Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Monday, December 1, 2014
Another Flashback: Compounding pharmacy should face deeper DEA investigation, says Rep. Markey
Wed, 2012-10-17 09:22 AM
By: Mark Rockwell
Meningitis outbreak
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The company that made the pain relieving steroid at the center of a growing fungal meningitis outbreak should face a deeper investigation into its activities with federally-controlled drugs, said a U.S. lawmaker.
Rep. Edward Markey (D-MA) on Oct. 16 urged the Department of Justice to begin a wider investigation into the Framingham, MA-based New England Compounding Center (NECC), to see it the firm violated laws and regulations for controlled prescription drugs. Markey said the company may have been improperly distributed nearly 1,000 controlled substances, including cocaine, morphine and ketamine that come under the purview of the Drug Enforcement Administration.
Another Flashback: Pharmacies Ill-Prepared For Potential DEA Crackdown
By Rachel Slajda
Law360, New York (September 18, 2012, 8:38 PM ET) -- Many pharmacies' day-to-day operations appear to violate the U.S. Drug Enforcement Administration's policies on controlled substances, and the pharmacies are risking their DEA registrations if the agency cracks down — a not-implausible scenario as the DEA battles widespread prescription drug abuse.
At issue is whether retail and compounding pharmacies can give controlled substances to doctors, rather than directly to patients. A prime example, pointed to by the industry and supportive lawmakers, is intrathecal pain medications that must be injected directly into a patient's spinal fluid.
At issue is whether retail and compounding pharmacies can give controlled substances to doctors, rather than directly to patients. A prime example, pointed to by the industry and supportive lawmakers, is intrathecal pain medications that must be injected directly into a patient's spinal fluid.
http://www.law360.com/articles/379346/pharmacies-ill-prepared-for-potential-dea-crackdown
Flashback: Pharmacy Law: Compounding Controlled Substance Medications for Equine Patients Joseph L. Fink III, BSPharm, JD Published Online: Thursday, January 1, 2009
A pharmacy specializing in veterinary pharmaceuticals had its registration revoked by the US Drug Enforcement Administration (DEA), because, in the view of the agency, it was engaged in "manufacturing" and "distributing" controlled substances, rather than "compounding" and "dispensing" them. The pharmacy challenged the interpretation at the level of an agency hearing as well as a request for reconsideration and, after the subsequent revocation of its DEA registration, sought judicial review of the action of the administrative agency. - See more at: http://www.pharmacytimes.com/publications/issue/2009/2009-01/2009-01-9982#sthash.y9h7BK3C.dpuf
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