June 25, 2024
Most prescription drugs are required to: undergo premarket approval to demonstrate safety and efficacy; be labeled with adequate directions for use so patients can safely use […]
June 25, 2024
What types of facilities should register with FDA as an outsourcing facility? The guidance states that only facilities that intend, upon registration, to comply with all […]
June 25, 2024
On January 8, 2014, FDA sent letters from Commissioner Hamburg regarding the pharmacy compounding provisions of the Compounding Quality Act to hospital and other health care […]
June 25, 2024
FDA has established a public docket to receive information, recommendations, and comments on matters related to the Agency’s regulation of compounding of human drug products under […]
June 25, 2024
MONTREAL —Tirzepatide (Mounjaro, Eli Lilly), the dual gastric inhibitory polypeptide–glucagon-like peptide 1 (GIP–GLP-1) receptor agonist that has shown significant benefits in diabetes and obesity, may also […]
June 25, 2024
Share on PinterestNew research finds that ketamine may be a more effective treatment for severe depression than electroconvulsive therapy. damircudic/Getty Images A new study compares ketamine […]
June 25, 2024
Please note: Section 503A has been amended by the Compounding Quality Act, as described in Section 106(a) of the Act, and these amendments are not reflected […]
June 25, 2024
TITLE I–DRUG COMPOUNDING SEC. 101. SHORT TITLE. This Act may be cited as the “Compounding Quality Act”. SEC. 102. VOLUNTARY OUTSOURCING FACILITIES. (a) In General.–Subchapter A of […]
June 25, 2024
BACKGROUND Pharmaceutical compounding is the combining, mixing, or altering of ingredients to create a customized medication for an individual patient in response to a licensed practitioner’s […]
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