restriction was found unconstitutional also provided exemptions to three provisions of the FFDCA, originally pushed for by the compounding industry, and for which then Commissioner David Kessler, MD warned that the legislation would lead to a "shadow industry" of manufacturing under the guise of compounding. The overturn of FDAMA actually resulted in a potentially stricter enforcement situation for pharmacies not meeting conditions for exemptions (where 503A null and void, full force of FFDCA could reign down). If you read the entire SC decision, you will see that the court believed FDA could use alternative enforcement mechanisms to get at the issues that the speech restrictions had intended to cover. In the dissenting opinion, Justice Breyer points out the reality for FDA: easier said than done.
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The SC ruling did not strip FDA of powers--the 1997 law (Section 503A) for which the commercial free speech restriction was found unconstitutional also provided exemptions to three provisions of the FFDCA, originally pushed for by the compounding industry, and for which then Commissioner David Kessler, MD warned that the legislation would lead to a "shadow industry" of manufacturing under the guise of compounding. The overturn of FDAMA actually resulted in a potentially stricter enforcement situation for pharmacies not meeting conditions for exemptions (where 503A null and void, full force of FFDCA could reign down). If you read the entire SC decision, you will see that the court believed FDA could use alternative enforcement mechanisms to get at the issues that the speech restrictions had intended to cover. In the dissenting opinion, Justice Breyer points out the reality for FDA: easier said than done.
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