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
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| 12/21/2017 | 3010166765 | Healix Infusion Therapy, Inc. | FMD-145 Letter | TX | Producer of Sterile Drug Products | 01/12/2018 |
| 12/21/2017 | 3004497213 | Oakdell Pharmacy, LLC | FMD-145 Letter | TX | Producer of Sterile Drug Products | 01/12/2018 |
| 12/18/2017 | 3013556857 | Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy | 483 | CA | Producer of Sterile Drug Products | 01/12/2018 |
| 12/22/2017 | 3004578635 | The Wellness Center Pharmacy, Inc., dba Designer Drugs | 483 | TN | Producer of Sterile Drug Products | 01/10/2018 |
| FDA Takes Prudent Tact In Response To Endo Compounding Lawsuit
FDA appears to be framing its policy on compounding of bulk substances by outsourcers differently to the courts than it is to Congress, one compounding attorney commented after reading the agency response to a lawsuit seeking to block FDA's interim policy on 503B compounding. However, multiple ...
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| Fla. Compounding Pharmacy, Execs Escape Rep's FCA Claims
Law360, Miami (January 11, 2018, 6:22 PM EST) -- A federal judge on Wednesday threw out a former sales representative's amended False Claims Act suit against a Florida compounding pharmacy and its top executives, finding her pleadings insufficient on claims outside of an accusation of overbilling ...
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The U.S. Food and Drug Administration announced today that it is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old because the serious risks of these medicines outweigh their potential benefits in this population. After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older. Labeling for the medications also is being updated with additional safety information for adult use – including an expanded Boxed Warning, the FDA’s most prominent warning ‒ notifying about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone. Continue reading...
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| 12/21/2017 | Continental Manufacturing Chemist, Inc. | Detroit District Office | CGMP/Drug Products/Adulterated | Not Issued * |
| 12/21/2017 | Continental Manufacturing Chemist, Inc. | Detroit District Office | CGMP/Drug Products/Adulterated | Not Issued |
| 01/03/2018 | AuroMedics Pharma LLC | Ampicillin and Sulbactam for Injection USP | Presence of glass particles | AuroMedics Pharma LLC |
| FDA aims to strengthen oversight of compounded drug manufacturing
The Food and Drug Administration aims to "reinvigorate" efforts to improve production standards for compounded drug products, highlighting continued safety concerns with the industry practice in a recent update published in the New England Journal of Medicine. Since a deadly meningitis outbreak in .
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| International Academy of Compounding Pharmacists Announcement
HOUSTON, Jan. 5, 2018 /PRNewswire/ -- The International Academy of Compounding Pharmacists (IACP), representing nearly 4,000 pharmacists, technicians, students and members of the compounding community who focus upon the specialty practice of pharmacy compounding, today announced
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