Florida Administrative Code
64 - DEPARTMENT OF HEALTH
64B16 - Board of Pharmacy
Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS
Section 64B16-28.502 - Class I, Class II and Class III Institutional Permit - Labels and Labeling of Medicinal Drugs for Inpatients of a Nursing Home

Universal Citation: FL Admin Code R 64B16-28.502

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

(1) The label affixed to a container used in conventional dispensing to a Class I, Class II or Class III Institutional permit which, within the scope of its practice, services only the inpatients of a nursing home as defined by subsection 400.021(5), F.S., shall contain at least the following information:

(a) The name of and address of the pharmacy;

(b) The name of the prescriber;

(c) The name of the patient;

(d) The date of the original filling or the refill date;

(e) The prescription number or other prescription identification adequate to readily identify the prescription;

(f) The directions for use;

(g) The name of the medicinal drug dispensed (except where the health care practitioner prescribing the drug specifically denotes that the name is to be withheld);

(h) The quantity of the drug in the container.

(2) The label affixed to a container used in dispensing substances listed in any of the schedules appearing in chapter 893, F.S., in regard to conventional dispensing shall contain at least the following information:

(a) All of the information required by subsection (1) of this rule;

(b) The number of the prescription as recorded in the prescription files of the pharmacy in which it is filled; and,

(c) A clear, concise warning that it is a crime to transfer the controlled substance to any person other than the patient for whom prescribed.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.022(1) FS.

New 7-31-91, Amended 10-1-92, Formerly 21S-28.502, 61F10-28.502, 59X-28.502, Amended 8-16-10, 9-27-18.

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