On Jan. 5, the FDA authorized Florida’s Section 804 Implementation program (SIP), making Florida the first state to secure such approval.
Generally, there are three pathways to importing a prescription drug into the United...more
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27, 2023 the FDA published Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry. In this draft guidance, FDA provides examples of activities prohibited...more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Draft Guidance ,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
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
FDA Released Food Traceability Proposed Rule – The United States Food and Drug Administration (FDA) is proposing to establish additional traceability recordkeeping requirements for manufacturers, processors, packers or...more
10/9/2020
/ DEA ,
Food and Drug Administration (FDA) ,
Food Safety ,
Imports ,
Medical Devices ,
Pharmaceutical Industry ,
Product Labels ,
Recordkeeping Requirements ,
Seafood ,
Supply Chain ,
Tobacco ,
USDA
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
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