Rosen Quoted on FDA Warning Letters Issued to Drug Compounders

31 January 2014 Inside Health Policy News

Inside Health Policy

Partner David Rosen was quoted in an Inside Health Policy article on January 31, 2014 titled, “First DQSA Warning Letters Target Compounders Without Prescriptions.” The article discusses the two warning letters issued by the FDA to drug compounders in recent weeks chastising them for lacking patient-specific prescriptions. Rosen was quoted saying, “If you do not have an individual prescription for every patient for whom you compound, this is one way FDA is sending the message that you are not compliant with 503A at this time.”

Related Services

Insights

30th Annual Law of Product Distribution & Franchise Seminar
29 September | 7 & 20 October 2021
Milwaukee | Chicago | Dallas
7th National Telehealth Summit
4-5 October 2021
Miami Beach, FL
AHLA Fraud & Compliance Forum
21-22 September 2021
Baltimore, MD
2nd Clinical Trial Agreements Forum
16-17 September 2021
Online Livestream