By Karla L. Palmer –
In the wake of the New England Compounding Center (“NECC”) matter, on November 2, 2012, Congressman Edward J. Markey (D-MA), senior member of the Energy and Commerce Committee, introduced legislation that will attempt to strengthen federal oversight of compounding pharmacies. NECC, which is located in Congressman Markey’s congressional district, is the alleged source of injectable steroids that have led to 28 deaths and 377 illnesses to date across at least 19 states. Announcing the proposed legislation, Congressman Markey stated that “[c]ompounding pharmacies have been governed by fragmented regulations for too long, leading to the worst public health disaster in recent memory.” As stated in the bill and described in the Congressman’s press release announcing the bill, the proposed legislation, titled the Verifying Authority and Legality in Drug Compounding Act of 2012 (“VALID”) (H.R. 6584), will amend section 502A of the Federal Food Drug and Cosmetic Act (“FDCA”)(21 U.S.C. § 353a) as follows:
- Preserve state regulatory authority for traditional small compounding pharmacy activities. Among other requirements, the drug must be compounded for an individual patient based on the receipt of a valid prescription or a notation approved by the prescribing practitioner that the compounded product is necessary for the identified patient. However, this requirement may be waived under certain limited circumstances set forth in the bill;
- Ensure that compounding pharmacies (specifically those using bulk substances) that are operating as drug manufacturers are regulated by FDA as drug manufacturers (under section 510 of the FDCA (21 U.S.C. § 360));
- Allow compounding pharmacies with a legitimate reason to compound drugs before the receipt of a valid prescription to request a waiver to enable them to do so;
- Allow FDA to waive the requirement to compound drugs solely for individual patients with valid prescriptions in the event of a drug shortage or to protect the public health or well-being, but that waiver may not exceed one year unless the Secretary determines under limited circumstances that the waiver must continue beyond that time period;
- Allow FDA to waive the requirement to compound drugs only if they are not copies of commercially available drugs if doing so is necessary to protect public health or well-being,
- Increase transparency to the public by mandating that compounded drugs are labeled to ensure that recipients know that the drugs have not been tested for safety and effectiveness. The Act also mandates publication not later than one year after the law’s enactment of a “Do Not Compound” list of unsafe or ineffective drugs, which list will be made available on the FDA’s website, and will be transmitted by the Secretary of HHS to state agencies with responsibility for regulating compounding;
- Any drug product compounded in accordance with the Act shall include the following statement: “This drug has not been tested for safety and effectiveness and is not approved by the FDA. Serious adverse reactions to this drug should be reported to the pharmacy where it was received and the FDA at _____”. The blank shall “specify a phone number and a Web site….”. If the compounded drug product does not contain this statement, then it is deemed misbranded (distribution of misbranded drugs is prohibited by federal law);
- Pharmacists and pharmacies compounding a drug product are required to report to the Secretary of HHS any adverse event associated with the use of such compounded product within ten days after becoming aware of such an event. Furthermore, if the pharmacist or pharmacy becomes aware of any information concerning “bacteriological, fungal, or other contamination; any significant chemical, physical, or other change; or any deterioration of a compounded drug product” that has been distributed and that “could cause serious injury or death,” the pharmacist must report no later than five calendar days such information to the Secretary; and
- The Secretary must promulgate final regulations to carry out the Act within one year after enactment.
Although not detailed in the press release, the draft legislation proposes certain “waivers” of the requirement that a specified drug product must be compounded for an individually identified patient, but waivers are not available to those pharmacies that would be required to be registered as drug manufacturers. Pharmacies or pharmacists eligible for a waiver would include: (1) “any pharmacy or pharmacist within a hospital system that is compounding drug products exclusively for dispensing to patients within that hospital system;” (2) a pharmacy or pharmacist that compounds sterile drug products; and (3) a “pharmacy or pharmacist that compounds drug products in limited quantities before the receipt of a valid prescription for an individual patient who is located in the same state as the pharmacy or pharmacist, based on a history of the pharmacy of pharmacist receiving such valid prescription.” On a limited basis, and pursuant to a “Memorandum of Understanding” between a state and the Secretary of HHS, the Secretary may authorize a state to grant waivers to pharmacies located within their state under certain limited, to-be-determined circumstances. Those waivers would be state-specific and applicable only to compounded drugs sold or dispensed within that state. Any pharmacy facility compounding drug products pursuant to a waiver is subject to inspection under section 704 of the FDCA (21 U.S.C. § 374). Congressman Markey claimed that the VALID Compounding Act ends the “regulatory black hole” often identified with pharmacy compounding by giving the "FDA new, clear authority to protect patients and oversee these companies.” Congressman Markey’s full press release announcing the legislation is available here. A one-page description of the Act, prepared by Markey’s office is available here.