DEA issues rule on Schedule I positional isomers
The Drug Enforcement Administration (DEA) has issued a final rule that adds the definition of positional isomers to 21 CFR 1300.01 (b) (21). The change will allow for the systematic determination of which isomers of Schedule I substances would be subject to Schedule I control, according to the DEA. The Controlled Substances Act states that all salts, isomers, and salts of isomers of these substances are also Schedule I controlled substances. Specifically, positional isomers are defined as any substance possessing the same molecular formula and core structure and having the same functional group(s) and/or substituent(s) as those found in the respective Schedule I hallucinogen, attached at any position(s) on the core structure, but in such manner that no new chemical functionalities are created and no existing chemical functionalities are destroyed relative to the respective Schedule I hallucinogen. The complete definition can be found at
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.