The Drug Supply Chain Security Act (DSCSA) (Title 2 of the Drug Quality and Security Act, P.L. 113-54 (Nov 27, 2013)) amended Chapter V of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding subchapter H —...more
In a stride toward transparency and heightened consumer awareness, the Food and Drug Administration (FDA) has issued a final rule, dated November 21, 2023, to amend its regulations regarding direct-to-consumer (DTC)...more
On May 9th, 2023, the Drug Enforcement Administration (DEA) and Substance Abuse and Mental Health Services Administration (SAMHSA) extended the telemedicine flexibilities that allowed the remote prescribing of controlled...more
The state of New Jersey recently passed a law that will allow pharmacists to provide self-administered hormonal contraceptives to patients without a prescription. The law, which was signed by Governor Philip Murphy on January...more
In one year (plus a few days, as of this writing), regulation of the U.S. drug supply chain will be historically changed. On November 27, 2023, the final phase of the Drug Supply Chain Security Act (DSCSA) goes into effect....more
On November 17, 2021, the Drug Enforcement Administration (DEA) issued an Advanced Notice of Proposed Rulemaking (ANPR) to seek public input from state regulatory authorities, national and professional associations, industry,...more
The Consolidated Appropriations Act, 2021, signed by President Trump on December 27, 2020, included within its over 5,900 pages the controversial and long-debated No Surprises Act (the Act), addressing surprise medical bills....more
On November 20, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued final rules to implement the new exception provided under the Anti-Kickback Statute and the Civil Monetary...more
On May 13, 2020, Paul R. Rodríguez, New Jersey’s Acting Director of the Division of Consumer Affairs, issued an Administrative Order permitting licensed pharmacists in New Jersey to order and administer testing for COVID-19....more
Introduction -
The Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) have announced an array of guidance to combat the spread of COVID-19 and ease provider regulatory...more
On April 15, 2020, the Food and Drug Administration (FDA) updated its three hand sanitizer guidance documents to address the use of fuel- and technical-grade ethanol as an active pharmaceutical ingredient (API) in hand...more
As the 2019 novel coronavirus (COVID-19) is expected to reach its apex in several states over the next two weeks, the Department of Health & Human Services (HHS) has issued new guidance authorizing licensed pharmacists to...more
Philip Murphy, governor of New Jersey, signed Executive Order No. 112 on April 1, 2020, authorizing the New Jersey Division of Consumer Affairs (the DCA) to temporarily reactivate the licenses of recently retired health care...more
Food and Drug Administration -
Although some distilleries have tried to pitch in to produce hand sanitizer in the wake of a national shortage caused by the coronavirus public health emergency, hand sanitizers are actually...more
In response to the Coronavirus Disease 2019 (COVID-19), the Centers for Medicare & Medicaid Services (CMS) supplemented its guidance to dialysis facilities on March 10, 2020, to provide guidance regarding infection control to...more
The Centers for Medicare and Medicaid Services (CMS) published the Price Transparency Requirements for Hospitals to Make Standard Charges Public Final Rule (the Final Rule, effective January 1, 2021), in the Federal Register...more
12/10/2019
/ Administrative Law Judge (ALJ) ,
Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Fee-for-Service ,
Final Rules ,
First Amendment ,
Health Care Providers ,
Healthcare Reform ,
Hospitals ,
Price Transparency ,
Public Disclosure ,
Regulatory Requirements ,
Rulemaking Process ,
Service Charges