Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 5 - Drug Distributor › Section 20 CSR 2220-5.020 - Drug Distributor Licensing Requirements

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment would waive Missouri drug
				  distributor licensure requirements for entities shipping drugs or vaccines to
				  treat or immunize patients during a state or federally declared disaster or
				  emergency, or pursuant to an emergency use authorization issued by the United
				  States Food and Drug Administration for a public health
				  emergency.
(1) A "wholesale
				drug distributor" is defined in section
				338.330(3),
				RSMo. No wholesale drug distributor with physical facilities located in the
				state of Missouri shall knowingly purchase or receive legend drugs and/or drug
				related devices from a wholesale drug distributor or pharmacy not licensed or
				registered by the board. Knowledge of the licensure status of a drug
				distributor or pharmacy includes, but is not limited to, actual or constructive
				knowledge. Knowledge of the license status of a drug distributor or pharmacy
				shall also include, but not be limited to, notification from the board by mail
				or electronic transmission.
(A) A wholesale
				drug distributor is further defined as anyone engaged in wholesale distribution
				of prescription drugs, including, but not limited to, manufacturers; repackers;
				own-label distributors; private-label distributors; jobbers; brokers;
				warehouses, including manufacturers' and distributors' warehouses, chain drug
				warehouses and wholesale drug warehouses; independent wholesale drug traders;
				and retail pharmacies that conduct wholesale distributions.
(B) Licensure and/or registration as a
				wholesale drug distributer is not required for activities described below-
1. The sale, purchase, transfer, or trade of
				a drug or an offer to sell, purchase, transfer, or trade a drug for emergency
				administration to an individual patient if a delay in therapy would negatively
				affect a patient outcome. The amount sold, purchased, transferred, or traded
				shall not exceed five percent (5%) of the pharmacy's total gross prescription
				sales or, if prescriptions are not sold, five percent (5%) of the pharmacy's
				total drug purchases;
2. The sale,
				purchase, or trade of blood and blood components intended for transfusion and
				any other exemptions as provided for in Chapter 338, RSMo;
3. The sale, purchase, transfer, or trade of
				a drug or an offer to sell, purchase, or trade a drug by a Missouri licensed
				pharmacy that does not exceed five percent (5%) of the pharmacy's total gross
				sales. For purposes of this section, total gross sales shall be calculated
				based on the pharmacy's total annual prescription drug sales or, if
				prescriptions are not sold, five percent (5%) of the pharmacy's total drug
				purchases;
4. The sale, purchase,
				transfer, or trade of a drug or offer to sell, purchase, transfer, or trade a
				drug among hospitals or by a hospital to a healthcare entity under the same
				common control or ownership as the hospital. "Common control or ownership"
				means the power to direct or cause the direction of the management and policies
				of a person or an organization whether by ownership, stock, voting rights,
				contract, or otherwise. For purposes of this rule, a "hospital" shall be
				limited to a hospital as defined by Chapter 197, RSMo, or a hospital operated
				by the state;
5. The storage or
				distribution of drugs by a local, state, or federal facility that are received
				from the Strategic National Stockpile or the state stockpile for the purpose of
				providing those drugs in an emergency situation as authorized by a state or
				federal agency;
6. The sale,
				purchase, or transfer of a drug or vaccine received from or on behalf of a
				federal, state, or municipal entity for the purpose of treating or immunizing
				patients during a state or federally declared disaster or emergency;
7. The sale, purchase, or transfer of a drug
				or vaccine subject to an emergency use authorization issued by the United
				States Food and Drug Administration for a public health emergency;
8. The sale, purchase, transfer, or trade of
				a prescription drug to alleviate a temporary shortage of a prescription drug
				that is in limited supply or unavailable due to delays in or interruption of
				supply. Drugs sold, purchased, transferred, or traded pursuant to this section
				shall only be sold, purchased, transferred, or traded directly from an importer
				or manufacturer authorized by or registered with the United States Food and
				Drug Administration (FDA) to import or manufacture the drug that is unavailable
				or in short supply. In addition, sales, purchases, transfers, or trades shall
				be limited to the period of shortage and to the drug that is unavailable or in
				limited supply. Documentation of FDA authorization or registration shall be
				maintained in the licensee's or recipient's records; and
9. The sale, purchase, transfer, or trade of a drug
				between a Missouri licensed pharmacy and a non-resident pharmacy that is
				located in and licensed by another state or United States territory. The total
				amount of drug sold, purchased, transferred, or traded by the Missouri-licensed
				pharmacy pursuant to this subsection shall not exceed five percent (5%) of the
				pharmacy's total annual prescription drug sales. Missouri pharmacies receiving
				drugs pursuant to this section from a non-resident pharmacy shall maintain the
				following records for two (2) years from the date of sale, purchase, transfer,
				or trade:
A. Proof the non-resident pharmacy
				holds a current pharmacy license in the state or territory from which the drug
				is shipped or distributed; and
B.
				An invoice record which documents the name and address of the non-resident
				pharmacy, the date of sale, purchase, transfer, or trade, and the name,
				strength, and quantity of the drug received. The pharmacies shall also comply
				with all applicable controlled substance requirements.
(C) Wholesale drug distributors
				shall inform the board of their current FAX number, any change in FAX number,
				and/or the fact that the wholesale drug distributor does not have a working
				FAX. In the event a wholesale drug distributor notifies the board that the
				wholesale drug distributor does not have a working FAX, notification from the
				board will be made to the wholesale drug distributor by first class mail. For
				the purposes of this rule, such notification by mail shall be considered
				effective three (3) days after mailing and shall have the same effect as
				notification by FAX.
(D) Failure to
				receive notification from the board shall not be a defense to violations of
				section (1) of this rule when the wholesale drug distributor has failed to
				comply with the requirements of subsection (1)(C) of this
				rule.