In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more
6/27/2025
/ Distributors ,
Government Agencies ,
Healthcare ,
Imports ,
Licenses ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
New Regulations ,
Non-Residents ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Puerto Rico ,
Regulatory Reform ,
Regulatory Requirements
On April 15, 2025, the Centers for Medicare & Medicaid Services (“CMS”) published the Contract Year 2026 Policy and Technical Changes Final Rule which amends the regulations governing various Medicare programs, including the...more
4/24/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Final Rules ,
Health Insurance ,
Healthcare ,
Manufacturers ,
Medicare ,
Medicare Part D ,
Pharmacies ,
Prescription Drugs ,
Reimbursements
A recent Securities and Exchange Commission (“SEC”) settlement with DMK Pharmaceuticals Corporation (“DMK Pharmaceuticals”) and its Chief Financial Officer (“CFO”) serves as a good reminder that SEC-regulated entities...more
1/31/2025
/ Anti-Kickback Statute ,
Corporate Governance ,
Enforcement Actions ,
Fraud ,
Healthcare ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Securities and Exchange Commission (SEC) ,
Securities Regulation ,
Securities Violations ,
Settlement ,
Veterinarians
Effective December 30, 2024, significant revisions to the Missouri Board of Pharmacy’s Rule 20 CSR 2220-2.013 (Prescription Delivery Requirements) will kick in, introducing new patient safety measures for pharmacies that mail...more
The FDA released a Declaratory Order on December 19th re-evaluating and essentially re-instituting its previous position on the tirzepatide shortage, declaring the shortage resolved. As a bit of history, on October 2, 2024...more
On November 22, 2024, the Governor of New York signed into law a closely watched bill that expressly authorizes pharmacy shared services arrangements in the state. These models were not previously addressed in New York’s...more
12/2/2024
/ Healthcare ,
Licensing Rules ,
New Legislation ,
New York ,
Pharmaceutical Industry ,
Pharmacies ,
Policies and Procedures ,
Prescription Drugs ,
Product Labels ,
Regulatory Reform ,
Service Agreements
On November 19, 2024, the Massachusetts Board of Registration in Pharmacy (the “Board”) published several memoranda that described the impending non-resident pharmacy licensure requirements and the anticipated timeline for...more
The Food and Drug Administration (“FDA”) has released draft interim guidance documents that impact the use of bulk drug substances in compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act...more
1/11/2024
/ Department of Health and Human Services (HHS) ,
DQSA ,
Draft Guidance ,
Drug Compounding ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Interim Guidance ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Section 503
In a previous update, Quarles discussed a new Alabama law that requires individuals serving as the designated representative for an Alabama-licensed facility to register with the Alabama Board of Pharmacy ("the Board”) as of...more
12/15/2023
/ Alabama ,
Drug Distribution ,
Healthcare ,
Healthcare Facilities ,
Licensing Rules ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
Registered Representatives ,
Regulatory Requirements ,
Third-Party Service Provider
On October 8, 2023, California Governor Gavin Newsom signed Assembly Bill 1286 into law. The new law, sponsored by Assemblymember Matt Haney and the California Board of Pharmacy, aims to reduce medication errors and...more
11/16/2023
/ California ,
Drug Safety ,
Employee Misconduct ,
Employee Training ,
Healthcare ,
Life Sciences ,
New Legislation ,
Patient Safety ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacist ,
Physicians ,
Prescription Drugs ,
Regulatory Reform
The Food and Drug Administration (“FDA”) released additional guidance documents on Wednesday, August 30th pertaining to the enhanced drug distribution security requirements under the Drug Supply Chain Security Act (“DSCSA”). ...more
9/1/2023
/ Drug Distribution ,
DSCSA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply Chain
On August 15, 2023, the U.S. Court of Appeals for the Tenth Circuit issued an opinion in Pharmaceutical Care Management Association v. Glen Mulready, in his official capacity as Insurance Commissioner of Oklahoma, Oklahoma...more
8/30/2023
/ Employee Benefits ,
Employee Retirement Income Security Act (ERISA) ,
Health and Welfare Plans ,
Health Insurance ,
Healthcare ,
Hospitals ,
Medicare Part D ,
Patients ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Physicians ,
Preemption
On May 31, 2023, the Nevada Legislature enacted Assembly Bill 107, which reversed the Nevada Board of Pharmacy’s (the “Board”) interpretation that required Nevada pharmacist licensure for out-of-state pharmacists who dispense...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
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 February 4, 2022, the FDA released its long-awaited proposed national standards for the licensure of third party logistics providers (3PLs) and wholesale drug distributors. The draft rules were years over-due and the delay...more
5/17/2022
/ Change of Ownership ,
Comment Period ,
Drug Distribution ,
DSCSA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Licensing Rules ,
Life Sciences ,
Logistics ,
Pharmaceutical Industry ,
Pharmacies ,
Preemption ,
Regulatory Requirements ,
Supply Chain ,
Third-Party Service Provider ,
Wholesale