02/25/2019

Vilvet Pharmaceutical

Center for Drug Evaluation and Research

CGMP/Finished Pharmaceuticals/Adulterated

Not Issued *

02/26/2019

CanaRx Services Inc

Center for Drug Evaluation and Research

Unapproved New Drugs/Misbranded

Not Issued *

02/28/2019

Andapharm, LLC

Dallas District Office

CGMP/Finished Pharmaceuticals/Adulterated

Not Issued *

FDA will not include vasopressin on 503B bulks list

The Pharma Letter-14 hours ago

As a result, it will be unlawful for outsourcing facilities to sell compoundedvasopressin products unless they manufacture those products using an FDA-approved ..

San Antonio Area Drug Company Sales Rep Pleads Guilty in $8M ...

Insurance Journal-7 hours ago

In many instances, Blakely and her co-conspirators submitted prescriptions to compoundingpharmacies for patients that had never seen a medical professional.

Health Industry Alert: FDA Finalizes Criteria, and First Two Exclusions ...

https://www.akingump.com/.../fda-issues-its-first-decisions-on-outsourcing-facility.ht...

2 hours ago - As a result, drug products compounded by outsourcing facilities that contain ... (FDA) finalized two long-awaited policies relating to the compounding of bulk drug ...

MedPage Today: Vaccine Battles Rage

https://www.medpagetoday.com/infectiousdisease/vaccines/78335?xid=nl_mpt_morningbreak2019-03-04&eun=g649657d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=MorningBreak_030419&utm_term=NL_Daily_Morn_Break_Active

FDA provides update on its ongoing investigation into ARB drug products; reports on finding of a new nitrosamine

The U.S. Food and Drug Administration is updating the public on the agency’s ongoing investigation surrounding the recent voluntary recalls of multiple generic angiotensin II receptor blocker (ARB) drug products used to treat high blood pressure and heart failure. Hetero Labs Ltd. in India has announced a recall of 87 lots of losartan potassium tablets (25 mg, 50 mg and 100 mg). The recalled losartan potassium tablets made by Hetero Labs and distributed by Camber Pharmaceuticals contain the impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The impurity is a known animal and potential human carcinogen. This is the first ARB recall resulting from...

Dr. Reddy's solid dose plant pinched by FDA for missteps

Wednesday, February 27, 2019

The FDA keeps rolling through the Indian manufacturing plants of Dr. Reddy’s Laboratories, and the Form 483s keep falling out.

FDA In Brief: FDA finalizes guidance on evaluating the clinical need for outsourcing facilities to compound drugs with bulk drug substances; provides final decision on two substances

Today, the U.S. Food and Drug Administration issued a final guidance for industry, Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act. This guidance addresses the FDA’s policies for developing a list of bulk drug substances that can be used in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), also known as the 503B bulks list, including the agency’s interpretation of “bulk drug substance for which there is a clinical need,” which is the statutory standard for compounding from bulk drug substances. The guidance also highlights criteria the agency generally intends to use to ...