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, December 22, 2014
How Strategies to Mitigate Drug Shortages Lead to Medication Errors Published Online: Sunday, December 21, 2014 -
Fierce Animal Health Top Stories
Today's Top Stories
1. Lilly's Elanco disputes local paper's allegations of unsafe pet meds
2. Zoetis hikes dividend under continued pressure from activist investor Ackman
3. New deer vaccine against mad-cow-like disease may help people too
4. Aratana Therapeutics starts new canine study; reports good results on another
5. Bayer casts off equine drugs with 'no strategic relevance' to Sanofi's Merial
1. Lilly's Elanco disputes local paper's allegations of unsafe pet meds
2. Zoetis hikes dividend under continued pressure from activist investor Ackman
3. New deer vaccine against mad-cow-like disease may help people too
4. Aratana Therapeutics starts new canine study; reports good results on another
5. Bayer casts off equine drugs with 'no strategic relevance' to Sanofi's Merial
Sunday, December 21, 2014
MA State Board of Pharmacy Complaint and Investigation of Royal Palm Specialty Pharmacy
Full text of "Royal Palm complaint and investigation"
Merial Comments: What Do Recent FDA Warnings to Equine Stomach Ulcer Product Manufacturers Mean?
From Merial – In late October, the U.S. Food and Drug Administration issued warning letters to multiple marketers of products claiming treatment of equine stomach ulcers, including:
- Horse Gold, Inc. – GastroMax3
- HorsePreRace – Omeprazole Oral Paste, Omeprazole/Rantidine Oral Paste
- Tri-Star Equine – Gastrotec
- Douglas J. Gordon, Teton Equine – UlcerCure OTC
- Cox Veterinary Laboratory, Inc. – Gastroade Xtra
- Ceva Animal Health Pty Ltd. – Omoguard Paste
- Abler, Inc. – AbGard, Abprazole, Abprazole Plus, Abler Omeprazole
- Multivet USA, Inc. – Gastro37 OTC
The FDA admonished all of them for promoting their products “for use in the mitigation, treatment or prevention of disease in animals.”1-8 When companies market their products for such use, they fall under the Federal Food, Drug and Cosmetic Act (FD&C Act) and therefore are considered drugs. None of these companies have obtained FDA approval of their products, meaning the products have not been evaluated for safety, effectiveness or quality.9
Second Question of the Day December 21, 2014 How many veterinary hospitals have in-house laboratories and compounding pharmacies like the one below? Will this be the new wave of the future for veterinary hospitals and possibly clinics to have their own in-house compounding pharmacies? Will clinics and hospitals for animals start to follow the business models of those for humans?
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