Under the federal Controlled Substances Act (CSA) and the Drug Enforcement Administration’s (DEA) implementing regulations, pharmacies must deliver controlled substances to the ultimate user. Common sense, as well as DEA’s...more
As of January 1, 2025, parties to transactions involving pharmacies located in California may also need to file a written notice with the California Attorney General. Assembly Bill 853 (AB 853), codified at Part 14 to...more
10/1/2024
/ Acquisitions ,
Corporations Code ,
Federal Trade Commission (FTC) ,
Filing Requirements ,
Hart-Scott-Rodino Act ,
Internet Retailers ,
Mergers ,
NAICS ,
Notice Requirements ,
Pharmaceutical Industry ,
Pharmacies ,
Retailers ,
State Attorneys General
On June 27, 2023 the FDA published Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry. In this draft guidance, FDA provides examples of activities prohibited...more
6/29/2023
/ Comment Period ,
Draft Guidance ,
Drug Compounding ,
Food and Drug Administration (FDA) ,
Hospitals ,
Outsourcing ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Supply Chain ,
Wholesale
Key Takeaways:
..FDA created a new category for voluntary firm registration after NECC compounding fungal meningitis outbreak in 2012.
..Individuals face criminal liability for misrepresentations made to FDA....more
The U.S. Court of Appeals for the Third Circuit is currently hearing arguments from pharmaceutical manufacturers Novo Nordisk, Sanofi and AstraZeneca and the Department of Health and Human Services (HHS) on whether the 340B...more
11/22/2022
/ AstraZeneca ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Medicare ,
Novo Nordisk ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Sanofi ,
Section 340B
On Dec.30, 2020, the Department of Health and Human Services (HHS) Office of the General Counsel released an advisory opinion concluding that drug manufacturers are obligated to deliver discounts under the 340B Drug Pricing...more
On Dec. 10, the United States Supreme Court issued its ruling in Rutledge v. Pharmaceutical Care Management Association. The Court reversed the 8th Circuit to uphold a state’s ability to regulate the price at which pharmacy...more
12/14/2020
/ Drug Pricing ,
Employee Retirement Income Security Act (ERISA) ,
Health Insurance ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Preemption ,
Prescription Drug Coverage ,
Prescription Drugs ,
Rutledge v Pharmaceutical Care Management Association ,
SCOTUS
Food - FDA Released Retail Food Employee Health Handbook – The FDA published the Employee Health and Personal Hygiene Handbook to help food employees avoid spreading viruses and bacteria to food....more
11/2/2020
/ Biosimilars ,
Coronavirus/COVID-19 ,
Employee Handbooks ,
Food and Drug Administration (FDA) ,
Food Safety ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacist ,
Product Labels ,
Supply Chain ,
Vaccinations
Efforts to increase testing are occurring at the national and state levels. The Food and Drug Administration (FDA) continues to crack down on firms marketing products – including drugs, testing kits and personal protective...more
With this update, we have covered and provided Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and state boards of pharmacy actions related to COVID-19 for more than one month. This update will...more
Food - Investigations Are Ongoing Into Recalled Mushrooms – FDA, CDC, and state and local partners are currently investigating a multistate outbreak of Listeria monocytogenes infections linked to enoki mushrooms. FDA...more
Multiple regulatory agencies continue to do their part in the fight against COVID-19. This week, the U.S. Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA) and state boards of pharmacy all acted to...more
Cosmetics - FDA Requested Comments on Information Collection for Cosmetics – FDA announced it is seeking comment on information collection activities regarding FDA’s cosmetic labeling regulations and its Voluntary Cosmetic...more
Shortages of gloves, gowns, face masks, respirators, ventilators, drugs and hand sanitizer continue to be reported. The crackdowns on prescribing of chloroquine and hydroxychloroquine, currently being studied to treat...more
The U.S. now has the most confirmed coronavirus cases in the world, and the FDA and state boards of pharmacy are issuing daily guidance on how to stop the spread or join in the fight through relaxed standards or expedited...more
3/30/2020
/ Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Safety ,
Manufacturers ,
Medical Devices ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Pharmacies ,
Restaurant Industry ,
Veterinarians
Hand sanitizer, critical infrastructure, drug shortages and Emergency Use Authorizations (EUAs) are the FDA updates on COVID-19 over the weekend....more
The Food and Drug Administration (FDA) and the state boards of pharmacy continue to issue guidance and policy daily. Now, the Drug Enforcement Administration (DEA) has joined in to provide guidance to industry and healthcare...more
The new coronavirus continues to be the leading global news headline. We have established a comprehensive online resource center to help address and answer legal questions about coronavirus disease 2019 (COVID-19). ...more