New Law Provides More Certainty on When Controlled Substances are Officially Approved

December 15, 2015

President Obama recently signed the Improving Regulatory Transparency for New Medical Therapies Act into law. The law clarifies when controlled substances are officially approved by the FDA, assisting with the calculation of exclusivity and patent terms. In addition, the law also establishes a new deadline for the DEA to schedule these substances, after they are approved by the FDA.

What is a controlled substance?

A controlled substance is defined as "a drug which has been declared by federal or state law to be illegal for sale or use, but may be dispensed under a physician’s prescription." The federal government groups these substances into five categories based on "whether they have a currently accepted medical use in treatment in the United States, their relative abuse potential, and likelihood of causing dependence when abused." The five categories are called "schedules" and are broken down as follows:

  • Schedule I: "Substances in this schedule have no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse."
  • Schedule II: "Substances in this schedule have a high potential for abuse which may lead to severe psychological or physical dependence."
  • Schedule III: Substances in this schedule have a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence."
  • Schedule IV: "Substances in this schedule have a low potential for abuse relative to substances in Schedule III."
  • Schedule V: "Substances in this schedule have a low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics."

Regulation of Controlled Substances

In 1970 the Controlled Substance Act (CSA) was enacted, establishing a policy the regulation of certain narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and a number of other chemicals. The CSA is implemented by the DEA, and is subject to change by the request of the FDA, HHS, DEA, or another party by submitting a petition to the DEA.

What is the Improving Regulatory Transparency for New Medical Therapies Act?

The new law states that if a drug has never been marketed in the US, the DEA has 90 days to schedule the drug after FDA approval has been granted. If the application is defective, the DEA is required to inform the applicant within ten days by providing a statement explaining why the application is not being accepted. In addition, the law states that the exclusivity period for controlled substances begins the day that the product is scheduled by DEA.

For more information on what the new law includes, view the full document here.

Are you in the process of developing or obtaining FDA-approval for a controlled substance? We can help. We have established a solid track record of helping our clients achieve successful outcomes with FDA. For more information on our regulatory affairs services or to learn how we can help you, please contact us.


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