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.
(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.