FDA steps up action to ensure quality of compound drugs

The US Food and Drug Administration (FDA) wants to ensure the quality of compound drugs and the public’s access to them by seeking closer partnership with state authorities.

Compounding medicines can provide important public health opportunities and implementing the compounding provisions of the law was an important priority for the agency, it said in a statement.

"We recognise that in delivering on implementation commitments, we must balance the need to preserve access to appropriately-compounded drugs for patients who have a medical need for these products with the need to help protect patients from poor quality compounded drugs that could cause harm," said the agency.

The FDA planned to build on steps taken over the past year – set out in the 2018 Compounding Policy Priorities Plan – by unveiling new polices, over the next few months, relating to insanitary conditions at compounding facilities and a risk-based approach to current good manufacturing practice (CGMP) requirements for outsourcing facilities.

State authorities played a key role in cutting the risks associated with compounded drugs, while ensuring appropriate access, according to the FDA. To strengthen the partnership, the agency issued a revised draft memorandum of understanding (MOU) between the FDA and the states.

Risks associated with compounded drugs

"The goal of the MOU is to collaborate with the states so that, working together, we can have the greatest public health impact while also maximising our resources," the agency said in a statement.

"Toward these goals, the revised draft MOU addresses patient access concerns previously raised by stakeholders, while retaining critical safety provisions. Today’s [September 7] action is also an important step to increase our collaboration with the states to maximise resources and our collective public health impact, and it marks a significant milestone in the agency’s implementation of federal law on compounding."

Compounded drugs were said to pose unique risks. They were not FDA approved, neither do compounded drugs undergo pre-market review for safety, effectiveness or quality. Also,  if a compounder distributed drugs to several states, it can be difficult to gather information about possible adverse events associated with those drugs, link them to the compounder, and undertake coordinated action to address potentially serious public health problems.

"These risks were illustrated by the 2012 nationwide fungal meningitis outbreak. This tragic outbreak led to more than 750 cases of illness and the deaths of 64 individuals," said the FDA. "They had used a compounded drug for injection that was supposed to be sterile but had become contaminated before distribution to patients and providers."

The revised draft MOU invites states to identify compounders that distribute more than 50% of their total prescription orders for compounded drugs interstate and report information to the FDA about those compounders.

That included information about the volume of compounded drugs distributed between states and the number of states in which the compounder is licensed. The information will help both the FDA and the states to develop risk-based oversight priorities for the purpose of providing the greatest public health impact, said the agency.

States that agree to the MOU will investigate complaints and advise the FDA when they receive reports of serious adverse drug experiences or serious product quality issues, such as drug contamination. "We anticipate the MOU will help to facilitate increased collaboration between the FDA and the states that sign it. Working together, we can help promote safe compounding practices and better address emerging public health concerns that may affect patients," said the agency.

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