< FOA Legal Corner

Health Care Clinic Establishment Permit

During its 2008 Session, the Florida Legislature amended section 499.01, Florida Statutes, governing the various permits issued by the Florida Department of Health. The amendment to section 499.01 creates a health care clinic establishment permit, effective January 1, 2009.

A health care clinic establishment permit must be secured for the purchase of a prescription drug that is to be dispensed or administered at the practice establishment when the place of business is owned and operated by a professional corporation (“P.A.”) or a professional limited liability company. The permit application requires the establishment to designate the optometrist who will be responsible for complying with all legal and regulatory requirements related to the purchase, recordkeeping, storage, and handling of the prescription drugs. The optometrist designated on the application by the establishment must be the practitioner whose name, establishment address, and license number is used on all distribution documents (i.e., invoices, shipping, etc.) for prescription drugs purchased or returned by the health care clinic establishment.

A violation of this permit requirement is not only subject to remedies and penalties in Chapter 499, Florida Statutes, but constitutes a ground for discipline by the Board of Optometry. Furthermore, a county or municipality may not issue an occupational license for any establishment unless the establishment exhibits a current health care clinic establishment permit.

The Department of Health is in the process of implementing the new permit requirement. Several questions have been raised about the new permit. One question that has arisen is whether it is necessary for an optometrist who practices alone, but is incorporated as a P.A., to obtain a health care clinic establishment permit when purchasing a prescription drug to be dispensed or administered in the optometrist’s practice. The Department has indicated that a health care clinic establishment permit would not be required of that optometrist if he/she purchases the prescription drugs under his/her personal optometry license. If the optometrist personally is purchasing the prescription drugs only through the use of his/her personal optometry license number, a permit need not be obtained. However, any attempt to purchase the prescription drugs in the name of the optometrist’s P.A., and not through the use of his/her personal optometry license number, will require a health care clinic establishment permit.

Optometrists are encouraged to visit for Department of Health’s website for more information and to download the permit application.