XTalks

JUNE 5, 2023

During a drug shortage, compounders might be allowed to prepare a compounded version of the drug provided they meet specific requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act. mg and 1 mg doses will be available to wholesalers for distribution to retail pharmacies. mg and 2.4 mg doses of Wegovy.

FDA Approval 98

FDA Approval Containment Drugs Pharmacy 98

Pharmacy Checkers

FEBRUARY 12, 2021

The bill not only calls for wholesale importation from Canada – but also personal drug importation from Canada and other countries, subject to Section 804 of the Food, Drug, and Cosmetic Act. The channel of importation is confined to a wholesaler in Canada exporting FDA-approved drugs to a state-licensed wholesaler in the United States.

Drugs 71

Drugs Pharmacy Licensing Licensing 71

FDA Law Blog

JULY 5, 2023

Palmer — Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance). See 21 U.S.C. 353b(a). Section II at 2. Draft Guidance III.B.2(e)

Drugs 52

Drugs Production Manufacturing Licensing 52

Pharmacy Checkers

OCTOBER 2, 2020

Department of Health and Human Services and Food and Drug Administration (HHS/FDA), the door has been opened to formally allow personal drug importation, but the proposed parameters of the RFP ignore greater opportunities, savings and the law itself. That is pursuant to Section 804 of the Food, Drug and Cosmetic Act.

Pharmacy 54

Pharmacy Drugs FDA Approval Cosmetics 54

Pharmacy Checkers

JANUARY 4, 2020

The FDA has drafted a proposed rule to facilitate wholesale importation of lower-cost drugs from Canada, pursuant to Section 804 of the Food, Drug and Cosmetic Act. J(2) stipulates that the FDA can permit personal imports with specific waivers or by general regulation. Those pharmacies aren’t rogue. That is a problem.

Drugs 58

Drugs Pharmacy Medicine Regulation 58

Pharmacy Checkers

AUGUST 2, 2019

The reality is that Americans have already been importing medications from foreign pharmacies because of substantially lower prices for many years, and the law is currently flexible to allow them to do so. The first proposed channel of prescription drug importation is already codified in law: Section 804 of the Food, Drug and Cosmetic Act.

Drugs 69

Drugs FDA Approval Pharmacy Cosmetics 69

Pharmacy Checkers

MARCH 11, 2020

Founded in 2002, and launching its website in 2003, PharmacyChecker provides consumers with online pharmacy verification and comparative drug price information to help them make the best decisions for themselves and their families on how to afford prescription drugs. counterparts. Part J is written in three sections.

Pharmacy 41

Pharmacy Drugs FDA Approval Licensing 41