Senate Bill Gains Major Support to Increase FDA Muscle on Drug Compounders
April 29th, 2013 // 12:52 pm @ jmpickett
Updated Daily – Read our latest FDA, cGMP Compliance News
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.
- May 30 – Audit Your Lab Like an FDA Auditor – A Roadmap to cGMP Lab Compliance
- April 30 – How to Prepare Yourself for 21 CFR Part 11 Inspections
- May 1 – Avoiding Warning Letter Disasters With a Strong cGMP and GCP Quality Agreement
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.
Sen. Tom Harkin noted that this proposed legislation would be a big step ahead to protect the public from compounded drugs that are not safe.
The meningitis outbreak last year was bad, with 730 cases of the illness and 53 deaths. These were found to have been caused by violations of cGMPs at New England Compounding Center. That outbreak caused a major discussion in the country about how much authority FDA has to oversee these pharmacies that actually are acting more like large pharmaceutical companies in practice.
FDA stated that several rulings by the US Supreme Court had weakened authority over compounders. FDA did not that action would be involved against compounders that made large quantities of drugs that did not have a patient prescription and were shipping products across a state line. But, FDA did fail to follow up on a poor 2002 NECC audit and also a warning letter to the company.
Upcoming FDA cGMP Expertbriefings.com Webinars for 2013 include:
- May 30 – Audit Your Lab Like an FDA Auditor – A Roadmap to cGMP Lab Compliance
- April 30 – How to Prepare Yourself for 21 CFR Part 11 Inspections
- May 1 – Avoiding Warning Letter Disasters With a Strong cGMP and GCP Quality Agreement
- May 2 – Avoid the CDRH eCopy Confusion – How to Prepare a Compliant eCopy Submission
- May 7 – FDA Recall Chief Update – How to Design a Bulletproof Recall Strategy
- May 13 – Breaking Regulatory Update for Life Science Firms – UFA Requirements for eCTDs
- May 14 – How to Effectively Source OTC, Generics and APIs from Indian Pharma Manufacturers
- May 15 – FDA Chief Counsel Report – How to Deal With and Avoid Warning Letters
- May 16 – Spend $500K on Compliance or $300 Million on Consent Decree? – Essential cGMP Compliance Tips for Sr. Management
- May 30 – The Essentials of Complaint Handling and Post Market Management – How to Comply With Global Regulatory Requirements
