20 CSR 2220-8.045 - Standards of Operation (Third-Party Logistics Providers)
(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 manager-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 manager-in-charge application must be submitted to the board with the
applicable fee within fifteen (15) calendar days after the new
manager-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 outsourcer.
(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.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.