Department of Health and Human Services May 10, 2023 – Federal Register Recent Federal Regulation Documents

On March 1, 2023 the Drug Enforcement Administration (DEA), in concert with the Department of Health and Human Services (HHS), promulgated two notices of proposed rulemakings (NPRMs) soliciting comments on proposals to allow for prescribing of controlled medications pursuant to the practice of telemedicine in instances where the prescribing practitioner has never conducted an in-person medical evaluation of the patient. Those NPRMs resulted in 38,369 public comments, which are being closely reviewed. DEA, in concert with HHS, is considering revisions to the proposed rules set forth in the NPRMs. In the meantime, and following initial review of the comments received, DEA, jointly with the Substance Abuse and Mental Health Services Administration (SAMHSA), is issuing this temporary rule to extend certain exceptions granted to existing DEA regulations in March 2020 as a result of the COVID-19 Public Health Emergency (COVID-19 PHE), in order to avoid lapses in care for patients. Ultimately, there will be a final set of regulations permitting the practice of telemedicine under circumstances that are consistent with public health, safety, and effective controls against diversion.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Detectnet and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled ``Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol.'' This guidance provides updated recommendations on testing and other activities that will help pharmaceutical manufacturers, repackers, other suppliers, and compounders prevent the use of high-risk drug components, including glycerin, propylene glycol, maltitol solution, hydrogenated starch hydrolysate, and sorbitol solution, that are contaminated with diethylene glycol (DEG) and ethylene glycol (EG). These and other appropriate measures under current good manufacturing practice (CGMP) are vital to prevent incidents of consumer poisoning.