Current through Register Vol. 49, No. 6, March 15, 2024
PURPOSE: This rule provides standards of operation
for drug outsourcers licensed by the board.
(1) Drug outsourcers shall comply with all
applicable state and federal laws governing drug outsourcing activities,
including, but not limited to, controlled substance laws and the federal Food,
Drug and Cosmetics Act, as amended by the Drug Quality and Security Act.
(A) Except as otherwise required by federal
law, drug outsourcers must comply with all applicable current good
manufacturing practices (cGMPs) required by federal law and the United States
Food and Drug Administration.
(B) A
separate Missouri drug distributor license is required if a drug outsourcer is
engaged in any additional drug distribution activities as defined by Chapter
338, RSMo, other than drug outsourcing. A pharmacy license is required if
medication will be dispensed pursuant to a patient-specific
prescription.
(2) No
drug outsourcer license will be issued unless the facility is under the direct
supervision of a licensed pharmacist who has been designated with the board and
who will be responsible for facility operations and ensuring compliance with
state and federal law. For drug outsourcers located in Missouri, the pharmacist
must hold a current and active Missouri pharmacist license. For non-resident
drug outsourcers, the pharmacist must hold a current and active pharmacist
license issued by Missouri or another U.S. state/territory.
(A) Drug outsourcing activities must be
conducted at all times under the supervision of the designated pharmacist. The
pharmacist must be actively involved in and aware of the daily operations of
the outsourcing facility and must ensure that policies and procedures governing
drug outsourcing operations are current and accurate.
(B) In the event the pharmacist designated
with the board to supervise the facility changes, the drug outsourcer may not
continue operations until a new pharmacist is named to supervise the facility.
A change of pharmacist application must be submitted to the board with the
applicable fee within fifteen (15) calendar days after a new pharmacist is
designated to supervise.
(3) Sterile compounding and drug outsourcing
activities must be safely and accurately performed at all times to ensure that
only drugs of appropriate quality are distributed. No counterfeit, misbranded,
expired, or adulterated drug may be compounded, distributed, sold, or brokered
by or on behalf of a drug outsourcer.
(A) All
individuals employed or engaged in sterile compounding or drug outsourcer
activities must have sufficient education, training, or experience to perform
the duties assigned. A list must be maintained of all individuals engaged in
sterile compounding or in drug outsourcer activities with a description of the
individual's duties.
(B) Drug
outsourcers 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, drug outsourcer, or
pharmacy.
(C) Medication 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.
(D)
The outside shipping container of received medication and product ingredients
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 or drug ingredient 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.
(E) Medication shipped for distribution or
further use must be carefully inspected prior to shipping/distribution for
identity and to ensure no contaminated, adulterated, or misbranded drug or
compounded preparation is distributed. Licensees shall maintain and follow
security procedures for delivering drugs and compounded preparations from the
facility to the destination site.
(F) Drug outsourcers 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).
(G) For returned medication, licensees must
consider the conditions under which the drug 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 medication 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.
(H) Drug products must be labeled as required
by the manufacturer and state and federal law, including, section 338.059.2,
RSMo.
(4) Facility
Standards. The following standards are applicable to all drug outsourcing
facilities:
(A) Drug outsourcing facilities
must be securely maintained at all times to prevent unauthorized access to the
facility, drugs, or drug storage areas. Additionally, the facility 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 unauthorized entry after
hours.
(B) Appropriate sewage
disposal and a hot and cold water supply must be available.
(C) Waste and hazardous materials must be
handled and disposed of in compliance with applicable state and federal
law.
(D) Drug outsourcing
facilities must be free from insects, vermin, and animals of any kind, except
for service animals as defined by the Americans with Disabilities Act
(ADA).
(E) Medication 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).
(F) 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 pharmacist designated with the board for supervising the facility or alerts
designated facility staff when temperatures are outside of the required
range.
(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 compounding.
(H) Medication may not be stored on the
floor. Drug products must be raised above floor level and placed on a pallet or
similar device.
(I) Drug
outsourcers must report any recall of medication or a sterile preparation that
is, or suspected to be, misbranded, adulterated, or non-sterile. Recalls must
be reported to the board in writing within seven (7) days of a
recall.
(5) Policies and
Procedures. Drug outsourcers must maintain and follow current and accurate
policies and procedures governing all aspects of the facility's drug
outsourcing activities. Policies and procedures may 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) Record-Keeping. Drug
outsourcer 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, compounding, or other
disposition of prescription drugs or sterile preparations. 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 authorized designee or at the request of authorized federal, state, or
local law enforcement officials. Records maintained offsite and not
electronically retrievable at the drug outsourcer facility must be made
available for inspection within two (2) working days of a request by the board
or an authorized board designee.
