3.1 - Prescription vs. OTC drugs, Generic Substitution, and Filling Prescriptions

FS 465.025 Substitutions

- If your doctor prescribes a brand-name medicine, the pharmacist will usually give you a cheaper generic version that works the same—unless you ask for the brand-name one instead

- A generic drug can only be used if it’s made and sold by a company in the U.S., is on the approved drug list, and the doctor has not said the brand-name drug is “medically necessary” (either written or said verbally).

FS 465.025 pricing

- The pharmacist has to tell you how much cheaper the generic drug is and let you know that you can say no if you don’t want it.

- If they do give you the cheaper generic version, they must make sure you get the full savings (you pay the lower price).

FS 64B16-27.530

The pharmacist must tell you if they switch your brand-name drug to a generic, explain any price difference, and let you know that you can say no. They should explain this in a way that’s clear and easy for you to understand. (created to enforce FS 465.025)

FS 465.025 notices

- Every pharmacy must clearly post a large sign telling you to ask the pharmacist about cheaper generic options and what Florida law says about them

- “CONSULT YOUR PHARMACIST CONCERNING THE AVAILABILITY OF A LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG AND THE REQUIREMENTS OF FLORIDA LAW.”

FS 64B16-27.520 Positive Drug Formulary

- Every pharmacy must keep an approved list of brand-name and generic drugs, and these drugs must come from manufacturers or distributors that are officially approved by the FDA.

FS 465.025 Inequivalence and negative formulary

- The pharmacy and medical boards make a list of generic drugs that are not safe to substitute because they don’t work the same as the brand-name drug and could harm patients.

FS 64B16-27.500 negative formulary

digitoxin, conjugated estrogen, dicumarol, chlorpromazine, theophylline, pancrelipase

FS 465.0251 Negative Formulary Removal

If all versions of a generic drug are proven to work the same as the brand-name drug (FDA “A-rated”), the boards will remove it from the “do not substitute” list, meaning it is safe to substitute.

FS 465.0252 Biosimilar Substitutions

Biologic drugs, biosimilars, and interchangeable products have the same definitions as federal law.

Biosimilar substitutions criteria

A biologic drug can be substituted only if the FDA says it is biosimilar and interchangeable, the prescriber does not object, and the patient is informed like with generic drugs. The substitution must be recorded and kept for 2 years. In hospitals, it must be documented in the patient’s medical record. The state pharmacy board must also keep an updated public list of approved interchangeable biologic drugs online.

FS 465.0255 expiration date

- clearly show the expiration date on the drug package

- expiration date is shown on the bottle label or provided in writing to the patient

FS 465.0255 beyond use date (BUD)

- no more than 1 year after the medication is dispensed

- pharmacist must also tell the patient the expiration date if asked and give instructions on how to properly use and store the medication

FS 465.026 Transfer prescriptions

A pharmacist can transfer and fill a valid prescription from another pharmacy (even from out of state), including electronically. Before doing so, the pharmacist must tell the patient the old prescription at the other pharmacy will be canceled, confirm the prescription is still valid and can be filled as intended, and document key details like the original pharmacy, prescription number, drug name, amount dispensed, date filled, and remaining refills.

Transfer prescription requirements

When another pharmacy requests a prescription transfer, the pharmacist must verify it is valid, send all required information accurately, and document who requested it and when. The original prescription must be marked as “void” or canceled in the system.

If the transferred prescription is not used within a reasonable time, the pharmacist must notify the original pharmacy, which can reactivate the prescription.

FS 465.026 transfers out of state

If a prescription is transferred from another state, the Florida pharmacist must confirm that the other pharmacy or pharmacist is properly licensed in that state before accepting the transfer.

FS 465.0265 Centralized Rx Filling

Pharmacies under the same owner or with a contract can share prescription filling tasks (“central fill”). Each pharmacy must have written procedures that explain how they follow laws, track prescriptions and responsible pharmacists, label all pharmacies involved, protect patient privacy, and run quality checks to ensure safe care. This shared filling process is not considered a prescription transfer. The Board of Pharmacy sets the rules for this system.

FS 465.0266 Common database policies and procedures

Pharmacies with the same owner can share a common computer system to fill prescriptions, and this is not considered a transfer if all pharmacies and pharmacists are properly licensed. The system must track every pharmacist involved, keep detailed records of each step of filling the prescription, protect patient privacy, and include policies for legal compliance and quality improvement.

FS 465.027 exceptions (general)

- does not restrict the sale of over-the-counter “home remedy” or branded products sold in their original, unopened packaging

- allows companies to sell non-prescription products freely

FS 465.027 dialysis exceptions

does not apply to FDA-approved dialysis-related drugs or equipment made for home kidney dialysis, as long as they are properly prescribed and delivered in sealed packaging to the patient (or caregiver) or to a healthcare provider for use in treating chronic kidney failure

FS 465.0275 emergency Rx refill

If a pharmacist cannot quickly reach the doctor for refill approval, they may give a one-time emergency supply: either up to a 72-hour supply of the medication or one vial of insulin for diabetes.

FS 465.0275 state of emergency

If the Governor declares a state of emergency, pharmacists can give up to a 30-day supply of a medication in the affected areas, as long as certain conditions are met.

emergency refill caveats

During a declared emergency, a pharmacist may give up to a 30-day supply of medication if it is not a controlled Schedule II drug, is important for ongoing treatment or life support, and stopping it could harm the patient or cause discomfort. The pharmacist must write and sign a record of the prescription and notify the prescriber afterward.