Congressional Committee Approves Bill for Controlled Substances

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 02-16-2015 11:52


The Energy and House Committee of the US House of Representatives has approved a bill to improve the process for scheduling drugs regulated through the US Drug Enforcement Agency (DEA). The DEA is the federal agency responsible for classifying and setting manufacturing requirements for controlled substances. The bill was also co-introduced into the House Judiciary Committee. now goes to the full House for consideration.

H.R. 639, the "Improving Regulatory Transparency for New Medical Therapies Act," is a bipartisan measure authored by Health Subcommittee Chairman Joe Pitts (R-PA), Health Subcommittee Ranking Member Gene Green (D-TX), and full committee Ranking Member Frank Pallone (D-NJ).

“H.R. 639, as amended, seeks to improve the transparency and consistency of DEA’s scheduling of new FDA-approved drugs under the Controlled Substances Act, and its registration process for manufacturing controlled substances for use in clinical trials, said Rep. Pitts in a statement.

Specifically, the bill mends the Controlled Substances Act to require that the issuance, amendment, or repeal of a rule of the Attorney General for the classification of controlled substance and which has been recommended by the US Secretary of Health and Human Services to be placed in Schedule II, III, IV, or V, to begin no later than 120 days after receipt of written recommendations from the Secretary. It further requires the final rule to be issued no later than 60 days after the date on which both the public comment period has closed and the new drug is the subject of an approved new drug application, unless a hearing on the proposed rule is granted by the Attorney General.

The bill also requires the Attorney General to make a decision regarding registration to manufacture a controlled substance in Schedule III, IV, or V for use in a clinical trial within 180 days after receiving an application by either registering an applicant or showing cause serve why registration should be denied, revoked, or suspended.

The bill also requires the Attorney General, for the purposes of registration to manufacture a controlled substance in Schedule I or II for use in a clinical trial, to: (1) issue a notice of application no later than 90 days after receipt of an application and all necessary information to issue such notice; and (2) register an applicant, or serve upon the applicant an order to show cause why registration should not be denied, revoked, or suspended, within 180 days following the close of the comment period and receipt of all information necessary to make a determination.

Source: US House Energy and Commerce Committee and H.R. 639


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