How is the approval date determined for drug products under the Controlled Substances Act?

For drug products that the Secretary of Health and Human Services intends to recommend controls under the Controlled Substances Act, the approval date is determined differently. According to MPEP 2754.01:

“Where the regulatory review is of a drug product for which the Secretary of Health and Human Services intends to recommend controls under the Controlled Substances Act, the sixty day period of 35 U.S.C. 156(d)(1) begins on the ‘covered date,'”

The “covered date” is defined in 35 U.S.C. 156(i)(2) as the later of:

• The date an application is approved under specific sections of the Public Health Service Act or the Federal Food, Drug, and Cosmetic Act
• The date an application is conditionally approved under section 571(b) of the Federal Food, Drug, and Cosmetic Act
• The date a request for indexing is granted under section 572(d) of the Federal Food, Drug, and Cosmetic Act
• The date of issuance of the interim final rule controlling the drug under section 201(j) of the Controlled Substances Act

This special provision ensures that the patent term extension process accounts for the additional regulatory steps required for controlled substances.

To learn more:

• Controlled Substances Act
• drug approval
• patent term extension
• covered date