FDA Law Blog: Biosimilars

FEBRUARY 2, 2025

The rules were implemented to enhance patient safety protections via revised drug handling, packaging, and delivery requirements. The rules include changes to the notification process, medication packaging, the handling of reports, and safety issues. The most common drug Californians may be looking for this winter is Paxlovid.

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Packaging Documentation Compounding 59

European Pharmaceutical Review

NOVEMBER 24, 2022

One area in which the problem can be tackled effectively is product packaging. With predictions that the global market for anticounterfeiting packaging is set to reach almost $250 billion by 2026, growth in authentication and anti-tamper devices such as holograms appear to have a healthy future.”

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Packaging Labelling Documentation Dosage 111

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

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Labelling Packaging Documentation 59

National Association of Boards of Pharmacy

OCTOBER 23, 2024

The exemption applies to “any … eligible trading partners, which … have successfully completed or made documented efforts to complete data connections with their immediate trading partners.” FDA took the right approach balancing the advancement of DSCSA implementation with risk of potential impacts to the flow of medicine.

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Packaging Documentation Pharmacy Technician 49

National Association of Boards of Pharmacy

JULY 19, 2024

On June 12, 2024, Food and Drug Administration (FDA) issued exemptions for certain dispensers and in limited scenarios, their trading partners, from certain requirements of section 582 under the Food Drug and Cosmetic Act (FD&C Act) until November 27, 2026. Gathering transaction information for recalls at the package level.

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Pharmacy Technician Documentation Communication Packaging 45