FDA Wants More Regulatory Authority To Regulate Drug Compounding

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FDA Wants More Regulatory Authority To Regulate Drug Compounding

April 22nd, 2013 // 4:34 pm @

Latest cGMP and FDA Compliance News

The current FDA commissioner, Margaret Hamburg, MD, told a congressional panel last week that current FDA law and regulations are not well suited to the regulation of large pharmacies that conduct drug compounding.

The congressional panel is conducting an investigation into the fungal meningitis outbreak that killed dozens of people in 2012 throughout the US.

She said that sterile products that are made ahead of time without a prescription and shipped throughout the US need to be subjected to a high level of regulation that is established by FDA. She said that the regulations should be similar to current cGMP guidelines that are applicable to regular pharmaceutical manufacturers.

Hamburg testified in front of the House Energy and Commerce Subcommittee on Oversights and Investigations.

She said that FDA has been hampered in its job of protecting the public because current law has a lot of ambiguity about what the enforcement authority is in the area of drug compounding. It is not clear how much authority FDA has to regulate companies that make major quantities of sterile products before a prescription is received, and the product is shipped out of state after it is made.

This hearing at the House was the latest Congressional action after 2012’s deadly meningitis outbreak that was related to a contamination of compounded methylprednisolone acetate that was made by NECC. At this time, 50 people were killed and over 700 people were injured.

The Energy and Commerce Secretary, Rep. Fred Upton, asked if FDA had done its job properly. He wanted to know what FDA had done about NECC and Ameridose and what they knew about problems at both companies. FDA had had many warnings about NEC and there had been a lack of follow up from the agency on 483s and FDA warning letters.

Hamburg stated to the committee that the authority of FDA for compounders was damaged by many ambiguities in current law. One example is that the FDA Modernization Act of 1997. This act exempts compounded drugs from most aspects of oversight by FDA, but several courts have given different rulings on the case.

So, she said that FDA does not have that much knowledge about pharmacy compounders and only a limited ability to oversee what they do.

More cGMP Inspections of Drug Compounding Facilities

This year, FDA has sent auditors out to 30 compounding facilities in 19 states. They found many unsafe practices. For example:

  • Mysterious black particles in vials of medicine purported to be sterile
  • Mold and rust found in clean rooms where medications that were purported to be sterile were made
  • Employees handling sterile products in bare hands
  • Poor air filtration systems

Hamburg wrote in prepared testimony that there should be new GMP legislation for compounders that is based on a risk based strategy. It would distinguish between regular or traditional compounding and nontraditional compounding. Traditional compounding is where the drug product is made for one patient from an rx or order. Nontraditional compounding is where the products are made ahead of time without an Rx and are sent out of state.

Traditional compounding would be regulated by pharmacy boards in the states, as it is now. But nontraditional compounding would be handled by federal oversight. This would include FDA ability to take and test samples, and to check company records.

The new framework would be related to the 3 prong test that FDA has been talking about with Congress to indicate if the product is really sterile, is being shipped out of state and is being compounded before the Rx is received.

This 3 prong test however is not fully supported by the International Academy of Compounding Pharmacists, or IACP. They state that a new regulatory scheme is premature and this test could hurt the ability of the states to oversee compounding pharmacies.

On the other hand some compounders, such as PharMEDium Services, which is a producer of sterile compounds, thinks there should be new federal legislation to set up a new law for sterile compounders that makes them required to adhere to current cGMPs.

Upcoming FDA cGMP Expertbriefings.com Webinars for 2013 include:


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