Doctor concerned with health care law

Breaking news and expert analysis on legal and compliance issues

[Back To Home][Back To Archives]

From Health Law Daily, November 18, 2013

Drug compounding bill heads to the White House for signature

By Harold M. Bishop, JD

On Monday, the Senate passed the Drug Quality and Security Act by voice-vote. H.R. 3204 was introduced by Fred Upton (R-Mich.) after the recent fungal meningitis outbreaks caused by unsanitary conditions at a compounding drug factory, which resulted in 64 deaths.Title I of the bill is entitled the Drug Compounding Act and Title II is entitled the Drug Supply Chain Security Act. The legislation will make it easier to trace drugs throughout the supply chain, broadens the FDA’s authority to regulate the manufacturing of compound drugs, and contains anti-counterfeit drug provisions.

Compounding Quality Act. Title I amends the Food, Drug, and Cosmetic Act (FDC Act) with respect to the regulation of compounding drugs. It exempts compounded drugs from new drug requirements, labeling requirements, and track and trace requirements if the drug is compounded by or under the direct supervision of a licensed pharmacist in a registered outsourcing facility.

It also: (1) establishes annual registration requirement for any outsourcing facility; (2) requires a facility to report biannually to HHS on what drugs are compounded in the facility; (3) requires submission of adverse event reports; (4) subjects compounding facilities to a risk-based inspection schedule; (5) prohibits the resale of a compounded drug labeled “not for resale,” or the intentional falsification of a prescription for a compounded drug; (6) deems a drug to be misbranded if the advertising or promotion of a compounded drug is false or misleading in any particular; and (7) revises compounding pharmacy requirements to remove prohibitions on advertising and promotion by compounding pharmacies and removes the requirement that prescriptions filled by a compounding pharmacy be unsolicited.

Under Title I, HHS is required to: (1) publish a list of drugs presenting demonstrable difficulties for compounding that are reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug, taking into account the risk and benefits to patients; (2) convene an advisory committee on compounding before creating the list; (3) assess an annual establishment fee on each outsourcing facility and a reinspection fee, as necessary; (4) receive submissions from state boards of pharmacy (a) describing any disciplinary actions taken against compounding pharmacies or any recall of a compounded drug, and (b) expressing concerns that a compounding pharmacy may be violating the FFDCA.

Drug Supply Chain Security Act. Title II establishes requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain. Specifically, it establishes requirements for drug manufacturers, wholesalers, dispensers, and repackagers to ensure that all prior transaction information is provided at each transfer of ownership.

It also requires: (1) a manufacturer, wholesale distributor, dispenser, and repackager, in the event of a recall or for the purpose of investigating a suspect product or an illegitimate product, to provide within a reasonable time the applicable transaction documentation upon request by HHS or other appropriate federal or state official; (2) a manufacturer or repackager to affix or imprint a product identifier on each package and homogenous case intended to be introduced in a transaction into commerce except for products that are required to have a standardized numerical identifier; (3) a manufacturer, wholesale distributor, dispenser, or repackager to ensure that each of its trading partners is authorized; (4) a manufacturer, wholesale distributor, dispenser, and repackager to implement systems to (a) investigate suspect products and (b) handle illegitimate products, including through quarantine, disposal, and appropriate notice to HHS and, as necessary, trading partners; and (5) manufacturers, wholesale distributors, and repackagers to verify returned products before further distribution.

Under Title II, HHS is required to establish: (1) standards for the exchange of transaction documentation, which shall include transaction information, transaction history, and transaction statements; (2) processes to (a) provide waivers of requirements, including for undue economic hardship or emergency medical reasons; (b) provide exceptions to requirements relating to product identifiers if a product is packaged without sufficient space to bear the information; and (c) determine other products or transactions that should be exempt from the requirements of the Act; (3) projects and hold public meetings to enhance the safety and security of the pharmaceutical distribution supply chain; and (4) standards for the licensing of wholesale distributors and third party logistics providers.

The bill passed the House in September, but had been filibustered by Sen. David Vitter (R-La.) in an effort to get an amendment vote on his Show Your Exemption Act, which would force members of Congress to disclose which of their staff they have exempted from enrolling in the health care exchange.

MainStory: TopStory DrugNews FDCActNews DrugBiologicalNews LabelingNews MisbrandingNews PrescriptionDrugNews SafetyNews

Health Law Daily

Introducing Wolters Kluwer Health Law Daily — a daily reporting service created by attorneys, for attorneys — providing same-day coverage of breaking news, court decisions, legislation, and regulatory activity.


A complete daily report of the news that affects your world

  • View full summaries of federal and state court decisions.
  • Access full text of legislative and regulatory developments.
  • Customize your daily email by topic and/or jurisdiction.
  • Search archives for stories of interest.

Not just news — the right news

  • Get expert analysis written by subject matter specialists—created by attorneys for attorneys.
  • Track law firms and organizations in the headlines with our new “Who’s in the News” feature.
  • Promote your firm with our new reprint policy.

24/7 access for a 24/7 world

  • Forward information with special copyright permissions, encouraging collaboration between counsel and colleagues.
  • Save time with mobile apps for your BlackBerry, iPhone, iPad, Android, or Kindle.
  • Access all links from any mobile device without being prompted for user name and password.