HIPAA Minimum Necessary Standard Should Be Key Component of Policies and...
On January 17, 2013, the U.S. Department of Health and Human Services ("HHS") announced the final omnibus rule amending the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") in...
View ArticleCMS Publishes Physician Payment Sunshine Rules; Manufacturers and Group...
On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited rules (the "Rules") detailing manufacturers' and group purchasing organizations' reporting...
View ArticleResearch-Related Payments and the Physician Payment Sunshine Act: How...
On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) published long-awaited rules (the "Rules") detailing manufacturers' and group purchasing organizations' reporting...
View ArticleFDA Emphasizes Patient-Specific Prescriptions
On March 7, 2013, the United States Food and Drug Administration (FDA) issued a warning letter to compounding pharmacy Medi-Fare Drug & Home Health Center (Medi-Fare Drug), taking the FDA's most...
View ArticleCongress Drafts Compounding Legislation -- Defines Compounded Drugs as "New...
In the wake of the New England Compounding Center meningitis outbreak, the federal government has actively pushed for greater legislative oversight over compounding pharmacies. On April 26, 2013, the...
View ArticleFDA Issues Guidance Detailing Specific Requirements for Quality Agreements...
On May 28, 2013, the U.S. Food and Drug Administration (FDA) published a draft guidance ("the Guidance") detailing the FDA's current thinking on contract manufacturing arrangements for drugs....
View ArticleFDA Issues Proposed Rules That Give FDA Administrative Detention Authority...
On July 15, 2013, the U.S. Food and Drug Administration (FDA) released proposed rules implementing sections of the Food and Drug Administration Safety and Innovation Act (FDASIA) and the FDA's new...
View ArticleCompounding Legislation Goes Through Another Change: New House Bill on...
U.S. Rep Griffith Releases Revised Draft Bill Providing Federal Oversight over Compounding Pharmacies - On July 11, 2013, U.S. Representative Morgan Griffith (R-Va.) released a revised draft House Bill...
View ArticleGovernmental Agencies and Regulatory Boards Must Now Provide a Reasoned...
The days of governmental agencies or regulatory boards issuing decisions without providing any reasoning may be nearing an end. The Illinois Appellate Court for the Fourth District recently clarified...
View ArticleSenate HELP Committee Releases Revised Senate Bill Providing Federal...
Compounding Legislation Continues to See More Changes - The Senate HELP Committee has released a revised draft Senate Bill ("Revised Senate Bill"), updating the committee's first proposed compounding...
View ArticleCompounding Pharmacies Now Subject to Federal Oversight
On November 27, 2013, President Obama signed into law the Drug Quality and Security Act. Title I of this law—entitled the Compounding Quality Act (the "CQA")—allows the federal Food and Drug...
View ArticleFDA Releases Draft Guidance on Section 503B Fees for Drug Compounding...
On April 1, 2014, the U.S. Food and Drug Administration (FDA) published notice of its Draft Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug,...
View ArticleFDA Gives Guidance on Compounding for Human Use
In July 2014, the U.S. Food and Drug Administration (FDA) released five documents containing policies and proposals that affect both traditional compounding pharmacies and outsourcing facilities that...
View ArticleDEA Releases Final Rule on Disposal of Controlled Substances
On September 9, 2014, the U.S. Drug Enforcement Administration (DEA) released notice of a final rule governing the disposal of controlled substances (the "Final Rule"). The Final Rule implements the...
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