Compounders

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08
Jul

Just When you Thought it Was Safe to Come out of the Compounding Hood: Apparent Dearth of Evidence for the Effectiveness & Safety of Compounded Bioidentical Hormone Therapy

By    Jul 08, 2020    Compliance Compounders Compounding Efficacy Safety

In late 2018, FDA entered a contract with the National Academies of Sciences, Engineering, and Medicine (the National Academies) to examine the clinical utility (effectiveness), safety and uses of compounded bioidentical hormone therapy (cBHT).  A high-level committee was formed and examined in detail the clinical utility of cBHT drug preparations, especially those containing estradiol, estrone, […]

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17
Mar

Hand Sanitizer Relief – A Compounders’ Guide to A Safe and  Effective Product

By    Mar 17, 2020    Compounders FDA Regulatory Affairs

In response to the COVID-19 pandemic, FDA released guidance on March 14, 2020 allowing state licensed pharmacies, compounders, and certain federal facilities (referred to collectively as compounders) to manufacture hand sanitizers. In this guidance, FDA indicated that they are aware of people making their own sanitizers due to the shortage of sanitizers on the market, […]

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26
Nov
Thanksgiving Image

Hope at This Time of Giving Thanks

By    Nov 26, 2019    505(b)(2) Abuse deterrent Accelerated Approval Advertising Analytical Methods ANDAs Approvals Bioanalytical Bioequivalence Biologics Biosimilars BLA Brand Name Drugs Bulk Drugs List CBER CDER Chemistry Clinical CMC Combination Products Complex Generics Compliance Compounders Compounding Controlled correspondence CVM Data Integrity DEA Device Dietary Supplements Drug Pricing Drug Shortages eCTD Emerging Technology Enforcement Exclusivity FDA FDA First Generics Foods GDUFA Fees Generics Guidance Homeopathic Drugs ICH Imports International Label Changes Labeling Laboratories Manufacturing Medical Devices NDA New Drugs OGD Opioids OTC Petitions PMA Post Approval projectsnowflake Receipts Regulatory Affairs Safety Science & Technology Shortages Training Uncategorized User Fees Validation

Just look around, watch the television, read the newspaper, and what do you see?  Seems like very few reasons to be thankful.  School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth.  Climate change is threatening the future of our children, and the environmental controls […]

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01
Oct

Vasopressin Verdict May be Precedent for Drug Companies Seeking to Protect Approved Products

By    Oct 01, 2019    Compounders Compounding FDA NDA Regulatory Affairs

In his article “Endo comes out on top in its fight with FDA and bulk compounder” published in Fierce Pharma (here), Eric Palmer has pointed to a potentially precedent-setting decision that may have further implications for the outsourcing compounding community.  The FDA has a long-standing policy regarding the marketing of unapproved drugs after the first […]

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12
Jun

Could the Compounding Responsibility Move to CDER’s Office of Compliance Signal Increased Enforcement Priorities?

By    Jun 12, 2019    Compounders Compounding FDA

We love reading other regulatory pieces, and particularly liked the one written by Regulatory Focus’ Michael Mezher (here) concerning the “agency plans to “institutionalize” its compounding regulatory program within the center’s Office of Compliance.”  While this may provide a better focus for the FDA to coordinate efforts through CDER resources, it could also mean a […]

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