Current through Reg. 50, No. 187; September 24, 2024
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.
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.
