A bill introduced February 18, 2014 in the U.S. House of Representatives would require registered manufacturers and distributors of controlled substances identified under the Controlled Substances Act to perform criminal background checks and drug testing for employees with access to controlled substances.

The measure, “Ensuring Patient Access and Effective Drug Enforcement Act of 2013” (H.R. 4069), introduced by Rep. Tom Marino (R-PA), and co-sponsored by Rep. Marsha Blackburn (R-TN), reportedly with backing from the National Community Pharmacists Association, the Health Distribution Management Association, and the National Association of Chain Drug Stores, would require registrants, as a condition of registration, “(A) to obtain a criminal background check on each of the registrant’s employees who has or will have access to facility areas where controlled substances under the registrant’s possession or control are stored, such as a cage, vault, or safe; and (B) to perform drug testing on each such employee in accordance with the Federal and State law.”   (See Zachary Brennan, “New US House bill would require drug testing for pharma employees,” in-Pharma Technologist.com, William Read Media SAS, 26 Feb. 2014.)  The background checks would have to be conducted at least every two years, and upon hire, once the bill was enacted.  “Drug testing,” according to the proposal, “means testing designed to detect the illegal use of a controlled substance.”  Civil penalty provisions for failing to comply with the new mandates are included in the law.  The Attorney General would have authority to issue regulations and guidelines to carry out the amendments.

The bill also establishes the “Combating Prescription Drug Abuse Working Group,” a panel composed of government, pharma, drug wholesalers and retailers, health care industry and benefit plan representatives with broad mandate to further the measure’s aim of combating prescription drug abuse and diversion by creating a “more collaborative partnership between drug manufacturers, wholesalers, retail pharmacies and federal enforcement and oversight agencies,” http://www.in-pharmatechnologist.com reports.  It should also help protect consumers against disruption in the prescription drug supply chain, its sponsors maintain.

The bill’s reference to testing “in accordance with Federal and State laws” is not altogether clear.  No laws require the testing of such employees generally, so it appears this phrase refers to legal limitations on the types of tests that may be conducted and the testing procedures involved.  Such questions presumably would be answered in regulations following enactment.

The bill has been referred to the House Energy and Commerce, and Judiciary Committees.