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The Wholesaling Prohibition (Potentially) Demystified? FDA’s Take on Supply Chains for Section 503B Outsourcing Facilities

FDA Law Blog

Palmer — Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance).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)(8). Section II at 2. the wholesale distributor, repackager, relabeler).

Drugs 52
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Medical Science Liaison Jobs: Everything You Need to Know

XTalks

Some may even extend their expertise to consumer goods sectors, including cosmetic brands. Calibrating drug strength, methodologies and dosages to facilitate large-scale manufacturing and distribution of pharmaceuticals and medicinal compounds. Innovating and evaluating medical equipment. What Is the Job Outlook Like?

Doctors 59
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FDA Flexibilities, Collaboration to Yield Millions of Bottles of Specialized Medical Infant Formula in Coming Months to Increase U.S. Supply

The Pharma Data

Food and Drug Administration is providing an update on steps it has taken that will lead to millions of bottles of specialized medical infant formula to help address immediate needs for infants with certain allergies or critical health conditions. Today, the U.S. We continue to work closely with our U.S. as quickly as possible.

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Is 2023 the Year for OTC Naloxone?

FDA Law Blog

Richardson — On February 15, 2023, the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) held a joint meeting to discuss an application pending before FDA that would switch Narcan (naloxone) Nasal Spray from prescription to over-the-counter (OTC) status.

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Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “generic” drugs of the biopharma world. What is a Biosimilar?

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FDA opens door to expressly permit personal drug importation, and yet…

Pharmacy Checkers

In most cases, the reason is that the same drugs sold in the U.S. million Americans import drugs to save money each year. First, wholesale importation of lower cost drugs from Canada is now lawful. That is pursuant to Section 804 of the Food, Drug and Cosmetic Act. are much cheaper elsewhere.

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Black History Month: Recognizing the Revolutionary Contributions of Black Individuals in Science

XTalks

Ball went on to study chemistry at the University of Washington, earning a bachelor’s degree in pharmaceutical chemistry, followed by a second degree in pharmacy two years later. Since then, the cells have been used to test sensitivity to various products ranging from glue to cosmetics.