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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, February 4, 2013
Alabama Board of Pharmacy Statement on Compounding Hydroxyprogesterone Caproate
Board Statement on Compounding Hydroxyprogesterone Caproate
On June 15, 2012, Food and Drug Administration (FDA) issued a statement indicating it will apply its normal enforcement policies for pharmacies compounding hydroxyprogesterone caproate. In line with FDA’s statement, licensees are reminded that 20 CSR 2220-2.200(9) provides:
Compounding of drug products that are commercially available in the marketplace or that are essentially copies of commercially available Federal [Food and] Drug Administration (FDA) approved drug products is prohibited. There shall be sufficient documentation within the prescription record of the pharmacy of the specific medical need for a particular variation of a commercially available compound.
Accordingly, licensees must have sufficient documentation of a specific medical need prior to compounding hydroxyprogesterone caproate in the future.
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Saturday, February 2, 2013
FDA to Let Caronia Stand, Will Factor Ruling Into Guidance
The FDA will not seek further review of the 2nd Circuit’s decision in U.S. v. Caronia as the agency doesn’t view the decision as a significant threat to its misbranding enforcement drive. However, the controversial ruling will likely factor into guidance development, FDA officials said Jan. 30.
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Republicans: FDA uncooperative in Massachusetts meningitis probe New England Compounding Center probe
http://www.wcvb.com/health/Republicans-FDA-uncooperative-in-Massachusetts-meningitis-probe/-/9848730/18379562/-/format/rsss_2.0/-/9co67jz/-/index.html
NECC SET FOR RECORD PROFITS BEFORE OUTBREAK
http://pbmauditlawyers.blogspot.com/2013/01/federal-appellate-decision-involving.html
Federal Appellate Decision Involving Off-Label Drug Marketing Could Expand the Ability of Pharmacies to Market Compound Prescriptions
By Jonathan E. Levitt, Esq. and Jesse C. Dresser, Esq.
Last week, the U.S. Court of Appeals for Second Circuit ruled that the Food and Drug Administration (FDA) cannot prosecute pharmaceutical manufacturers’ representatives for speech promoting the lawful, off-label use of an FDA-approved drug. The decision, United States v. Caronia, could dramatically expand the free-speech rights of pharmaceutical companies and compounding pharmacies alike. Compound marketers could enjoy greater leeway to share unapproved information.
The case involved a pharmaceutical marketing representative, Alfred Caronia, who was an employee of Jazz Pharmaceuticals. Jazz Pharmaceuticals manufactures Xyrem, a powerful central nervous system depressant used to treat narcolepsy patients who experience cataplexy (a condition associated with weak or paralyzed muscles) and excessive daytime sleepiness (EDS). The FDA recorded Caronia marketing the drug for off label uses. He stated to a physician that, in addition to cataplexy and EDS, Xyrem could be used to treat insomnia, Fibromyalgia, periodic leg movement, restless leg syndrome, MS, Parkinson’s disease and other sleep disorders. Caronia additionally marketed the drug to treat patients under the age of 16 (despite the fact that the Xyrem had only been approved by the FDA to treat patients over the age of 16).
Caronia was convicted of violating Sections 331(a) and 333(a)(1) of the Food, Drug and Cosmetic Act (FDCA). In those sections, the FDA prohibits the introduction of a misbranded drug into interstate commerce. He was sentenced to one year’s probation. Caronia appealed the conviction to the Second Circuit.
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