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Regulatory Standards Pharmaceutical Industry Pharmacies

Quarles & Brady LLP

Georgia Board of Pharmacy Continues to Review Licensure Requirements for Pharmacists

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At the April 13, 2022 Georgia Board of Pharmacy meeting, the Board discussed changes to Chapter 480-36 which governs retail pharmacy remote drug order processing. The discussion was aimed at new verbiage that would require...more

Quarles & Brady LLP

Kentucky Board of Pharmacy Continues to Research and Review Proposed Non-Resident Pharmacy Permit Regulations

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At the March 30, 2022 Kentucky Board of Pharmacy meeting, the Regulation Committee reported on its March 15 meeting where it discussed the new proposed non-resident pharmacy permit regulation. The Committee requested...more

Quarles & Brady LLP

Texas Board of Pharmacy Sends Central Fill Amendment Back for Redraft but Signals Approval

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On February 1, 2022, the Texas Board of Pharmacy voted to send proposed amendments to its Central Fill Rule under 22 Tex. Admin. Code § 291.125 back to staff for a redraft....more

Quarles & Brady LLP

New Limitations on Chain Pharmacy Quotas in California

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Retail chain pharmacies should be aware of California’s recent passage of SB 362, signed into law by Governor Gavin Newson late last month, and the potential impact of the law on how chains evaluate their pharmacy staff and...more

Epstein Becker & Green

Current Good Manufacturing Practices in the Time of COVID-19: FDA Announces New Expectations on Risk Assessment and Risk...

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FDA recently published its “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing Guidance for Industry” (“Guidance”) which provides...more

Patrick Malone & Associates P.C. | DC Injury...

FDA oversight looks shaky with drug recalls, rising vaping deaths and injuries

Tens of millions of Americans may have been startled in recent days by the much-publicized pulling from the shelves of widely used drugs like ranitidine (aka Zantac), an over-the-counter heartburn remedy, and select lots of...more

Akerman LLP - Health Law Rx

Florida Board of Pharmacy Initiates Work on International Export Pharmacy Permit Application and Rules

International export pharmacies took another step forward towards a separate, distinct licensure in Florida as the Florida Board of Pharmacy held a specially called Rules Sub-Committee Meeting on June 27, 2019, to address the...more

Troutman Pepper

How to Prepare for the FDA's 2019 Enforcement Priorities for the Compounding Industry

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On April 3, FDA Commissioner Scott Gottlieb released a statement outlining the agency’s priorities for 2019 with respect to compounding pharmacies and the compounding industry. ...more

Robinson+Cole Health Law Diagnosis

FDA’s New Draft Guidance on Bulk Drug Substances in Compounding

This week, the U.S. Food & Drug Administration (FDA) published draft guidance, describing FDA’s policy and process for evaluating bulk drug substances used in compounding by outsourcing facilities that are registered under...more

Manatt, Phelps & Phillips, LLP

Will NYSDEC's Audit Agreement for Retail Pharmacies Provide a Path to Increased Compliance?

Federal and state hazardous waste handling and disposal requirements, which were established to address issues related to industrial waste generators and disposal facilities, are often a complicated and awkward fit for retail...more

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