64B16-28.108: All Permits - Labels and Labeling of Medicinal Drugs
64B16-28.120: All Permits - Storage of Legend Drugs; Prepackaging
64B16-28.502: Labels and Labeling of Medicinal Drugs Institutional Permit I. (Nursing Homes)
64B16-28.602: Class II Institutional Dispensing
64B16-28.6021: Class II Institutional Pharmacy - Emergency Department Dispensing
PURPOSE AND EFFECT: The Board proposes the rule amendment for clarification of requirements regarding the expiration date, storage of drugs, labels and labeling of medicinal drugs for inpatients of a nursing home, dispensing of medications, emergency department dispensing of medications.
SUMMARY: The requirements regarding the expiration date and the storage of drugs will be clarified.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared. The Board determined the proposed rule will not have an impact on small business.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 465.005, 465.019(4), 465.022 FS.
LAW IMPLEMENTED: 465.019(2)(b), 465.019(4), 465.0196, 465.022 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Rebecca R. Poston, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3253
THE FULL TEXT OF THE PROPOSED RULE IS:
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.
(1) No change.
(2) The label affixed to each container dispensed to a patient shall include:
(a) through (g) No change.
(h) Discard after Expiration date.
(i) No change.
(3) The label on the immediate container of a repackaged product or a multiple unit prepackaged drug product shall include:
(a) through (d) No change.
(e) Discard after 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) through (9) No change.
Rulemaking Specific Authority 465.005, 465.022 FS. Law Implemented 465.022(1) 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,________.
64B16-28.120 All Permits – Storage of Legend Drugs; Prepackaging.
(1) No change.
(2) All medicinal drugs or drug preparations as defined in Section 465.003(8), F.S., within Class I Institutional permittees as defined in Section 465.019(2)(a), F.S., and Special ALF Permit 64B16-28.870, F.A.C., shall:
(a) through (b) No change.
(3) Prepackaging of medication, whether a part of a unit dose system or a part of a multiple dose drug distribution system in an extended care facility or hospital holding a valid Class II Institutional pharmacy permit, must be done in accordance with procedures set up by the consultant pharmacist of record in the policy and procedure manual; and in the case of a pharmacy holding a valid community pharmacy permit must be done in accordance with procedures set up by the prescription department manager.
(4) Medicinal drugs and proprietary preparations as idenified above that are stored in treatment areas must be accessible only to licensed staff (pharmacists, nurses, physicians, advanced registered nurse practitioners, physician assistants, respiratory and physical therapist, radiology technicians and registered pharmacy technicians, etc.) in accordance with their license, practice act, or to other personnel specifically authorized by the institution.
Rulemaking Specific Authority 465.005, 465.022 FS. Law Implemented 465.022, 465.003(7), 435.019(2) FS. History–New 9-18-84, Formerly 21S-1.44, 21S-1.044, Amended 7-31-91, Formerly 21S-28.120, 61F10-28.120, 59X-28.120, Amended 2-8-07,_______.
64B16-28.502 Class I Institutional Permit and Class II Institutional Permit – Labels and Labeling of Medicinal Drugs for Inpatients of a Nursing Home Institutional Permit I. (Nursing Homes).
(1) The label affixed to a container used in conventional dispensing to a Class I Institutional permit or a Class II Institutional permit which, within the scope of its practice, services only the inpatients of a nursing home as defined by Section 400.021(5), F.S., shall contain at least the following information:
(a) through (g) No change.
(h) The quantity of the drug in the container.
(2) No change.
(3) All labels described in subsections (1) & (2) above shall have the quantity of the drug placed in the container on the labels.
Rulemaking Specific Authority 465.005, 465.022 FS. Law Implemented 465.022(1) FS. History–New 7-31-91, Amended 10-1-92, Formerly 21S-28.502, 61F10-28.502, 59X-28.502, Amended_________.
64B16-28.602 Institutional Class II Dispensing Class II Institutional Dispensing.
(1) Pharmaceutical preparations which are administered to patients of a hospital by the personnel of such institution shall only be taken from the original container, or from a container which has been prepared by a Florida licensed registered pharmacist. Only single doses of such preparations shall be removed from the container, and then only after the preparation has been prescribed for a specific patient, and the order has been duly recorded upon the records of the institution. This requirement shall not apply to nor be construed as preventing the administration of treatment in bona fide emergency cases, or further as prohibiting any person who is a duly licensed physician from dispensing medicinal drugs as defined in Chapter 465, F.S. A single dose of medicinal drugs based upon a valid physician’s drug order may also be obtained and administered under the supervision of the nurse in charge consistent with good institutional practice procedures as established by the consultant pharmacist of record and written in the policy and procedure manual which shall be available within the pharmacy.
(2) No change.
Rulemaking Specific Authority 465.005, 465.022 FS. Law Implemented 465.019(2)(b), 465.0196, 465.022(1) FS. History– Amended 5-19-72, Repromulgated 12-18-74, Amended 10-10-78, Formerly 21S-1.11, 21S-1.011, Amended 7-31-91, Formerly 21S-28.602, 61F10-28.602, Amended 9-4-96, Formerly 59X-28.602, Amended_________.
64B16-28.6021 Institutional Class II Pharmacy – Emergency Department Dispensing Class II Institutional Pharmacy – Emergency Department Dispensing.
(1) through (4) No change.
(5) Violations of this section:
(a) Violations of this section by the prescriber/dispenser shall be referred to the prescriber/dispenser’s regulatory board.
(b) Violations of this section by the Class II permit holder shall subject the permit holder to disciplinary action.
Rulemaking Specific Authority 465.005, 465.019(4), 465.022 FS. Law Implemented 465.022(1), 465.019(2)(b), 465.019(4), 465.0196 FS. History–New 9-20-99, Amended________.