Florida Administrative Codes

4.1 Florida Board of Pharmacy

The Florida Board of Pharmacy (64B16, F.A.C.) is the regulatory body authorized to adopt rules, oversee licensure, enforce practice standards, and discipline pharmacists and pharmacies in Florida. It enacts and enforces the administrative rules that implement the Florida Pharmacy Act (Chapter 465, F.S.). The Board’s rules govern all aspects of pharmacy practice, including conduct, standards, permits, and disciplinary guidelines. For example, the Board’s disciplinary guidelines outline penalties for practicing without a permit or violating laws. The Board’s authority ensures public safety and consistent standards across all licensed pharmacy professionals and permittees in Florida.

Licensure Issues

Florida Administrative Code rules under 64B16‑26, F.A.C. set requirements for pharmacist licensure, renewal, and qualifications. These rules define educational prerequisites, internship requirements, examination criteria, and continuing education expectations. For example, Rule 64B16‑26.6012 allows Board‑ordered disciplinary continuing education, including a 12‑hour Laws & Rules course, to fulfill requirements after a violation. Licensure rules also include renewal timelines and CE mandates to ensure pharmacists remain competent. A pharmacist who fails to meet the CE requirements or complete a Board‑approved internship may be denied renewal or subject to disciplinary action.

Pharmacy Practice Standards

Pharmacy practice standards in Rules 64B16‑27.800, 64B16‑27.820, and 64B16‑27.830, F.A.C., define minimum operational expectations. Rule 64B16‑27.800 requires pharmacies to maintain patient records with demographic and medication history details.

Rule 64B16‑27.820 mandates patient counseling for new and refill prescriptions. Rule 64B16‑27.831 outlines-controlled substance prescription validation and continuing education requirements, including use of the PDMP and professional judgment in validating prescriptions. For example, a pharmacist must offer counseling and document patient allergies and medication history before dispensing to ensure safe therapeutic outcomes.

Standards for Pharmacy Permits

Rules in 64B16‑28, F.A.C. establish requirements for pharmacy permits before dispensing medications. Rule 64B16‑28.451 allows pharmacies under common ownership to perform prescription drug processing using a shared database, with required policies and recordkeeping.

Permit standards govern facility requirements, database controls, quality assurance, and patient confidentiality. For example, a pharmacy operating under a prescription drug processing permit must maintain a secure electronic system that tracks which pharmacist or technician performed each processing function.

Disciplinary Guidelines

Rules 64B16‑30.001 and 64B16‑30.003, F.A.C., set disciplinary guidelines and citation procedures for pharmacists, interns, and permittees. Rule 64B16‑30.001 outlines ranges of penalties for violations (e.g., incompetence, operating without a permit, or

failing to maintain standards). For example, practicing on an inactive license may result in fines and renewal orders under Rule 64B16‑30.003. Disciplinary guidelines help ensure fair, consistent sanctions and corrective actions for regulatory violations.

Nonresident Pharmacies

Rule 64B16‑32.001, F.A.C., requires out‑of‑state pharmacies to obtain a nonresident pharmacy permit before shipping or delivering medications into Florida. This permit does not authorize shipment of compounded sterile products unless specific requirements are met.

Applicants must submit a Florida‑approved application and comply with relevant statutory requirements. For example, a mail‑order pharmacy in another state must secure a nonresident permit before legally dispensing prescriptions to Florida patients.

Prescriber Rules Related to Pharmacy Practice – Weight Loss/Obesity & Telemedicine

Florida law requires prescribers to issue valid prescriptions meeting statutory elements; though not in 64B16, electronic prescribing is enforced by related Florida statutes requiring practitioners to transmit prescriptions electronically unless exceptions apply (e.g., hospice patients). Telemedicine laws allow practitioners to evaluate patients via telehealth, but controlled substances generally cannot be prescribed via telehealth except under specific conditions (e.g., psychiatric disorders). For example, a prescriber must generate an electronic prescription for a weight‑loss medication unless an exception applies, and cannot prescribe a Schedule II via telehealth without qualifying circumstances.

Test Your Knowledge:

Question 1: Which responsibility falls under the authority of the Florida Board of Pharmacy as established in Rule Chapter 64B16, F.A.C.?

A. Enacting criminal penalties for controlled substance trafficking
B. Adopting administrative rules and disciplining pharmacists and pharmacies
C. Approving medical school curricula for prescribers
D. Regulating hospital accreditation standards

Correct Answer:

B. Adopting administrative rules and disciplining pharmacists and pharmacies

Question 2: Under Rule 64B16-27.820, F.A.C., which action is required of a pharmacist when dispensing prescriptions?

A. Counseling only for controlled substances
B. Counseling only for new prescriptions
C. Offering patient counseling for both new and refill prescriptions
D. Counseling only if requested by the prescriber

Correct Answer:

C. Offering patient counseling for both new and refill prescriptions