New Florida Rules Shorten Required Hours For Community Pharmacies and Change Start of Business Requirements
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
The Florida Board of Pharmacy (BOP) amended its rules regarding community pharmacies following a request for relief by industry health care professionals. The amended rules include shortening community pharmacy hours of operation from 40 to 20 hours per week, pharmacy delays to open business after the receipt of a permit and changes regarding ownership. Rules promulgated by The Florida BOP are published in the Florida Administrative Code (FAC).
Community Pharmacies May Delay Opening After Application is Approved.
The rule changes allow community pharmacies to delay the opening of business after receipt of the pharmacy permit. The BOP acknowledged that a delay may exist between the time a pharmacy receives a permit and when the pharmacy commences operations. For example, the delay in receiving the Drug Enforcement Administration (DEA) registration would make it difficult to structure an asset purchase. Ordinarily the pharmacy would have to obtain a new pharmacy permit and then obtain its DEA registration in an asset purchase transaction. Once the pharmacy permit has been received under prior rules, the pharmacy had to start operations (then 40 hours a week), but could not dispense controlled substances or obtain insurance contracts without the DEA registration.
Under the new rules, the BOP must be given notice (within 15 days) if the pharmacy is delaying its opening and give its reason. When it does open for business, the Board must be notified within two days. If the permittee delays commencement of operations, it must:
• Display a sign in block letters not less than one inch in height at the main entrance of the establishment stating that the pharmacy is not yet open for business and that medicinal drugs may not be dispensed or sold nor prescriptions filled or dispensed; and
• Within two business days of commencement of operations the permittee must notify the Board in writing that the permittee has commenced to operate and the date of such commencement.
Additionally, it is important to know that any pharmacy which does not commence operations within six months of the date of receipt of its permit, must provide a written statement to the Board that includes the reason(s) that the pharmacy has failed to commence operations, the efforts the pharmacy has made to commence to operate, the exact date the pharmacy expects to commence operations.
Changes in Ownership.
The BOP also amended the rules regarding changes of ownership and clarified that transfers of ownership in business entities (i.e., a corporation, limited liability company, limited partnership, etc.) holding pharmacy permits do not constitute “changes of ownership” when such entity continues to hold the permit without change in identity (purchase of stock or membership interests for example). Upon the transfer of ownership interests in the business entity, the following steps must also be taken:
• Within fifteen days of closing the transfer, the permittee must notify the BOP of the transfer of ownership; and
• All persons, members, partners, officers, directors, and agents having an ownership or other financial interest of greater than five percent and all persons who directly or indirectly manage, oversee, or control the operation of the business entity must file their fingerprints with the BOP.
The rule amendments, especially the reduction in community pharmacy operating hours from 40 per week to 20 per week, may give pharmacies the leeway for new opportunities and to try new business ventures, without incurring the expense of having to pay a full-time pharmacist.
Whether opening a new establishment, changing locations or changing owners, it is important to be aware of the licensing requirements and rules, process, fees and statutes.
A pharmacy permit is required prior to operating in the State of Florida. To learn about the changes and important information on obtaining a community pharmacy permit, click here to visit the Florida Board of Pharmacy.
To learn more on how we can help you or your practice if such a situation arises, click here to read one of my prior blogs.
Consult With A Health Law Attorney Experienced in the Representation of Pharmacists and Pharmacies.
We routinely provide deposition coverage to pharmacists, pharmacies and other health professionals being deposed in criminal cases, negligence cases, civil cases or disciplinary cases involving other health professionals.
The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians, physician assistants and other health professionals in investigations and at Board of Pharmacy hearings. Call now or visit our website www.TheHealthLawFirm.com.
Akerman LLP. “The Board of Pharmacy’s 40 Hour Rule is Dead! Long live the 20 Hour Rule! Community Pharmacy Ownership Rule Change Creates new Opportunities.” Lexology. (August 30, 2016). Web.
About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.
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