Illinois has joined other states in efforts to require licensure for individuals located outside of the state. In the December 15, 2023 Register, the Illinois Department of Financial and Professional Regulation (“IDFPR”)...more
On Sept.12, 2023, the New York State Education Department announced its new plan to address central fill arrangements. The Department informed stakeholders who had submitted comments to its proposed central fill rule that it...more
On September 12, 2023, the Florida Board of Pharmacy published a notice of intent to adopt amendments to its rule on registered pharmacy technician-to-pharmacist ratios (64B16-27.410). The amendments would allow a supervising...more
On August 31, 2023, DEA published a final rule (“Final Rule”) regarding its management of controlled substance and List 1 Chemical (“L1 Chemical”) quotas for DEA-registered manufacturers. The Final Rule largely tracks DEA’s...more
9/6/2023
/ Controlled Substances ,
DEA ,
Final Rules ,
Food and Drug Administration (FDA) ,
Inventory ,
Life Sciences ,
Manufacturers ,
Notice of Proposed Rulemaking (NOPR) ,
Pharmaceutical Industry ,
Procurement Guidelines ,
Product Development Protocols ,
Product Labels ,
Quotas ,
Schedule I Drugs ,
Supply Chain
Over the last decade, the increased use of Controlled Substance Ordering System (“CSOS”) applications (i.e., platforms used to electronically transmit controlled substance orders) and Electronic Prescriptions for Controlled...more
On March 16, 2023, the Food and Drug Administration (FDA) released final guidance regarding definitions of "suspect product" and "illegitimate product" as part of a continued effort to prepare trading partners for the...more
3/22/2023
/ Counterfeit Drugs ,
Drug Distribution ,
DSCSA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Stolen Goods
On December 29, 2022, the Consolidated Appropriations Act of 2023 (Public Law No. 117-328) (the “Legislation”) was signed into law, which, under Section 1262 of the Legislation, contains the Mainstreaming Addiction Treatment...more
At a special called meeting on January 4, 2023, the Kentucky Board of Pharmacy (“Board”) was set to address public comment on new regulation, 201 KAR 2:460, and proposed amendments to 201 KAR 2:030. The amendments to 201 KAR...more
Last week the Supreme Court ("the Court") released a decision holding that the Federal Controlled Substance Act (the "Act") provision that criminalizes the dispensing of a controlled substance “except as authorized” includes...more
7/5/2022
/ 21 U.S.C. § 841 ,
Controlled Substances ,
Controlled Substances Act ,
Criminal Liability ,
DEA ,
Food & Drug Regulations ,
Health Care Providers ,
Healthcare ,
Intent ,
Jury Instructions ,
Mens Rea ,
Opioid ,
Pharmaceutical Industry ,
Prescribing Authority ,
Prescription Drugs ,
Reasonable Doubt ,
Ruan v United States ,
SCOTUS ,
Statutory Violations ,
Subjective Standard
On June 10, 2022, the Mississippi Board of Pharmacy filed their much-anticipated proposed rule on pharmacy shared services, starting the clock on the 25-day public comment period.
The Board simultaneously filed its...more
On May 3, 2022, the Texas Board of Pharmacy reviewed proposed amendments to its Central Fill Rule, 22 Tex. Admin. Code § 291.125, and voted to send the revised language for final adoption in the next Board meeting tentatively...more
At the April 13, 2022 Georgia Board of Pharmacy meeting, the Board discussed changes to Chapter 480-36 which governs retail pharmacy remote drug order processing.
The discussion was aimed at new verbiage that would require...more
At its August 31, 2021 meeting, the Nevada Board of Pharmacy moved to seek a formal opinion from the Nevada Attorney General Office regarding the legality of the requirement of all non-resident pharmacists who dispense or...more
If you are a Nevada licensed non-resident pharmacy, you will soon be receiving notification from the Nevada Board of Pharmacy (“Board”) stating that any pharmacist who dispenses or compounds prescriptions for a controlled...more