09.18.14 Pharmacy - Meeting Minutes - Hawaii.gov
hawaii.gov/dcca/pvl/boards/pharmacy/.../140918%20%20min.doc.pdf
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
Tuesday, October 28, 2014
Minutes from 9/18/14 Hawaii Board of Pharmacy Meeting--discusses DQSA and office use
FDA Orders New Jersey Company to Destroy Unapproved Drug Products
Federal authorities have ordered a New Jersey company to destroy its unapproved products and stop further manufacturing and distributing them until the drugs receive Food and Drug Administration (FDA) approval. A federal judge from the US District Court for the Southern District of Ohio entered aconsent decree for a permanent injunction against the company, Ascend Laboratories of New Jersey. The unapproved drugs are as follows:
- Pramoxine-HC Otic Drops;
- Hydrocortisone Acetate Suppositories 25 milligrams;
- Urea Cream 39%;
- Urea Cream 40%; and
- Urea Lotion 40%
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