Draft bill gives FDA oversight of sterile compounding manufacturers


Legislation would create a new class of drug makers and strengthen FDA oversight

A draft bill that aims to address regulatory gaps in oversight of pharmaceutical compounding would give the FDA authority to regulate compounding manufacturers that make sterile products without, or in advance of, a prescription and sell them across state lines, according to a statement by the Senate Health, Education, Labor, and Pensions (HELP) Committee.

The legislation, released April 26, makes a clear distinction between traditional compounding, which will continue to be regulated by state pharmacy boards, and compounding manufacturers who produce sterile products without a prescription and will be regulated by FDA.

“This legislation is a significant step forward in protecting the public from unsafe compounded products. By clarifying FDA authority over high-risk compounding practices, this bill will enhance protections for patients taking compounded drugs and help prevent crises like last year’s tragic meningitis outbreak,” said Senator Tom Harkin (D-Iowa), chairman of the Senate HELP Committee.

Last November, Congress held hearings to examine the facts surrounding the fungal meningitis outbreak that led to the deaths of more than 50 patients who received contaminated steroid injections that were prepared by the New England Compounding Center (NECC), in Framingham, Mass. More than 700 patients in 20 states were affected by the contaminated methylprednisolone. The failure of NECC to maintain sterility in the pharmacy led to the outbreak.

The American Society of Health-System Pharmacists (ASHP) issued a statement, saying that it was encouraged by the various provisions within the compounding bill.

Some provisions within the bill include:

Establishment of a clear boundary between traditional compounders and compounding manufacturers;

Clarification of the fact that compounded drugs are new drugs subject to the Federal Food, Drug, and Cosmetic Act, and specifications of the provisions of law applying to traditional compounders and compounding manufacturers;

FDA’s role in oversight of compounding manufacturers, establishment of an annual fee to defray costs of compounding oversight, and responsibility of manufacturers to pay costs for reinspections;

Preservation of states’ primary role in oversight of traditional pharmacy;

Enhancement of bulk chemical requirements for ingredients used in all compounded products;

Communication among states and increased communication between states and the FDA.

“Based on a preliminary assessment, ASHP is pleased with the direction the Senate is heading on this very important legislation that includes key provisions we have advocated for over the past six months,” said ASHP CEO Paul W. Abramowitz, PharmD, FASHP. “We are particularly pleased that the committee recognizes the role of the states in overseeing traditional compounding, including that which occurs in hospitals and health systems, while creating a new definition of a ‘compounding manufacturer’ that would be overseen by the FDA.”

ASHP plans to review the draft thoroughly and submit comments by the May 3 deadline.


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