Day: September 28, 2023

Amanda Howard, Esq.

APRNsare highly educated and trained healthcare professionals. In Florida, Advanced Practice Registered Nurses (APRNs) have an expanded scope of practice whichallows APRNs whose protocols allow, to prescribe and dispense medications to patients under certain conditions and in accordance with state regulations. Medication dispensing by APRNs can improve patient access to essential medications.

F.A.C. Rule 64B9-4.011 addresses the requirements for APRNs in Florida who wish to dispense medications. Key components of this rule include:

Registration with the Board of Nursing: APRNs whose protocols allow them to dispense medications must register with the Florida Board of Nursing.

Application Submission: APRNs seeking to dispense medications must complete an application form provided by the Board of Nursing. This application form can be obtained from the Board’s official website or office.

Financial Requirement: APRNs must enclose a $100 cashier’s check or money order, payable to the Department of Health, along with their completed application. This fee helps cover the administrative costs associated with processing and maintaining medication dispensing registrations.

Mail the Application: Send the completed application and the fee to the address provided on the application form. It’s advisable to use certified mail or a similar method to ensure the delivery is tracked.

Processing Time: The Board of Nursing will review your application and, if all requirements are met, grant you permission to dispense medications. Be prepared for processing times that may vary, so plan accordingly.

It’s important for APRNs in Florida to stay informed about these regulations and adhere to them diligently. Compliance not only preserves the integrity of the profession but also promotes the highest standards of patient care in the state.

Get Help

As a boutique law firm dedicated to supporting the healthcare community, our goal is to ensure our clients are protected. Please contact us at Florida Healthcare Law Firm to set up a consultation today.

Amanda Howard, Esq.

In today’s health-conscious world, dietary supplements have become a significant part of many people’s daily routines. These supplements promise a variety of benefits, from bolstering overall health to addressing specific wellness concerns. However, behind the scenes, a complex web of federal and state laws governs the manufacturing, labeling, and advertising of these dietary powerhouses.

Dietary supplements are classified as “food” under federal and state law, except when they meet the definition of a drug and therefore, are not subject to “drug” laws. Unlike drugs, the FDA generally does not have the authority to pre-approve the safety, effectiveness or labeling of dietary supplements before they hit the market. Instead, the FDA typically steps in post-market to ensure safety and compliance with regulations. Whether this is a good or bad thing is a discussion for another time.

However, don’t let the absence of pre-approval fool you; dietary supplements, much like their pharmaceutical counterparts, must adhere to stringent standards. These products cannot be adulterated, meaning they must meet purity and quality requirements, and they must not be misbranded, ensuring accurate and truthful labeling in accordance with federal regulations.

The FDA’s Regulatory Realm

Enter the FDA, the chief guardian of dietary supplement integrity. Defined under 21 U.S.C. 321(ff), dietary supplements fall within the FDA’s purview. The agency wields its regulatory power through the Dietary Supplement Health and Education Act of 1994 (DSHEA) and the Current Good Manufacturing Practice (cGMP) regulations for dietary supplements. These regulations are all-encompassing, covering every aspect of manufacturing, from personnel and facilities to equipment, production processes, and stringent quality control measures. Interestingly, the United States Pharmacopeia (USP) has issued General Chapter 2750, which outlines Manufacturing Practices for Dietary Supplements and the FDA regulations essentially mirror such guidelines.

The USP: Setting the Gold Standard

As it’s clear the USP had great influence in creation of the federal dietary supplement laws, manufacturers would be wise to participate in the USP’s Dietary Supplement Verification Program, which allows products that meet specific quality standards to proudly bear the USP Verified Mark, adding credibility and legitimacy.

FTC Vigilance in Advertising

While the FDA diligently oversees manufacturing and labeling, the Federal Trade Commission (FTC) takes charge of the advertising front. The FTC ensures that advertisements for dietary supplements are truthful, substantiated by scientific evidence, and devoid of any misleading claims.

Labeling Precision

Lastly, when it comes to dietary supplement labeling, compliance is key. Regulations within 21 CFR 101 et. seq. dictate what information must grace supplement labels. This ensures that consumers have unfettered access to accurate and essential details about the product.

Manufacturers, advertisers and sellers of dietary supplements must remain vigilant, familiarizing themselves with these multifaceted regulations and ensuring that their products meet the stringent safety and labeling standards. Ultimately, these regulatory frameworks are in place to safeguard the health and well-being of consumers, fostering transparency and confidence within the thriving dietary supplement industry.

Get Help

As a boutique law firm dedicated to supporting the healthcare community, our goal is to ensure our clients are protected. Please contact us at Florida Healthcare Law Firm to set up a consultation today.

Written By: Chase Howard 

Just like anything in healthcare, the trend comes first and the regulation follows. In this case, online prescribers, pharmacies, and others, are now under the pressure of a certain third-party verification platform called LegitScript to get certified or risk losing access to vital aspects of their business. 

From LegitScript directly: LegitScript Healthcare Merchant Certification provides a recognized stamp of approval for businesses that facilitate transactions for pharmacies. Many banks, advertising programs, social media platforms, and e-commerce websites require certification from a recognized organization like LegitScript to support your merchant account. Our certification is recognized by Visa, Mastercard, Google, Microsoft Bing, Facebook, and TikTok.

Read that again. Does that apply to your healthcare business? Have you ever heard of the term LegitScript? Do you like operating smoothly and without interruption? It’s time to get certified and avoid the stonewall that will prevent your healthcare business from making another dollar. 

• Who does thPharmacies including internet pharmacies, mail-order pharmacies, brick-andmortar pharmacies, local pharmacies with remote dispensing, internet veterinary pharmacies, and sterile compounding pharmacies.is apply to: 
• Telemedicine and telehealth providers that facilitate prescribing.
• Supply chain businesses including pharmaceutical manufacturers, wholesalers, and distributors.
• Other healthcare merchants such as prescription eyeglass and contact lens merchants, price comparison websites/apps, and discount pharmacy websites/apps.

Without certification from a recognized entity like LegitScript, many banks, advertising programs, social media platforms, and e-commerce websites will terminate your accounts. Sometimes, without notice. If you think you can react once this happens, think again. The application and approval process can take months, if you do it right. 

Don’t wait. Let’s get you certified today before its too late.