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Pharmaceutical Industry Reporting Requirements New Regulations

Quarles & Brady LLP

Alabama Board of Pharmacy Issues Non-Disciplinary Fine Schedule

Quarles & Brady LLP on

On August 20, 2025, the Alabama Board of Pharmacy (the “Board”) issued its long-awaited non-disciplinary penalty schedule via emergency rulemaking. The rule went into effect immediately and will expire on December 18, 2025....more

DLA Piper

FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for...

DLA Piper on

The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting requirements for a nonprescription drug product with an “additional condition for...more

Smart & Biggar

New PMPRB regulations registered, in force July 1, 2022, interim approach to pricing announced

Smart & Biggar on

As previously announced, the amended Patented Medicines Regulations will be coming into force on July 1, 2022 in substantially revised form. As we previously reported, the new basket of countries for Patented Medicine Prices...more

Smart & Biggar

PMPRB update: New regulations now coming into force July 1, 2022

Smart & Biggar on

The coming into force date of the amended Patented Medicines Regulations governing the Patented Medicine Prices Review Board (PMPRB) has been deferred for the fourth time, now until July 1, 2022. The news was announced on...more

Smart & Biggar

PMPRB proposes to modify Guidelines definition of "gap medicine" to include medicines sold by July 1, 2021

Smart & Biggar on

Update: See our March 30, 2021 article, which reports the outcome of the consultation, and our April 29, 2021 article reporting an update to compliance timelines for Grandfathered and Gap medicines. Further updates, including...more

Smart & Biggar

Amendments to PMPRB Regulations will now be in force July 1, 2021

Smart & Biggar on

Update: See our January 26, 2021 article, which links to the Canada Gazette copy of the further amendments and discusses proposed consequential modifications to the Guidelines definition of “gap medicine” and compliance...more

Troutman Pepper Locke

Pharmaceutical Waste Rule to Impose New Reporting Requirements on Health Care Facilities

Troutman Pepper Locke on

A new rule proposed by the EPA to take effect in July 2018 would redefine pharmaceutical waste under the Resource Conservation and Recovery Act (RCRA), fundamentally altering how the pharmaceutical supply chain currently...more

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