Today, we're taking a key step forward in implementing the Drug Quality and Security Act (DQSA) and section 503B of the Federal Food, Drug, and Cosmetic Act. Among other things, these provisions limit the bulk drug substances that outsourcing facilities can use in compounding. It directs the FDA to develop a list of bulk drug substances for which there is a clinical need - the 503B bulks list.
Today, we're issuing a critical policy document that addresses how that list will be formulated, and what bulk drug substances the outsourcing facilities can use to compound from drugs.
Compounding can be critical for advancing the health of patients who have specific medical needs that cannot be met by FDA-approved drugs. However, because compounded drugs are not FDA-approved and do not undergo premarket review by the FDA for safety, effectiveness and quality; they also present a greater risk to patients than FDA-approved drugs. This was 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 who had used a compounded drug for injection that was supposed to be sterile, but became contaminated.
In response to that public health tragedy, Congress enacted the DQSA in 2013 to enhance the safety and quality of these medicines. Advancing the FDA's compounding program is a high priority for the agency. We're fully committed to implementing the DQSA requirements in a way that preserves access to compounded drugs for patients who have a medical need for them, while protecting patients from poor quality or otherwise unsafe compounded drugs that could cause them serious harm.
The draft guidance we're releasing today is one part of a comprehensive policy framework. In January, we released our compounding policy priorities plan, which lays out how the agency will implement, over the course of 2018, certain key provisions of DQSA and other requirements of the law relevant to compounders. The plan is comprised of a series of draft and final guidance documents, proposed and final rules, and a revised draft memorandum of understanding (MOU) between the FDA and states.
Today's draft guidance is a significant milestone in our work to implement that compounding priorities plan. The new draft guidance ("Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act"), issued for public comment, discusses the FDA's interpretation of the statutory phrase "bulk drug substances for which there is a clinical need," as well as the factors and processes that the FDA proposes to use when evaluating whether to include a bulk drug substance on the list of bulk drug substances that outsourcing facilities may use in compounding drugs.
Outsourcing facilities are subject to more stringent FDA oversight than traditional pharmacy compounders and can compound drugs in one of two ways. First, by starting from an FDA-approved drug product, the outsourcing facilities may prepare compounded drugs by altering the FDA-approved drug. This can be done, for example, by diluting the FDA-approved drug or changing the dosage form, perhaps by crushing an approved tablet to make an oral solution. The second way outsourcing facilities compound drugs is by starting from a bulk drug substance. An outsourcing facility may do this because an attribute of the alternative, FDA-approved drug product makes it inappropriate or unsafe for the patient.
However, as our draft guidance explains, compounding from bulk drug substances generally presents greater risk to patients than compounding from FDA-approved drugs. There are fewer assurances of safety and quality associated with a bulk drug substance than with an FDA-approved drug. Compounding from bulk drug substances also involves more numerous and complex steps than compounding from approved drugs. This process can introduce increased risk for compounding errors or contamination.
Further, compounding drugs using bulk drug substances, when the use of an FDA-approved drug or a drug compounded using an FDA-approved drug would meet patients' medical needs, can undermine the drug approval process by reducing the incentive for drug manufacturers to seek approval of brand or generic drugs. These issues have informed our views on how ...
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