On Friday, April 26, 2013, the Senate Committee on Health, Education, Labor and Pensions (HELP) began to consider a draft bill to increase the regulation of compounding drugs. Under the proposed legislation, mixing, reconstituting, or other activities performed according to the manufacturer’s directions would not be considered compounding. The bill would distinguish between traditional compounders, who compound drugs to fill orders for identified patients, and compounding manufacturers, who prepare drugs for shipment in interstate commerce. The requirements would apply to compounded drugs for human beings or animals. The HELP committee is accepting comments on the proposed bill at email@example.com until 6:00 pm on May 3, 2013.
The bill would amend sec. 503A of the Food, Drug and Cosmetic Act (FD&C Act) to define traditional compounders as licensed physicians or veterinarians or pharmacists who prepare limited quantities of a drug for an identified patient; the pharmacists must be working in a licensed pharmacy. A traditional compounder may only compound drugs on receipt of a prescription for an identified individual patient. If there is an established relationship between the physician or patient and the compounding pharmacist, the drug may be prepared before the prescription is presented. When drugs are compounded for animals, the identified patient may be a specific herd or flock.
The amendment to FD&C Act sec. 503A would define compounding manufacturers as entities that compound sterile drugs without a prescription order and introduce the drugs into interstate commerce or who repackage sterile drugs by pooling them or using single-dose vials. Entities that are part of a health system and prepare drugs in accordance with FD&C Act sec. 506F, who prepare drugs to be dispensed within the system and otherwise meet the definition of a traditional compounder, will not be considered compounding manufacturers.
New requirements would be imposed on compounding manufacturers. They will be required to register with the Secretary of the Food and Drug Administration (FDA) and to pay establishment fees beginning in fiscal year (FY) 2015. The establishment fee will be $15,000 per establishment for FY 2015 and will be adjusted thereafter. Small businesses will pay one-third of the fee. The FDA will charge compounding manufacturers reinspection fees. They also will have to submit reports to the FDA every six months listing the identification number, strength, and quantity of the drugs they have sold. Compounding manufacturers must be supervised by a licensed pharmacist. In addition, a compounding manufacturer who becomes aware of a serious adverse experience under FD&C Act sec. 505-1(b) must report it to the Secretary within 15 calendar days and must maintain records for ten years.
According to the draft bill, the FDA would be required to promulgate regulations designating acceptable bulk drugs and the applicable standards and identifying complex dosage forms or biological that may not be compounded. In promulgating regulations, the Secretary must publish a notice of proposed rulemaking and allow at least 60 days for comment; the agency may not use an interim final rule. The final rule must be published at least 30 days before its effective date.