Compliance

23
Jan

FDA 2017 List of 101 Guidances – How Many Apply to Compounding Pharmacies and Are You Current and in Compliance???

For 503A and 503B compounding pharmacies, how do you protect your business from heavy-handed interventions from State and Federal Regulators? Can you affirmatively respond to the following questions? Do you know the Federal and State laws you are required to follow? Do you have the right enabling documentation (procedures, policies, records, etc., in place and […]

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11
Jan

Good News/Not So Good News II? Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities

FDA issued the draft Guidance “Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities” (here) in late December 2016. FDA reminds us that, under current law, radiopharmaceuticals that are compounded by entities that are not registered with FDA as outsourcing facilities (503B), and radiopharmaceuticals that are repackaged are subject to all applicable […]

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10
Jan

Good News/Not So Good News? Compounding and Repackaging of Radiopharmaceuticals

FDA issued two new Guidance for Industry Documents late in 2016: (1) Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities (here) and (2) Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities (here).  These represent the 25th and 26th  draft and/or final Guidances issued by FDA relating to pharmacy compounding.  More will […]

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09
Jan
FDA Starts Push for Transparency in Fulfilling Their 2018 Compounding Policy Priorities Plan Image

FDA Issues Three New Guidances for Compounding Pharmacies on December 28, 2016

FDA issued three new Guidance for Industry Documents late in 2016: (1) Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act (here) ; (2) Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities (here); and (3) Compounding and Repackaging of Radiopharmaceuticals by Outsourcing facilities (here). These represent part […]

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19
Dec

Boxed Warning for Serious Mental Health Issues Removed from Chantix and Zyban Labeling

Back in April 2016, we posted a blog regarding the potential for the FDA to remove the Black Box warning on two products indicated to help patients stop smoking based on a large clinical study that the FDA required.  At that time when the studies were submitted, the Agency indicated it would review the results […]

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15
Dec
FDA Starts Push for Transparency in Fulfilling Their 2018 Compounding Policy Priorities Plan Image

FDA Publishes List of First Bulk Drug Substances for 503A Compounding

The FDA issued a Proposed Rule (here) that announced the first additional 6 bulk drug substances for inclusion on the listing of bulk drug substances acceptable for pharmacy compounding, although they are neither the subject of an applicable United States Pharmacopoeia (USP), nor National Formulary (NF) monograph, nor components of FDA-approved drugs. Specifically, the Agency […]

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05
Dec
Quality Agreements Image

Quality Agreements a “Must Have” for Use of CMO

  The recently issued Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance document (here) states that the FDA considers that the owner’s (those who engage the services of the contract facilities) Quality Unit responsibility includes approving or rejecting the contract facility’s product or service (be it for testing, processing, packing or holding). In addition, as […]

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01
Dec
Happy Holidays – FDA Issues Highly Anticipated Revised Quality Metrics Guidance Image

Happy Holidays – FDA Issues Highly Anticipated Revised Quality Metrics Guidance

On Thanksgiving Eve, FDA issued the revised Quality Metrics Guidance. Is the revised document something for industry to be thankful for? Let’s break it down: Allowance for a phased-in, voluntary approach – This is something that many industry groups have been asking for, since the burden, as well as the complexity of collecting metrics from […]

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