Florida Generic Substitution Laws

In drug stores and medical clinics, pharmacists dispense drug medications following the prescribing doctor's instructions. Pharmacists will give patients brand name products for their medical needs yet will also substitute generic medications based on several factors, often because the generic equivalent works just as well, but is more cost-effective for the patient. Florida has state regulations that govern how and when pharmacists can substitute a generic drug.

Generic Substitution Types

• The FDA places generic drugs into several different classification types depending on dosage strengths, formulas, appearance and body absorption of ingredients. Bioavailability generic drugs are based on the extent and rate the body can absorb the active ingredient and move toward the body site needing attention. Pharmaceutical generic equivalents have the same active ingredients, dosage and strength of brand names but may have a different appearance, inactive ingredients or packaging. Pharmaceutical alternatives have the same therapeutic ingredients but formulated with different ester or salt. Bioequivalent products are pharmaceutical equivalents and alternatives that has comparable bioavailability during experimentation. Therapeutic equivalents produce the same equivalent effects as pharmaceutical equivalents with safety profile but must be labeled properly when manufactured under Good Manufacturing Practice regulations.

  The FDA has produced an Orange Book listing generic drugs that can be used safely with brand name equivalents, though Florida law did not use the Orange Book listing as a reference for pharmaceutical statutes concerning generic substitutions.

Substitution and Recordkeeping

• Pharmacists must maintain a record of any medication substitution made using generic equivalent products for a prescribed brand name. Florida law mandates that pharmacists make generic drug substitutions only when all prescription requirements have been met.

Patient Consent and Cost Savings

• Florida state law requires pharmacists to give notification and receive consent from patients for any generic drug substitution. The pharmacist must also substitute generic drugs using cost savings methods by passing on the savings to the purchaser.

Formulary

• Community pharmacists will establish a formulary consisting of which drug products will not pose a threat to the patient's health and safety if a generic medication becomes exchanged with a brand name. According the the U.S. Pharmacist Journal, the pharmacist can create two types of formularies: positive, where the drugs are equivalent and interchangeable, or negative, where the the drugs are not equivalent and interchangeable. Under Florida state law, a pharmacist can create a positive formulary for appropriate prescription substitution.

Anti-epileptic Medication

• A pharmacist must give prior notification of and receive signed consent from the prescribing doctor to make a substitution of an anti-epileptic drug or formula of an anti-epileptic drug brand or generic equivalent for the treatment of seizures in epilepsy patients. Besides doctor approval, the pharmacist must also have consent form the patient, spouse, patient's parents or legal guardian.