06/17/2016 | 3012360920 | W & C dba The Apothecary | 483 | MN | Producer of Sterile Drug Products | 06/24/2016 |
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
Friday, June 24, 2016
Arizona Abandons Use of Sedative as a Lethal-Injection Drug
ABC News-4 hours ago
Death penalty states refuse to disclose the sources of their drugs, though the sources are widely believed to be compounding pharmacies — organizations tha
Must Read Comment!! See IACP, the essence of compounding has always been tailoring to the individual patient, page 6: http://www.fda.gov/ohrms/dockets/ac/98/briefingbook/1998-3454B1_02_02-TAB1.pdf
Benefit-risk determinations for compounded drugs intended for populations have occurred during public health emergencies with FDA oversight, coordination and other expert input, for example, during pandemic flu for a pediatric dosage form experiencing shortages.
CQA Section 503B provides compounding exemptions to the FFDCA but adds certain public health protections, including FDA-GMP oversight and other requirements for sterile dosage forms intended for populations.
See IACP, the essence of compounding has always been tailoring to the individual patient, page 6: http://www.fda.gov/ohrms/dockets/ac/98/briefingbook/1998-3454B1_02_02-TAB1.pdf
Question of the Day July 23, 2016 61 Members of the House of Representatives signed a letter sent to the FDA urging FDA to Allow for Office-Use Drug Compounding in Pharmacies and claiming to know the intent of the full Congress and appearing to step in to the arena of judicial interpretation of legislation. If this was really the intent of the prior Congress who passed the DQSA why didn't every member who passed the legislation sign a letter to the FDA? Are the members of Congress who signed the letter violating separations of powers' principles? Why or why not?
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