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;
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Food and Drug Administration and Compliance Issues
Monday, April 29, 2013
Senate Bill Gains Major Support to Increase FDA Muscle on Drug Compounders Senate Bill Gains Major Support to Increase FDA Muscle on Drug Compounders April 29th, 2013 // 12:52 pm
Not long after a nationwide fungal meningitis outbreak that was found to have been caused by a drug compounding pharmacy, 35 US senators have put together draft legislation that would boost FDA oversight of compounders and also would have a list of strict requirements for these pharmacies to do business.
This bill would allow the agency to pinpoint certain types of drugs that may not be compounded. The bill also would make distinctions on acts that are associated with regular compounding, by putting restrictions on what is thought to be distribution wholesale of compounded products. Compounders also would be charged a fee of $15,000. This would help to increase FDA’s tight budget.
The bill also noted that compounders have to register with the agency and inform them of products they are making. Production must be supervised by a pharmacist at the state level and the company must comply with all FDA cGMP guidelines. All adverse events have to be reported. There has to be better communications with state pharmacy boards. And only ingredients that are in compliance with the US Pharmacopeia can be utilized.