The Florida Board of Pharmacy permits pharmacies serving residents and patients at long-term care facilities (nursing homes, ALFs, homes for DD residents, etc.) as either Special Closed System Pharmacies or Community...more
5/23/2024
/ Anti-Kickback Statute ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Kickbacks ,
Long Term Care Facilities ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drug Coverage ,
Prescription Drugs
The Florida legislature took aim at pharmacy benefit managers (PBMs) during the 2023 legislative session by enacting the Prescription Drug Reform Act, Chapter 2023-29, Laws of Florida (https://laws.flrules.org/2023/29) (the...more
Whoever authored this new legislation (Chapter 2021-135, Laws of Florida) deserves a pat on the back for an idea whose time has come. When an applicant files for a change of ownership (“CHOW”) or change of location for one...more
For most Florida prescribers whose licenses haven’t renewed since 2019, it’s time to commence electronic prescribing. In 2019, the legislature enacted legislation that required electronic prescribing. However, this...more
Pharmacists and other providers should beware of a medical consent requirement buried in the new “Parents’ Bill of Rights” signed by Governor Desantis. The law will be codified at Fla. Statutes § 1014.06 and became effective...more
The catchphrase of the day is “social distancing” and it is the primary means of flattening the COVID-19 pandemic (the pandemic) curve by keeping contagious and healthy people apart. However, there is another kind of...more
Most states have issued emergency health declarations as a result of the COVID-19 epidemic. Most of these declarations require third-party payors (health plans, HMOs, etc.) to reimburse pharmacies for early prescription...more
At both the federal level and within Florida, there are the beginnings of the seeds of change regarding drug importation policies. President Trump and Governor DeSantis have both been HUGE supporters of drug importation as a...more
8/26/2019
/ Canada ,
Drug Distribution ,
Drug Pricing ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Florida ,
Food and Drug Administration (FDA) ,
Imports ,
Medical Devices ,
NPRM ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Requirements
International export pharmacies took another step forward towards a separate, distinct licensure in Florida as the Florida Board of Pharmacy held a specially called Rules Sub-Committee Meeting on June 27, 2019, to address the...more
7/24/2019
/ Biologics ,
Exports ,
Florida ,
Imports ,
Licensing Rules ,
Medical Devices ,
Permits ,
Pharmaceutical Distribution ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Regulatory Standards ,
State and Local Government
Governor Desantis recently signed House Bill 831, which will require certain healthcare practitioners to “electronically transmit prescriptions”. Unfortunately, the legislature left this term undefined, creating some...more
7/2/2019
/ Controlled Substances ,
Electronic Health Record Incentives ,
Electronic Prescribing ,
Florida ,
Health Care Providers ,
New Legislation ,
Pharmacies ,
Prescription Drugs ,
Regulatory Requirements ,
State and Local Government ,
Telehealth ,
Telemedicine
We are all familiar with prescription drug television commercials where it sounds like they hired a professional auctioneer to recite the drug side effects so fast you can hardly understand them....more
10/19/2018
/ Advertising ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Disclosure Requirements ,
Drug Pricing ,
Marketing ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Requirements ,
Rulemaking Process
The Florida legislature passed HB 21, which imposes a number of new requirements on prescribers and pharmacists regarding controlled substance prescribing and dispensing. Part of the law requires pharmacists to verify the...more
At the close of the 2018 session, the Florida Legislature passed Senate Bill (SB) 675, which if allowed to become law by the Governor, will help hospitals and their facilities that are under common control manage their...more
3/19/2018
/ Controlled Substances ,
Drug Distribution ,
Florida ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Pending Legislation ,
Pharmacies ,
Prescribing Authority ,
Prescription Drugs ,
Regulatory Oversight
Prior to the Comprehensive Addiction and Recovery Act of 2016 (CARA) only “physicians” could dispense and prescribe narcotic drugs for maintenance and detoxification treatment. CARA expanded who may prescribe for maintenance...more
1/30/2018
/ Comprehensive Addiction and Recovery Act of 2016 (CARA) ,
DEA ,
Drug & Alcohol Abuse ,
Florida ,
Health Care Providers ,
Nurse Practitioners ,
Opioid ,
Pain Management ,
Pharmaceutical Industry ,
Physician Assistants ,
Prescription Drugs ,
Regulatory Oversight ,
SAMHSA
The Affordable Care Act (ACA), as a whole, did not have a significant impact on pharmacy services per se. However, a complete repeal would likely impact certain areas of pharmacy services including the drug benefit for the...more
1/31/2017
/ Affordable Care Act ,
Drug Pricing ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Medicaid ,
Medicare ,
Medicare Part D ,
Patients ,
Pharmacies ,
Prescription Drugs ,
Repeal ,
Section 340B ,
Trump Administration
During the 2016 legislative session, Florida granted authority to both advanced registered nurse practitioners (ARNPs) and physician assistants (PAs) to prescribe controlled substances, subject to approval by their...more
The Florida Board of Pharmacy (BOP) recently amended the rules regarding community pharmacy hours of operation to reduce required daily operating hours from 40 to 20 hours per week. As before, the hours have to be posted and...more
The 2016 Florida Legislature enacted substantial legislation (Ch. 2016-212, Laws of Florida) to bring Florida’s Drug and Cosmetic Act (Ch. 499, Florida Statutes) in line with the federal Drug Supply Chain and Security Act...more
4/20/2016
/ Drug Distribution ,
DSCSA ,
Exemptions ,
Health Care Providers ,
Hospitals ,
New Legislation ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Publix ,
Wholesale
Pharmacies, dispensing prescribers, and certain healthcare facilities in Florida will soon have an easier time complying with controlled-substance reporting requirements. Florida established its Prescription Drug Monitoring...more
The Florida Board of Pharmacy rules allow pharmacies to engage in office-use compounding. Rule 64B16-27.700, FAC. This allows pharmacies to compound drugs for physicians to use in treating their patients in the office without...more
A new declaratory statement from Florida regulators clarifies the restrictions on intracompany sales of pharmaceuticals. Previously, if one pharmacy in Florida wanted to send a bottle of prescription medicine to its sister...more
As previously reported, HHS announced earlier this month that it would be providing clarification on the HIPAA Privacy Rule as it relates to marketing and prescription refill reminder programs. On September 19, 2013, HHS...more