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
Indiana recently enacted significant new legislation that will impact how pharmacy benefit management services are provided in Indiana. Senate Bill 140 (SB 140), signed into law during the 2025 legislative session, imposes...more
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
On October 9, 2024, the Food and Drug Administration (“FDA”) issued a document that provides exemptions to the enhanced drug distribution security requirements (enhanced requirements) required by section 582(g) of the Food,...more
10/11/2024
/ Drug Distribution ,
DSCSA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Regulatory Requirements ,
Supply Chain
The Drug Enforcement Administration (DEA) recently issued a new regulation codifying provisions of the Veterinary Medicine Mobility Act of 2014 (VMMA). The VMMA, which was signed into law in 2014, allows a veterinarian to...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
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
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 Friday, August 25th, the Food and Drug Administration (“FDA”) issued a guidance document extending the November 27, 2023 enforcement deadline for drug and device manufacturers, wholesale distributors, dispensers, and...more
8/30/2023
/ Drug Distribution ,
DSCSA ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Pharmacies ,
Regulatory Requirements ,
Supply Chain
On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more
8/23/2023
/ Drug Distribution ,
DSCSA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Manufacturers ,
New Guidance ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Requirements ,
Suppliers ,
Supply Chain ,
Waivers ,
Wholesale
The U.S. Food and Drug Administration (FDA) issued a draft guidance document, June 27, that describes FDA’s current thinking on the prohibition of wholesaling human drugs by a 503B outsourcing facility under the Food, Drugs,...more
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
Beginning on January 1, 2024, pursuant to recently passed Alabama House Bill 79 individuals serving as the designated representative for an Alabama-licensed facility will be required to hold an Alabama designated...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
Oklahoma may be the first state in the Union to require temperature-controlled shipping containers when mailing prescription medications, that is if the state adopts the Board of Pharmacy's proposed regulation....more
While the vast majority of states require non-resident wholesale distributors and manufacturers that ship prescription drugs into their states to obtain a non-resident license, Puerto Rico had been one of the few that did not...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