The Enhancement Act amends the Controlled Substances Act by requiring all regulated retail sellers of certain types of scheduled listed chemical products (“SLCPs”) such as pseudoephedrine, ephedrine and phenylpropanolamine (precursor chemicals that can be used for illicit production of methamphetamine) to submit to the Attorney General an additional self-certification prior to selling at retail any SLCP. This “enhanced” certification requires the regulated retailer to self-certify that it understands and agrees to comply with the statutory requirements set forth in 21 U.S.C § 830(d). These statutory requirements include the following: (1) the retailer must adhere to specific daily purchaser limits on retail sales (i.e., a regulated retailer may not sell to any purchaser amounts that exceed a daily amount of 3.6 grams of ephedrine, pseudoephedrine or phenylpropanolamine) regardless of the number of transactions; (2) the retailer may not sell the non-liquid form of the product unless the product is packaged in a blister pack; and, (3) the retailer must submit regular reports of sales activity to the government.

Pharma and Medical Device LitigationOn July 24, 2023, a new final rule from the Drug Enforcement Administration (DEA) became effective, with important consequences for companies and individuals registered to manufacture, distribute, or dispense controlled substances. Specifically, DEA will now require that registrants submit DEA’s “Form 106”, which provides information regarding the theft or significant losses of controlled substances, electronically and within 45 calendar days of discovery of the theft or loss. As there previously was no specific deadline to submit Form 106, this update could have significant potential implications for companies at all levels of the controlled substances supply chain and require immediate attention and allocation of resources to ensure compliance.Pursuant to the relevant provision of the Controlled Substances Act (CSA), 21 U.S.C. § 830(b)(1)(C), all individuals and entities registered to manufacture, distribute, or dispense controlled substances must report “any unusual or excessive loss or disappearance of a listed chemical under the control of the regulated person.” DEA regulations have provided additional guidance on this requirement, previously requiring in 21 C.F.R. § 1301.74(c) that:The registrant must notify the Field Division Office of the Administration in his or her area, in writing, of any theft or significant loss of any controlled substances within one business day of discovery of the theft or loss. . . . The registrant must also complete, and submit to the Field Division Office in his or her area, DEA Form 106 regarding the theft or loss. Thefts and significant losses must be reported whether or not the controlled substances are subsequently recovered or the responsible parties are identified and action taken against them.Similarly, 21 C.F.R. § 1301.76(b) previously provided:The registrant shall notify the Fiel

Brokers and traders must also electronically file notifications for international transactions involving listed chemicals that meet or exceed the thresholds not later than 15 calendar days before the transaction is to occur.The final rule also mandates electronic submission of required monthly reports of domestic transactions involving ephedrine, pseudoephedrine, phenylpropanolamine, and gamma-hydroxybutyric acid (including drug products containing these chemicals/controlled substances) through the U.S. Postal Service or any private or commercial carrier required to be filed pursuant to 21 U.S.C. 830(b)(3). DEA is implementing a new DEA Form 453 to be completed and submitted through the DEA Diversion Control Division secure network application.

20,520. In addition, it is unlawful for mail-order distributors to “negligently fail to self-certify” under 21 U.S.C. § 830 (by an amendment to 21 U.S.C. § 842(a)(10)).The interim rule is effective April 13, 2011. Note, however, that the law requiring self-certification became effective on April 10, 2011 (180 days after its enactment on October 10, 2010).