Topic
Drug Compounding
46 published works
Whistleblower Law Collaborative Blog and News
John Oliver’s Dim View of Compounding Pharmacies
In a recent episode of Last Week Tonight, John Oliver explained drug compounding pharmacies and highlighted some of the problems they pose for regulators and the public. [embedded content] Drug…
Life Sciences Legal Update
FDA Partners with the National Association of Boards of Pharmacy to Create an Information-Sharing System for Drug Compounding Activities
By Rachael G. Pontikes, Emily L. Hussey, Kelly Kearney, Allyson Wilson
On October 2, 2019, the United States Food & Drug Administration (FDA) announced that it awarded a cooperative agreement grant to the National Association of Boards of Pharmacy (NABP) to…
Life Sciences Legal Update
To close out 2018, FDA published a revised draft guidance on human drug compounding for outsourcing facilities
By Rachael G. Pontikes, Kelly Kearney
In accordance with the United States Food & Drug Administration’s (“FDA”) 2018 Compounding Policy Priorities Plan, on December 11, 2018, FDA published its revised draft guidance regarding human drug compounding…
Pharmacy & Healthcare Legal Blog
FDA’s new guidelines on bulk-drug compounding
In its recent guidance “Evaluation of Bulk Drug Substances Nominated for Use in Compounding” for outsourcing facilities, FDA again prioritized the use of FDA-approved drugs over more risky, custom-made medicines produced…
Health Law Diagnosis
FDA’s New Draft Guidance on Bulk Drug Substances in Compounding
By Robinson+Cole's Health Law Group
This week, the U.S. Food & Drug Administration (FDA) published draft guidance, describing FDA’s policy and process for evaluating bulk drug substances used in compounding by outsourcing facilities that are…
Health Law Diagnosis
FDA Issues New Compounding Guidance
By Robinson+Cole's Health Law Group
In January 2018, the U.S. Food & Drug Administration (FDA) published two guidance documents on Compounded Drug Products That Are Essentially Copies Of Approved Drug Products under Section 503A and…
Animal Law Update
Why pet owners are understandably confused about pet medications.
FDA’s recent announcement that it is “withdrawing draft Guidance for Industry (GFI) #230, ‘Compounding Animal Drugs from Bulk Drug Substances’” reminded me that pet owners can become confused about what type…
Life Sciences Legal Update
FDA Withdraws “Compounding Animal Drugs from Bulk Drug Substances” Draft Guidance
By Rachael G. Pontikes, Emily L. Hussey, John D. Kendzior
The U.S. Food & Drug Administration (“FDA”) announced on November 7, 2017, that it is withdrawing the draft Guidance for Industry #230, “Compounding Animal Drugs from Bulk Drug Substances.” FDA…
Health Industry Washington Watch
Recently Released Enhanced Regulatory Initiatives for Drug Compounders
By Rachael G. Pontikes, Emily L. Hussey, John D. Kendzior
On September 26, 2017, FDA Commissioner Scott Gottlieb, M.D. released a statement about FDA’s ramped up regulatory initiatives for drug compounders. These initiatives include: (1) publishing a report that provides…
Life Sciences Legal Update
The FDA Releases Enhanced Regulatory Initiatives for Drug Compounders
By Rachael G. Pontikes, Emily L. Hussey, John D. Kendzior
On September 26, 2017, FDA Commissioner Scott Gottlieb, M.D. released a statement about FDA’s ramped up regulatory initiatives for drug compounders. These initiatives include: (1) publishing a report that provides…