Current through Register Vol. 49, No. 6, March 15, 2024
(1) Third-party logistics providers (3PL)
shall comply with all applicable state and federal law governing 3PL
activities, controlled substances and drug distribution/handling, including,
but not limited to, the federal Food, Drug and Cosmetics Act, as amended by the
federal Drug Supply Chain Security Act ( 20 USC section 351 et seq).
(2) Manager-In-Charge. No third-party
logistics provider license will be issued unless the facility is under the
direct supervision of a man-ager-in-charge who has been designated with the
board and who will be responsible for facility operations and ensuring
compliance with state and federal law. The designated manager-in-charge must
have appropriate education or experience to perform the duties assigned. At a
minimum, the manager-in-charge must have at least two (2) years of
education/experience in third-party logistics provider or drug distribution
standards of operation or legal/compliance requirements. Education beyond a
high school diploma or its equivalent may be used to meet these minimum
requirements.
(A) 3PL activities must be
conducted under the supervision of the designated manager-in-charge. The
manager-in-charge must be actively involved and aware of the daily operations
of the third-party logistics provider and must be physically present at the
third-party logistics provider facility during normal business hours, except
for absences due to illness, scheduled vacations, or other authorized absence.
The manager-in-charge must ensure that policies and procedures governing the
third-party logistics provider's operations are current and accurate.
(B) In the event the manager-in-charge
designated with the board changes, the third-party logistics provider may not
continue operations until a new manager-in-charge is named. A change of
manag-er-in-charge application must be submitted to the board with the
applicable fee within fifteen (15) calendar days after the new
manag-er-in-charge is designated.
(C) In addition to the manager-in-charge, all
individuals employed or engaged in third-party logistics operations must have
sufficient education, training, or experience to perform the duties assigned. A
list must be maintained of all managers or other individuals in charge of 3PL
activities or drug distribution, storage and handling, and a description of the
individual's duties.
(3)
Facility Standards. The following requirements are applicable to all 3PL
facilities:
(A) All state and federal 3PL,
controlled substance and drug distribution licenses or registrations must be
current and accurate. The facility's Missouri 3PL license must be conspicuously
posted at the 3PL facility licensed by the board;
(B) 3PL facilities must be of suitable size
and construction to allow proper cleaning, maintenance, and facility
operations. Appropriate sewage disposal and a hot and cold water supply must be
available. The outside perimeter of the premises must be well-lit;
and
(C) 3PL facilities must be
securely maintained at all times to prevent unauthorized access to the
facility, drugs, or drug storage areas. Additionally, 3PL facilities must be
equipped with a security system that will provide suitable protection against
theft and diversion, including, electronic theft or diversion. All facilities
must be equipped with an alarm system to detect entry after hours.
(4) Drug Storage and Distribution.
3PL activities must be safely and accurately performed at all times in
compliance with applicable state and federal law. Only drugs of appropriate
quality may be distributed. No counterfeit, outdated, misbranded, expired, or
adulterated drug may be distributed, sold, or brokered by or on behalf of a
3PL.
(A) Appropriate lighting, sanitation,
ventilation, and humidity must be maintained in all areas where drugs are
stored or distributed. Aisles, walkways, and shelves in drug storage areas must
be clear of debris, dirt, and filth. Dust must be kept at low levels through
adequate ventilation or proper cleaning procedures.
(B) Waste and hazardous materials must be
handled and disposed of in compliance with applicable state and federal
law.
(C) Drug storage areas must be
free from insects, vermin, and animals of any kind, except for service animals
as defined by the Americans with Disabilities Act (ADA).
(D) Drugs must be properly stored and
maintained in a thermostatically controlled area within temperature and
humidity requirements as provided in the FDA approved drug product labeling or
the United States Pharmacopeia (USP).
(E) Temperatures in drug storage areas must
be recorded and reviewed at least once each day the facility is in operation.
Alternatively, a continuous temperature monitoring system may be used if the
system maintains ongoing documentation of temperature recordings that alerts
the manager-in-charge or designated facility staff when temperatures are
outside of the required range.
(F)
3PLs located in this state may only purchase or receive legend drugs and/or
drug related devices from an entity licensed as a Missouri drug distributor,
third-party logistics provider, or drug out-sourcer.
(G) No outdated, misbranded, or adulterated
drugs or devices may be dispensed or maintained within the facility's active
inventory, including prescription and related nonprescription items. Outdated,
misbranded, or adulterated medication must be quarantined in a clearly
identified segregated area and maintained separately from drugs intended for
distribution or being processed for distribution.
(H) No third-party logistics provider 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, third-party logistics provider, drug outsourcer, or pharmacy not
licensed or registered by the board.
(I) Drugs held for distribution must be
stored in a secure area where only authorized personnel have access to them. A
list of all individuals who have independent access to drug storage areas must
be maintained. The list must be maintained for three (3) years and must be
readily retrievable on request of the board or the board's authorized
designee.
(J) Medication may not be
stored on the floor. Drug products must be raised above floor level and placed
on a pallet or similar device.
(K)
The outside shipping container of received medication must be visually examined
for identity and for container and content integrity to prevent the acceptance
or distribution of any contaminated, adulterated, or otherwise unfit
medication. Any prescription drug whose immediate or sealed outer container or
sealed secondary container has been opened, used, or improperly compromised
must be quarantined and physically separated from the facility's active
inventory.
(L) Drugs shipped for
distribution or further use must be carefully inspected prior to
shipping/distribution for identity and to ensure prescription drugs that have
been damaged in storage or held under improper conditions are not distributed.
Licensees shall maintain and follow security procedures for delivering drugs
from the facility to the destination site.
(M) Drug products must be labeled as required
by the manufacturer and state and federal law, including, section 338.059.2,
RSMo.
(N) Third-party logistics
providers must develop and implement written policies and procedures to ensure
the safe and appropriate delivery of prescription drugs within the temperature
requirements recommended by the manufacturer or the United States Pharmacopeia
(USP).
(O) For returned medication,
licensees must consider the conditions under which the medication has been
held, stored, or shipped, the condition of the drug and its container/carton
and any other relevant factor that may reflect on the drug's fitness for
further use or distribution. If the conditions under which a prescription drug
has been returned cast doubt on the drug's safety, identity, strength, quality,
or purity, then the drug must be destroyed or returned to the supplier, unless
examination, testing, or other investigation proves that the drug meets
appropriate standards of safety, identity, strength, quality, and
purity.
(P) Licensees shall file a
written or electronic report with the board within seventy-two (72) hours after
discovery of:
1. Any suspected criminal
activity related to or diversion of a prescription drug or device;
and
2. Any real or suspected
counterfeit, contraband, or illegitimate prescription drug or drug-related
device. The report must include the name of the drug, quantity, and lot
number(s). Recalls initiated by the Food and Drug Administration (FDA) or by a
supplier licensed with the state of Missouri do not have to be reported, unless
otherwise required by state and federal law.
(5) Policies and Procedures. 3PLs must
maintain and follow current and accurate policies and procedures governing all
aspects of the facility's 3PL activities. Policies and procedures must be
physically or electronically maintained at the facility, provided the
policies/procedures are immediately retrievable at the request of the board or
the board's authorized designee.
(6) Agents or employees of a licensed
third-party logistics provider may have legend drugs in their custody if they
are acting in the usual course of business or employment and their names and
addresses and the addresses of all sites where drugs are stored have been
provided to the board. Drugs stored and transported by agents or employees of a
third-party logistics provider must be maintained in accordance with
manufacturer or USP guidelines and must be free of contamination,
deterioration, or adulteration.
(7)
Record-Keeping. 3PL records must be accurately maintained in compliance with
state and federal law. Additionally, licensees must maintain inventories and
records of all transactions regarding the receipt, distribution, or other
disposition of prescription drugs or prescription drug-related devices.
(A) The following records must be maintained:
1. The date drugs or drug-related devices are
received or distributed;
2. The
identity and quantity of drugs or drug-related devices received, distributed,
or disposed of;
3. The identity of
any suppliers of prescription drugs or drug-related items, including the name
and principal address of the seller/transferor and the address of the location
where the drug/drug-related item was shipped from;
4. The name and address of any recipients of
prescription drugs or drug-related items; and
5. Any records required by state and federal
law.
(B) Unless otherwise
provided by law, records required by Chapter 338 or this rule must be
maintained for three (3) years. Records may be manually or electronically
maintained, provided the record is readily retrievable and available for
inspection, photographing, or duplication at the request of the board or the
board's authorized designee or at the request of authorized federal, state, or
local law enforcement officials. Records maintained offsite and not
electronically retrievable at the 3PL facility must be made available for
inspection within two (2) working days of a request by the board or an
authorized board designee.
(8) Exemptions. At its discretion, the board
may grant an exemption to the facility requirements of this rule for a time
period designated by the board if such exemption is not contrary to law and the
exemption will provide equal or greater protection of the public safety,
health, or welfare. Exemption requests must be submitted in writing and
identify the specific exemption requested, the grounds for exemption, the
requested exemption length, and proposed procedures or safeguards for
protecting the public safety, health, or welfare if the exemption is
approved.
