The Florida Board of Pharmacy (BOP) recently amended the rules regarding community pharmacy hours of operation to reduce required daily operating hours from 40 to 20 hours per week. As before, the hours have to be posted and the pharmacy must have a policy and procedure for transferring prescriptions and addressing emergency doses.
And, responding to a request for relief by the pharmacy industry, the rule changes allow community pharmacies to delay opening for 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, such as when there is a delay in obtaining the DEA registration. The delay in receiving the DEA registration made it difficult to structure the change of ownership arrangements as an asset purchase because the pharmacy had to obtain a new pharmacy permit and then get the DEA registration in an asset purchase transaction. Once the pharmacy permit was received, the pharmacy would have to start operations (and for 40 hours a week), but could not dispense controlled substances or obtain insurance contracts without the DEA registration. Accordingly, the amendment allows a permittee to notify the BOP in writing within 14 days of receipt of the permit of the permittee’s election to delay commencement while it waits for the DEA registration to issue (or for other reasons). The permittee must also include the reason for such delayed commencement. If the permittee does delay 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 2 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.
The amendment includes language, however, indicating that any pharmacy permittee that does not commence operations within 6 months of the date of receipt of its permit must provide a written statement to the BOP that includes the reasons that the pharmacy has failed to commence operations, the efforts the pharmacy has made to commence to operate, and the date the pharmacy expects to commence operations.
The BOP also amended the rules regarding changes of ownership (CHOWs) to clarify 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 manages, oversees, or controls the operation of the business entity must file with the BOP a set of fingerprints.
- A community pharmacy may obtain its permit, but delay opening the pharmacy for business while it obtains other necessary permits;
- The Board must be given notice (15 days) if the pharmacy is delaying its opening and once open, the Board must be notified within two days;
- If a pharmacy is located in Tallahassee, it is still “Commence to Operate” not “Fixing to Operate”;
- The reduction in community pharmacy operating hours from 40 per week to 20 per week may give pharmacies the opportunity to try new ventures, without the incurring the expense of the salary of a full-time pharmacist; and
- Pharmacies must provide the Board notice of a CHOW and conduct the necessary background checks.