Compounding

Lachman Consultant Services, Inc. / Blog / Compounding
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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20
Apr

All Hands-On Deck – Pharmacy Compounding for Hospitals of Certain Drugs Approved in a Pinch

By    Apr 20, 2020    Compounding COVID-19 FDA Regulatory Affairs

Early on Monday morning April 20, 2020, the FDA announced a relaxed policy for pharmacy compounders, if there is a shortage of certain drug products to treat COVID-19 patients that are not available through the normal supply chain or from a registered outsourcing facility. The guidance, titled Temporary Policy for Compounding of Certain Drugs for […]

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20
Apr
Capsules in mortar

Emergency Preparedness – FDA Continues Active Oversight in the Compounding Space

By    Apr 20, 2020    Compliance Compounding Device FDA Regulatory Affairs

FDA has been discussing using temporary enforcement discretion in two April 2020 Guidance for Industry documents for sterile compounding during the Covid-19 crisis: “Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency (here)” and “Temporary Policy Regarding Non Standard PPE Practices for Sterile Compounding by […]

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10
Apr

Agency Provides Guidance on Mask Shortage in Sterile Compounding Pharmacies

By    Apr 10, 2020    Compliance Compounding FDA Regulatory Affairs

If you are not registered as an outsourcing compounder but are a pharmacy/hospital-based compounder of sterile products, FDA has provided advice for you if the garb that you need (including masks and gloves) are in short supply.  The document does not detail outlining the steps that such compounders can take help assure the sterility and […]

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08
Apr
flying money

Out of Sight – Out of Mind – Not Hardly and No Refunds

By    Apr 08, 2020    Compliance Compounding Facilities Outsourcing Regulatory Affairs

FDA issues Guidance for Industry: “Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act, April 2020”. With all that’s going on with Covid-19, FDA is diligently executing their priorities for this fiscal year.  In FY19, FDA’s priorities for Compounding (human drugs) were to: maintain quality manufacturing and compliance; […]

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31
Mar
Caution Tape

FDA Promotes Hydroxychloroquine to Category 1 Status for Compounders – Wait a Minute!

By    Mar 31, 2020    Compliance Compounding FDA Regulatory Affairs

My eyes almost popped out of my head when I read this article (here) concerning FDA’s move to place hydroxychloroquine in Category 1 for use by compounders based on a potential drug shortage created mostly by the administration’s hope that the drug may have some effect on COVID 19.  It is one thing to use […]

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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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19
Nov
Vet Drugs Image

CVM Issues Guidance on Enforcement Policy Regarding the Compounding of Vet Drugs Using Bulk Drug Substances

By    Nov 19, 2019    Compliance Compounding CVM Regulatory Affairs

In a guidance posted today, the Center for Veterinary Medicine (CVM) discusses its enforcement discretion policy for the use of bulk substances in the compounding of drugs used for non-food-producing animals and, to a more limited extent, for food-producing animals. Unlike the statute and regulations for human drugs, there are no provisions for compounding animal […]

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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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