Licensure of Institutional Pharmacies

Pharmacy – Florida Statutes Chapter 465

General Requirements, Permits – Florida Administrative Code Chapter 64B16-28

Florida Board of Pharmacy

Institutional Pharmacy Permit Application and Information


The regulations regarding the destruction of controlled substances changed in 1996. A surgery center can contract with a D.E.A. approved company for the pick up and destruction of the controlled substances.

When a health care institution has secured an institutional pharmacy permit from the state, medicinal drugs can be stocked, stored, compounded, dispensed or administered (Florida Statutes, 465.019).

“Modified Class II Institutional Pharmacies” are those in short‑term, “rapid in/out surgical centers,” and primary care treatment centers that meet all the requirements for Class II permit, except space and equipment requirements. All institutional pharmacies must be under the professional supervision of a certified consultant pharmacist.

The consultant pharmacist must approve the policy and procedures regarding the handling, storing, and ordering of drugs and must provide monthly on‑site visits to ensure standards of practice are maintained. Required contents of the manual can be found in Florida Administrative Code, Chapter 59X‑28.702(6). The pharmacy policy and procedure manual no longer must accompany the permit application; however, answers to questions about specific policies and procedures must be provided.

Modified Class II Institutional Pharmacies must have:

·        A pharmacy services committee which meets at least annually;

·        A diagram of the facility and the security and storage of drugs.

and provisions for:

·        Handling of the emergency box;

·        Ordering, storing, and record keeping;

·        Medication Administration Record and/or perpetual inventory system for all controlled substances; and

·        Maintaining consultants’ records for two years.

An on‑site inspection of the facility and the intended security and storage of drugs is required before a permit is issued. This means the double lock narcotic cabinet and any other security and storage equipment must be in place for the inspection.

Submit the application at least six weeks before you are ready for an inspection.