The Drug Supply Chain Security Act (DSCSA) (Title 2 of the Drug Quality and Security Act, P.L. 113-54 (Nov 27, 2013)) amended Chapter V of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding subchapter H —...more
In a stride toward transparency and heightened consumer awareness, the Food and Drug Administration (FDA) has issued a final rule, dated November 21, 2023, to amend its regulations regarding direct-to-consumer (DTC)...more
The state of New Jersey recently passed a law that will allow pharmacists to provide self-administered hormonal contraceptives to patients without a prescription. The law, which was signed by Governor Philip Murphy on January...more
In one year (plus a few days, as of this writing), regulation of the U.S. drug supply chain will be historically changed. On November 27, 2023, the final phase of the Drug Supply Chain Security Act (DSCSA) goes into effect....more
On May 13, 2020, Paul R. Rodríguez, New Jersey’s Acting Director of the Division of Consumer Affairs, issued an Administrative Order permitting licensed pharmacists in New Jersey to order and administer testing for COVID-19....more
On April 15, 2020, the Food and Drug Administration (FDA) updated its three hand sanitizer guidance documents to address the use of fuel- and technical-grade ethanol as an active pharmaceutical ingredient (API) in hand...more
As the 2019 novel coronavirus (COVID-19) is expected to reach its apex in several states over the next two weeks, the Department of Health & Human Services (HHS) has issued new guidance authorizing licensed pharmacists to...more
Food and Drug Administration -
Although some distilleries have tried to pitch in to produce hand sanitizer in the wake of a national shortage caused by the coronavirus public health emergency, hand sanitizers are actually...more