Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-1 - REGULATIONS FOR DRUGS, DEVICES AND COSMETICS › Section 61N-1.015 - Licensing, Application, Permitting

Current through Reg. 50, No. 138; July 16, 2024
This section addresses the application and permitting
				  requirements of persons regulated under part I of chapter 499, F.S.
(1) Any person that is required under
				sections 499.001-.081, F.S., to have a permit shall apply to the department for
				the appropriate permit on forms indicated in this rule. Inquiries regarding
				requests for an application or licensing may be directed to The Department of
				Business and Professional Regulation, Drugs, Devices, and Cosmetics Program,
				2601 Blair Stone Road, Tallahassee, Florida 32399-1047 or telephone number
				(850)717-1800. Applications may be downloaded from the bureau's web site at
www.myfloridalicense.com
.
(2) A permit is valid only for the name and
				address to which it is issued. The name in which a permit is issued will be
				changed, at no cost, upon notification to the department.
(a) The name in which the permit is issued
				must be the name in which the company is doing business, i.e., the name that
				appears on purchase and sales invoices.
(b) A permit that authorizes the purchase of
				prescription drugs will not be issued in a name identical to the name used by
				any other establishment or licensed permit holder at that address authorized to
				purchase prescription drugs pursuant to chapter 465, F.S., or the statutes
				regulating a practitioner authorized to purchase prescription drugs except:
1. A Restricted Rx Drug Distributor -
				Charitable Organization permit will be issued in the name of the charitable
				organization or health care entity, and
2. A Medical Oxygen Retailer permit may be
				issued in the name of a nursing home's Class I Institutional Pharmacy
				permit.
(c) A person must
				be available for inspection at the permitted address during the business hours
				identified on the application form, holidays excluded. Permanent changes to
				these business hours must be communicated to the department in writing. At a
				minimum, these business hours must meet the following standards:
1. For an establishment applying for a permit
				or permitted as a prescription drug wholesaler or prescription drug wholesaler
				- broker only, the establishment must designate a minimum of 20 hours weekly
				between the hours of 8:00 a.m. and 5:00 p.m. (EST), Monday through Friday, and
				at least one day of the week provide for four consecutive hours.
2. For an establishment applying for a permit
				or permitted only as a medical oxygen retailer and which does not transfill
				medical oxygen containers at the permitted establishment, the establishment
				must designate a minimum of four (4) hours weekly between the hours of 8:00
				a.m. and 5:00 p.m. (EST), Monday through Friday, and at least one day of the
				week provide for two consecutive hours. Furthermore if less than 10 hours
				weekly are designated, a medical oxygen retailer must be available by telephone
				between the hours of 8:00 a.m. to 5:00 p.m., Monday through Friday, to schedule
				an appointment within 24 hours of the department's telephone call for an
				inspection during non-designated business hours.
3. Other applicants and permitted
				establishments must designate a minimum of 10 hours weekly between the hours of
				8:00 a.m. and 5:00 p.m. (EST), Monday through Friday, and at least one day of
				the week provide for two consecutive hours. These standards set forth minimum
				business hours and agents of the Department of Business and Professional
				Regulation and the Department of Law Enforcement may inspect, monitor, and
				investigate during other hours as authorized by
				law.