64B16-28.108. All Permits - Labels and Labeling of Medicinal Drugs

Each container of medicinal drugs dispensed shall have a label or shall be accompanied by labeling. Every pharmacy that dispenses a medicinal drug to a patient or agent of the patient shall ensure that the pharmacy’s policy and procedures manual covers dispensing to the blind or visually impaired. The manual must make certain to address that those with visual impairments are fully informed of all the information required to be part of the label or labeling.

(1) Definitions.

(a) “Controlled substance” means any substance named or described in Schedules II-V of Section 893.03, F.S.

(b) “Customized medication package” means a package that:

1. Is prepared by a pharmacist for a specific patient.

2. Is a series of containers.

3. Contains two (2) or more solid oral dosage forms.

(c) “Labeling” means a label or other written, printed, or graphic material upon an agent or product or any of its containers, wrappers, drug carts, or compartments thereof, as well as a medication administration record (MAR) if a medication administration record is an integral part of the unit dose system.

(d) “Radiopharmaceutical” means any substance defined as a drug in Section 201(g)(1) of the Federal Food, Drug and Cosmetic Act which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any of those drugs intended to be made radioactive. This includes nonradioactive reagent kits and nuclide generators which are intended to be used in the preparation of any such substance, but does not include drugs which are carbon-containing compounds or potassium-containing compounds or potassium-containing salts which contain trace quantities of naturally occurring radionuclides.

(e) “Serial number” means a prescription number or other unique number by which a particular prescription or drug package can be identified.

(2) The label affixed to each container dispensed to a patient shall include:

(a) Name and address of the pharmacy.

(b) Date of dispensing.

(c) Serial number.

(d) Name of the patient or, if the patient is an animal, the name of the owner and the species of animal.

(e) Name of the prescriber.

(f) Name of the drug dispensed (except where the prescribing practitioner specifically requests that the name is to be withheld).

(g) Directions for use.

(h) An Expiration Date or Beyond-Use Date: The expiration date must be the date provided by the manufacturer, repackager, or other distributor. The beyond-use date must not exceed the expiration date and it shall not be a date greater than one year from the date the medicinal drug is filled. The board finds that the use of a “discard-after-date” or “do not use after date” to be equivalent of a beyond-use date.

(i) If the medicinal drug is a controlled substance, a warning that it is a crime to transfer the drug to another person.

(3) The label on the immediate container of a repackaged product or a multiple unit prepackaged drug product shall include:

(a) Brand or generic name.

(b) Strength.

(c) Dosage form.

(d) Name of the manufacturer.

(e) Expiration date.

(f) Lot number:

1. Manufacturer’s lot number; or

2. Number assigned by the dispenser or repackager which references the manufacturer’s lot number.

(4) A medicinal drug dispensed in a unit dose system by a pharmacist shall be accompanied by labeling. The requirement will be satisfied if, to the extent not included on the label, the unit dose system indicates clearly the name of the resident or patient, the prescription number or other means utilized for readily retrieving the medication order, the directions for use, and the prescriber’s name.

(5) A unit dose system shall provide a method for the separation and identification of drugs for the individual resident or patient.

(6) A customized patient medication package may be utilized if:

(a) The consent of the patient or the patient’s agent has been secured; and,

(b) The label includes:

1. Name, address and telephone number of the pharmacy.

2. Serial number for the customized medication package and a separate serial number for each medicinal drug dispensed.

3. Date of preparation of the customized patient medication package.

4. Patient’s name.

5. Name of each prescriber.

6. Directions for use and any cautionary statements required for each medicinal drug.

7. Storage instructions.

8. Name, strength, quantity and physical description of each drug product.

9. A beyond use date that is not more than 120 days from the date of preparation of the customized patient medication package but shall not be later than any appropriate beyond use date for any medicinal drug included in the customized patient medication package. A pharmacy utilizing customized patient medication packages shall have policies and procedures that specifically address change to patient medication regimens.

(c) The customized patient medication package can be separated into individual medicinal drug containers, then each container shall identify the medicinal drug product contained.

(7) The label affixed to the immediate outer container shield of a radiopharmaceutical shall include:

(a) Name and address of the pharmacy.

(b) Name of the prescriber.

(c) Date of the original dispensing.

(d) The standard radiation symbol.

(e) The words “Caution Radioactive Material.”

(f) Name of the procedure.

(g) Prescription order number.

(h) Radionuclide and chemical form.

(i) Amount of radioactivity and the calibration date and time.

(j) Expiration date and time.

(k) If a liquid, the volume.

(l) If a solid, the number of items or weight.

(m) If a gas, the number of ampules or vials.

(n) Molybdenum 99 content to the United States Pharmacopeia (UPS) limits.

(o) Name of the patient or the words “Physician’s Use Only.”

(8) The label affixed to the immediate inner container of a radiopharmaceutical to be distributed shall include:

(a) The standard radiation symbol.

(b) The words “Caution Radioactive Material.”

(c) Radionuclide and chemical form.

(d) Name of the procedure.

(e) Prescription order number of the radiopharmaceutical.

(f) Name of the pharmacy.

(9) The labeling on a carton or package containing a medicinal drug or product dispensed from an Extended Scope Renal Dialysis (ESRD) pharmacy shall include:

(a) “Use as Directed” statement.

(b) The name and address of the person to whom the products will be delivered.

(c) Name of the prescriber.

(d) Name and address of the ESRD pharmacy location from which the products were shipped.

(e) Prescription number.

(f) Any special instructions regarding delivery dates or locations.

(g) Beyond use date or, if the medicinal drug or product is dispensed in an unopened sealed package, the manufacturer’s expiration date.

(10) The labeling affixed to patient specific medications (this does not include plain IV solutions or floor stock) dispensed from an Institutional Class II, Modified Class II Type B, or Class III permit shall include:

(a) Names of active ingredients;

(b) Amounts or concentrations of active ingredients;

(c) Beyond use date and time;

(d) Storage requirements (if applicable);

(e) Identification of responsible compounding personnel and/or dispensing pharmacist;

(f) Labels for batch-prepared CSPs must also include:

1. Control or lot number;

2. Auxiliary labeling (including precautions); and

3. Device-specific instructions;

(g) Labels for patient specific medications must also include:

1. Patient’s name;

2. Location the medication is to be delivered to; and

3. Directions for use and applicable accessory and cautionary instructions.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.022(1), 465.0255 FS. History–Amended 5-19-72, Repromulgated 12-18-74, Amended 10-10-78, 9-18-84, 1-20-85, Formerly 21S-1.13, Amended 10-2-88, Formerly 21S-1.013, Amended 7-31-91, 10-1-92, 4-19-93, 7-12-93, Formerly 21S-28.108, 61F10-28.108, 59X-28.108, Amended 3-31-05, 4-22-13, 6-24-21, 11-28-21, 7-18-23.