BETHESDA, MD 14 June 2013—The Senate Health, Education, Labor and Pensions (HELP) Committee on May 22 passed legislation to improve the safety of sterile compounding and give FDA explicit authority over a new class of drug makers called compounding manufacturers.
Senate bill 959,
the Pharmaceutical Compounding Quality and Accountability Act, defines compounding manufacturers as entities that compound sterile drug products without a prescription and sell them across state lines or offer to do so. Under the terms of the act, compounding manufacturers would be regulated by FDA and have to follow many of the procedures expected of traditional drug manufacturers, which would remain under FDA's purview.
The act would leave traditional compounding under state supervision. So-called anticipatory compounding by traditional compounders would be permitted if the practice is allowed under state law. Anticipatory compounding would involve "limited quantities" of medication made for a patient when there is a history of the medication's use and the pharmacy and prescriber have an established relationship with the patient.
The bill's next stop is to the full Senate for consideration. ASHP stated its support (PDF) for the Senate's bill and urged the House to draft and pass similar legislation.
Janet Woodcock, chief of FDA's drugs division, on May 9 had urged Congress to act on the bill to help protect patients from tragedies such as last year's outbreak of fungal infections that were blamed on products made by the New England Compounding Center (NECC).
"In the absence of changes, these tragedies will happen again. There is no doubt about this," Woodcock said.
Exemptions for hospitals. The act states that pharmacies within health systems would not be considered compounding manufacturers. Hospitals would remain regulated as traditional pharmacies, even if they ship medications to out-of-state facilities that are part of the health system.
Under the terms of the act, any entity other than a hospital or health system that pools sterile products or repackages sterile, preservative-free vials would also be classified as a compounding manufacturer.
These exemptions are opposed by the International Academy of Compounding Pharmacies (IACP). IACP Chief Executive Officer David G. Miller, during May 9 testimony before the HELP Committee, pressed for equal treatment of all pharmacies that perform the same drug manipulations as compounding manufacturers.
Kasey K. Thompson, vice president of ASHP's office of policy, planning, and communications, called the idea of grouping hospitals with compounding manufacturers "an apples-to-oranges comparison."
"A hospital is a patient care entity that's preparing a product or doing procedures for the patients they serve. They're not preparing a large amount of product and storing it in a warehouse for long periods of time. They're preparing that product in clean-room conditions, taking it to the floor, administering it to that patient by licensed health care professionals who are accountable for that patient," Thompson said during the hearing.
National Association of Boards of Pharmacy Executive Director Carmen P. Catizone also agreed with the exemption for hospitals. He noted that hospitals are closed systems that generate a patient-specific medication order for each drug dose and check for contraindications, drug interactions, and other potential problems before administering the medications.
If adverse events occur, hospitals have systems in place to identify the cause, contain the problem, and take appropriate actions to protect patients, Catizone said.
Compounded drugs. Hospitals have a special interest in the regulation of sterile compounding because they both prepare such products and purchase them from compounding pharmacies.
A recent federal survey of 298 acute care hospitals found that 92% of respondents had used compounded sterile products last year. Overall, according to the survey, 95% of hospitals said they made at least some compounded sterile products onsite.
But 79% of hospitals reported that they purchased at least some compounded sterile products from outside pharmacies.
The survey respondents reported that over 99% of compounded sterile products were prepared from sterile ingredients. Nonsterile-to-sterile compounded drugs accounted for 1% of compounded products used at the hospitals, and roughly a third of them made those products onsite.
Medications made by NECC that were associated with fungal infections were produced using nonsterile-to-sterile compounding practices, according to the report.
The report stated that 56% of acute care hospitals either changed their practices for the outsourcing of compounded sterile products or planned to do so in response to the outbreak. About 80% of hospitals said they had decreased the outsourcing of compounded sterile products, and half said they had increased their capacity to produce these medications inhouse.
Compounding manufacturers. According to a HELP committee memo, the initial version of the Senate bill "clarifies a national, uniform set of rules for compounding manufacturers, while preserving the states' primary role in traditional pharmacy regulation."
Specifically, the act would require compounding manufacturers to register with FDA each year and report to the agency twice annually the identity and amount of all compounded products sold in the preceding six months.
All compounding done by compounding manufacturers would be directly overseen by a pharmacist who is licensed in the state where the compounding takes place.
Unlike traditional compounders, compounding manufacturers would be required to follow current good manufacturing practices (cGMPs) that relate to the methods, facilities, and controls used in the manufacture, processing, packaging, and holding of drug products. Compounding manufacturers and traditional compounders would remain exempt from cGMP requirements for drug labeling and new drug applications.
Compounding manufacturers would be required to provide specific information on product labels, including the statement "This is a compounded drug."
The act would prohibit wholesalers from selling any compounded drugs and allow compounders to sell their products only to the health care entities that treat the patients who will use the drugs. The products must be labeled "Not for resale."
The act would require compounding manufacturers to investigate adverse events and report them to FDA within 15 days after the compounding manufacturer learns of the event. And FDA would be given explicit authority to inspect the compounding manufacturer's facilities and examine its records.
FDA officials had asked for these provisions during multiple appearances before Congress.
At presstime, the bill had not been scheduled for action on the Senate floor. HELP Committee Chairman Tom
Harkin of Iowa pledged to work with Senate leaders to schedule a vote on the bill "in a timely manner."
A video recording of Thompson's appearance before the committee is available at www.ashpmedia.org/video/Compounding/vid/videos.htm.