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-1.011 - Wholesale Distribution of Prescription Drugs - Exceptions and Specific Distributions Authorized

Current through Reg. 50, No. 138; July 16, 2024
(1) The exemption
				from the definition of wholesale distribution in Section 499.003(48)(b)2.,
				F.S., for "emergency medical reasons" includes:
(a) Transfers of a prescription drug between
				health care entities or from a health care entity to a retail pharmacy to
				alleviate a temporary shortage of a prescription drug arising from delays in or
				interruption of regular distribution schedules, and should not occur between
				the parties so as to amount to the health care entity regularly and
				systematically supplying that drug;
(b) Transfers of prescription drugs by a
				health care entity to an emergency transport vehicle which is under the
				direction of a medical director of an emergency medical service provider
				licensed under Chapter 401, F.S., for use in the treatment of persons
				transported to that health care entity to immediately restock a licensed
				vehicle or an emergency medical kit for prescription drugs used on that person
				or to immediately restock prescription drugs on the vehicle which have become
				unsuitable for use. This exception does not extend to the stocking of supply
				inventory or for warehousing of prescription drugs used by emergency medical
				service providers;
(c) Emergency
				transfers of prescription drugs as authorized in Rule
				59A-4.112, F.A.C., for nursing
				homes or Rule 64B16-28.6021, F.A.C., of the
				Florida Board of Pharmacy; or
(d)
				Transfers of prescription drugs by a retail pharmacy to another retail pharmacy
				or to a health care entity to alleviate a temporary shortage, but not for the
				regular and systematic supplying of that prescription drug;
(e) Transfers of prescription drugs in an
				emergency declared pursuant to Section
				252.36, F.S., until the state of
				emergency is lifted, under the following conditions:
1. The manufacturer, wholesaler, or other
				person supplying the prescription drugs is authorized by Florida law to
				distribute prescription drugs in or into Florida; and either:
a. The prescription drugs are delivered to a
				temporary emergency medical station, officially designated by the state
				emergency operation center as a Disaster Medical Assistance Team or State
				Medical Response Team site; or
b.
				The prescription drugs are delivered to a Pharmacy licensed under Chapter 465,
				F.S.;
2. The prescription
				drugs are transferred by a prescription drug wholesale distributor located
				outside of this state and not permitted by the Department on behalf of a
				prescription drug wholesale distributor located in the State of Florida for the
				purposes of supplying prescription drugs to authorized customers located in
				Florida, if the out-of-state prescription drug wholesale distributor meets the
				following conditions:
a. The out-of-state
				prescription drug wholesale distributor holds a current and active license as a
				wholesale distributor in its resident state, or is currently licensed as a
				prescription drug wholesale distributor pursuant to the federal act;
				and
b. The Florida prescription
				drug wholesale distributor holds a current and active prescription drug
				wholesale distributor permit with the Department; and
c. Both the in-state and out-of-state
				prescription drug wholesale distributors are under common ownership. For the
				purposes of this subsection, "common ownership" means that one prescription
				drug wholesale distributor owns the other prescription drug wholesale
				distributor or both prescription drug wholesale distributors share a common
				owner or ultimate parent company that has the authority to control the
				management and operations of both entities; and
d. The permitted Florida prescription drug
				wholesale distributor shall be responsible for ensuring the activities of the
				out-of-state prescription drug wholesale distributor conducted in Florida on
				its behalf during the state of emergency are in compliance with applicable
				Florida and federal requirements; and
e. The distributions of prescription drugs
				pursuant to this section shall terminate no more than thirty (30) days after
				the expiration of the state of emergency.
(f) Transfers of prescription drugs from a
				health care entity to a pharmacy or other end-user practitioner for a named
				patient to treat or prevent a serious medical condition when a shortage of the
				product is documented by the manufacturer;
but does not include regular and systematic sales of
				  prescription drugs to licensed practitioners that will be used for routine
				  office procedures.
(g)
				Transfers of prescription drugs by or on behalf of the Department of Health to
				the medical director of an advanced life support service provider, licensed
				under Chapter 401, Part III, F.S., and for further distribution to an emergency
				transport vehicle operated by the advanced life support services provider, for
				use in the treatment of persons in need of emergency medical
				services;
(h) Transfers of
				prescription drugs by or on behalf of the Department of Health to a health care
				entity authorized to purchase prescription drugs, for storage and use in the
				treatment of persons in need of emergency medical services, including
				controlling communicable diseases or providing protection from unsafe
				conditions that pose an imminent threat to public health;
(i) Transfers of prescription drugs by or on
				behalf of the Department of Health to the licensed medical director of a
				government agency health care entity, authorized to purchase prescription
				drugs, for storage and use in the treatment of persons in need of emergency
				medical services, including controlling communicable diseases or providing
				protection from unsafe conditions that pose an imminent threat to public
				health.
(j) Transfers of
				prescription drugs by or on behalf of the Department of Health to a community
				pharmacy authorized to purchase prescription drugs, for dispensing to persons
				in need of emergency medical services, including controlling communicable
				diseases or providing protection from unsafe conditions that pose an imminent
				threat to public health.