The Law of Compounding Medications And Drugs

Thursday, June 28, 2018

United States: Florida Repeals Laboratory Licensure Requirements Effective July 1st

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

The repeal will save laboratories time and money.

United States: Non-Compete Found So Overbroad As To Be Unenforceable And Unfixable

Masuda, Funai, Eifert & Mitchell, Ltd.

Recently, a former employer sought injunctive relief against a former executive whom it claimed had violated his Employee Confidentiality/Non-Compete Agreement ...

Court Rules That Boehringer Doesn’t Have to Give Barr Deal Analysis to the FTC

Posted: 27 Jun 2018 06:42 PM PDT

By Jennifer M. Thomas —

On June 19, the D.C. Circuit issued a decision setting forth the Court’s views on attorney-client privilege in Federal Trade Commission v. Boehringer Ingelheim Pharms., Inc. The D.C. Circuit previously ruled on attorney work-product protection issues in the same matter. See 778 F.3d 142 (D.C. Cir. 2015). Boehringer ultimately prevailed in its attorney-client privilege claims, and the case provides good precedent for companies facing disputes with the government over attorney-client privilege. However, the D.C. Circuit and underlying District Court decisions also highlight the difficulty of establishing privilege over dual-purpose documents and communications.

CMS denies Massachusetts' request to choose which drugs Medicaid covers

The CMS has turned down Massachusetts' request to choose which drugs it will cover for Medicaid patients. Advocates had worried the request, an effort to keep costs down, would block access to innovative and life-saving drugs. READ MORE

Supreme Court ruling on union fees could shift healthcare politics

American political dynamics around healthcare and other issues could be changed by a U.S. Supreme Court decision Wednesdaythat significantly weakens public-sector labor unions. READ MORE

FDA Releases Guidance to Help Animal Drug Sponsors with Antimicrobial Animal Drug Sales and Distribution Reporting Requirements

The U.S. Food and Drug Administration today is releasing Guidance for Industry #252, entitled “Antimicrobial Animal Drug Sales and Distribution Reporting Small Entity Compliance Guide.” This small entity compliance guide (SECG) is intended to help small businesses comply with the Antimicrobial Animal Drug Sales and Distribution final rule.

Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105) requires antimicrobial animal drug sponsors to annually report to the FDA the amount of all antimicrobial drugs they sell and distribute for use in food-producing animals, including those medically important antimicrobials that are used in human and veterinary medicine.

The FDA published a final rule in May 2016 to incorporate the annual reporting requirements for sponsors of antimicrobial drugs sold or distributed for use in food-producing animals that were established by ADUFA 105 into its existing records and reports regulations in 21 CFR part 514 and also added an additional reporting provision in order to obtain estimates of sales broken out by major food-producing species (i.e., cattle, swine, chickens, turkeys).

The additional data collected as a result of this rulemaking and supporting guidance issued today will improve our understanding of how antimicrobial drugs are sold and/or distributed for use in major food-producing species.

Pharmacy benefit manager turns to analytics to fight healthcare fraud

TechTarget-11 hours ago

Billions of dollars are lost to healthcare fraud annually, and one pharmacy benefit manager is fighting back by applying advanced data analytics to a ..

Pharmacy to pay $75K for failing to keep accurate opioid records

fox5sandiego.com-4 hours ago

LAKESIDE, Calif. — A pharmacy in Lakeside and its owners will pay $75,000 to resolve allegations that they failed to properly account for highly addictive and ...

California News: SAN DIEGO, Lakeside Pharmacy Pays $75000 for ...
STL.News (blog)-7 hours ago

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