Verisys

DECEMBER 12, 2023

Compliance Updates: December 2023 Overlook: Federal Legislation DEA Licensure Compacts Other Legislation Board Updates Federal Legislation: The TREATS Act has been proposed which would amend the Controlled Substances Act to allow for the use of telehealth in substance use disorder treatment. Collaborative Practice ( 680-X-2-.44

Regulatory Compliance 52

Regulatory Compliance Compliance US Department of Health and Human Services Licensing 52

SQA

FEBRUARY 15, 2023

Relevant matters are hereby announced as follows: As of 01 December 2022, the Electronic Certificates of Documentation for Export of APIs to the EU and Certificate of a Pharmaceutical Product will be put into use. Efforts should be made to promote and guide the use of electronic certificates.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

Hall Render

APRIL 14, 2023

NATIONAL 94% of Organizations Experienced a Cyberattack in 2022 AHA blog: Strengthening crisis management in rural health care Biden signs bill ending Covid-19 national emergency Cancer drug shortages are creating dire circumstances for some patients CMS Releases FY24 IPPS Proposed Rule, Seeks to Boost Rates by 2.8%

Nursing Homes 40

Nursing Homes US Department of Health and Human Services Nurses COVID-19 40

SQA

OCTOBER 18, 2022

Health Canada. Health Canada is warning consumers about counterfeit BTNX Rapid Response COVID-19 antigen rapid test kits (25-pack boxes) found in Ontario. The counterfeit devices were sold online by a distributor named Healthful Plus without the required license to import, distribute, or sell medical devices in Canada.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 Compliance 40

Drug & Device Law

DECEMBER 29, 2023

In 2023 there seemed to be an unusually large number of other decisions that are likely to have a substantial impact on what we or our clients do, but involve either different products, non-product claims, or both. In 2023, these include United States ex rel. Executive Health Resources, Inc. , Another year bites the dust.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105