Current through Register Vol. 49, No. 6, March 15, 2024
(1)
Drug distributors must maintain standards of practice that will ensure that
only drugs of appropriate quality will be distributed to practitioners for
further compounding and dispensing to the public. These standards shall be
subject to periodic reviews through the board's inspection process.
(A) This process will include on-site
inspections for drug distributors who are located in this state and may include
border states or by requesting information on licensure and inspections
conducted by other states or the federal government through the board
office.
(B) For purposes of this
rule, the term drug distributor, when used, defines anyone engaged in any
activity as defined in section
338.330,
RSMo.
(2) No drug
distributor license will be issued unless the facility is under the direct
supervision of a manager-in-charge.
(A) The
board shall consider the same factors in reviewing the qualifications of
someone who is appointed as a manager-in-charge as those outlined in
20 CSR
2220-5.020(8)(A) 1.
(B) A person must also have appropriate
education, experience, or both, before assuming the duties of
manager-in-charge. Appropriate education for purposes of this section is
defined as education in the areas of work environment, standards of operation
and knowledge of laws concerning drug distributor compliance and requirements.
1. Minimum requirements for
education/experience may be attained separately or in combination to total two
(2) years.
2. Experience within a
drug wholesale or pharmacy distributor facility or in any education endeavor
beyond a certificate of graduation from an accredited high school or its
equivalent may be utilized in meeting these minimum requirements.
(C) Any individual that is
considered a manager or supervisor within a facility but is not the
manager-in-charge of the facility must meet the minimum education/experience
requirements as set forth in this rule for a total of one (1) year.
(D) The licensee shall require all other
persons employed in any prescription drug wholesale distribution activity to
have education, training and experience, or any combination, sufficient for
that person to perform the assigned functions in a manner as to provide
assurance that the drug product quality, safety and security at all times will
be maintained as required by law.
(E) Drug distributor operations must be
conducted at all times under the supervision of a properly designated
manager-in-charge. The manager-in-charge must be actively involved and aware of
the actual daily operations of the drug distributor operation. The
manager-in-charge must be physically present at the drug distributor operation
during normal business hours, except for time periods when absent due to
illness, scheduled vacation or other authorized absence; and be aware of, and
knowledgeable about, all polices and procedures pertaining to the operations of
the drug distributor operation. When the person who is manager-in-charge
resigns or is terminated from the position, the holder of the license shall
immediately notify the board office of the resignation or termination of the
manager-in-charge and by notarized affidavit give the name of the new
manager-in-charge.
(3)
Minimum standards of practice for drug distributors shall include the
following:
(A) The facility must be of a
suitable size and construction to facilitate cleaning, maintenance and proper
operations;
(B) The temperature of
the facility where drugs are stored must be maintained thermostatically within
temperature requirements as provided for by the manufacturer or the latest
edition of the United States Pharmacopeia (USP). Appropriate
manual, electromechanical, or electronic temperature and humidity recording
equipment, devices, logs, or all of these, shall be utilized to document proper
storage of prescription drugs;
(C)
Appropriate housekeeping, sanitation, lighting, ventilation and humidity of all
areas where drugs are stored must be maintained.
1. All aisles and walkways must be free and
clear of debris, dirt or filth.
2.
Dust shall be kept at low levels through adequate ventilation, cleaning
procedures, or both.
3. All shelves
and storage areas shall be kept free of debris, dirt, dust and filth.
4. Full cases of drug products shall be
raised above floor level and placed on a pallet or similar device.
5. Upon receipt of legend drugs, each outside
shipping container shall be visually examined for identity and to prevent the
acceptance of contaminated prescription drugs or prescription drugs that are
otherwise unfit for distribution. This examination shall be adequate to reveal
container damage that would suggest possible contamination or other damage to
the contents.
6. Each outgoing
shipment shall be carefully inspected for identity of the prescription drug
products and to ensure that there is no delivery of prescription drugs that
have been damaged in storage or held under improper conditions.
7. Drugs stored in a facility or being
processed for distribution must be physically separated at all times from
articles, supplies or other drugs that are outdated, distressed, misbranded or
adulterated. An area separate from drug storage must be used to store
quarantined, nonusable substances or accumulated waste/garbage. Any
prescription drugs whose immediate or sealed outer or sealed secondary
containers have been opened or used shall be identified as such and shall be
quarantined and physically separated from other prescription drugs until they
are either destroyed or returned to the supplier. If a drug is received or
further distributed, either directly or through a secondary broker (paper)
transaction, that is wholly or in part found to be counterfeit, a report which
includes the name of the drug, quantity and lot number(s) must be forwarded to
the Board of Pharmacy within seven (7) days of gaining knowledge of the
transaction. Any recall of a product that is initiated by the Food and Drug
Administration (FDA) or by a vendor licensed with the state of Missouri shall
not be subject to the reporting requirement.
8. Flammable articles must be stored
separately and away from drug products held for later wholesale
distribution.
9. Drugs which may be
held for later distribution that are labeled for veterinary use must be stored
separately from those drugs that are to be distributed for human use.
10. Procedures must be in place to prevent,
control and alleviate infestation by insects, rodents, birds or vermin of any
kind. Animals, except for service animals as defined by the Americans with
Disabilities Act (ADA), are not allowed in the drug storage areas.
11. Appropriate sewage disposal and a hot and
cold water supply must be available.
12. The outside perimeter of the premises
shall be well-lighted.
13. All
facilities shall be equipped with an alarm system to detect entry after
hours.
14. All facilities shall be
equipped with a security system that will provide suitable protection against
theft and diversion. When appropriate, the security system shall provide
protection against theft or diversion that is facilitated or hidden by
tampering with computers or electronic records;
(D) The drug distributor license issued to
the facility must be displayed in a public area;
(E) Adequate refrigeration must be available
to ensure enough storage space for drugs requiring refrigeration or freezing
and under temperatures adequate to maintain the drug products as recommended by
the manufacturer, the latest edition of the USP, or both;
(F) The labeling of drug products held for
wholesale distribution must conform to requirements as set forth by the
manufacturer, FDA, the USP and section 338.059.2, RSMo;
(G) 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 shall be destroyed or returned to
the supplier, unless examination, testing or other investigation proves that
the drug meets appropriate standards of safe-t y, identity, strength, quality
and purity. In determining whether the conditions under which a drug has been
returned cast doubt on the drug's safety, identity, strength, quality or
purity, the drug distributor shall consider, among other things, the conditions
under which the drug has been held, stored or shipped before or during its
return and the condition of the drug and its container, carton or labeling, as
a result of storage or shipping;
(H) Drugs held for wholesale distribution
must be stored in a secure area where only authorized personnel have access to
them. Sufficient locking mechanisms must be in place and a list of personnel
who possess keys or passes which allow them to have independent access to any
part of a facility which stores drugs held for later distribution or where any
controlled substances are stored must be maintained. Records on all past
employees who have had access to drug storage or processing areas must be
maintained for a period of three (3) years;
(I) Wholesale drug and pharmacy distributors
shall establish and maintain inventories and records of all transactions
regarding the receipt and distribution or other disposition of prescription
drugs. These records shall include the following information:
1. The source of the drugs, including the
name and principal address of the seller or transferor and the address of the
location from which the drugs were shipped;
2. The identity and quantity of the drugs
received and distributed or disposed of; and
3. The dates of receipt and distribution or
other disposition of the drugs;
(J) Inventories and records shall be made
available for inspection and photocopying by authorized federal, state or local
law enforcement agency officials for a period of three (3) years following
disposition of the drugs;
(K)
Records described in this section that are kept at the inspection site or that
can be immediately retrieved by computer or other electronic means shall be
readily available for authorized inspection during the retention period.
Records kept at a central location apart from the inspection site and not
electronically retrievable shall be made available for inspection within two
(2) working days of a request by the board or its representatives;
(L) Record requirements as described in this
rule shall be followed for appropriate accountability and disposition for all
outdated, damaged, deteriorated, misbranded or adulterated prescription
drugs;
(M) Wholesale drug and
pharmacy distributors shall establish, maintain and adhere to written policies
and procedures, which shall be followed for the receipt, security, storage,
inventory and distribution of prescription drugs, including policies and
procedures for identifying, recording and reporting losses or thefts and for
correcting all errors and inaccuracies in inventories. Drug distributors shall
include in their written policies and procedures the following:
1. A procedure where the oldest approved
stock of a prescription drug product is distributed first. The procedure may
permit deviation from this requirement if the deviation is temporary and
appropriate;
2. A procedure to be
followed for handling recalls and withdrawals of prescription drugs. This
procedure shall be adequate to deal with recalls and withdrawals due to any-
A. Action initiated at the request of the FDA
or other federal, state, or local law enforcement or other government agency,
including the Board of Pharmacy;
B.
Voluntary action by the manufacturer to remove defective or potentially
defective drugs from the market; or
C. Action undertaken to promote public health
and safety by replacing existing merchandise with an improved product or new
package design;
3. A
procedure to ensure that drug distributors prepare for, protect against and
handle any crisis that affects the security or operation of any facility in the
event of strike, fire, flood or other natural disaster, or other situations of
local, state or national emergency;
4. A procedure for reporting counterfeit or
suspected counterfeit drugs or devices or counterfeiting or suspected
counterfeiting activities to the board;
5. A procedure for the mandatory reporting to
the board and any other appropriate federal or state agency of all shortages of
prescription drugs and devices where it is known or suspected that diversion or
theft is occurring;
6. A procedure
for investigating discrepancies involving counterfeit, suspect of being
counterfeit, contraband, or suspect of being contraband in the inventory and
reporting such discrepancies within seven (7) business days to the board and
any other appropriate federal or state agency shall be maintained by each drug
distributor;
7. A procedure for
reporting criminal or suspected criminal activities involving the inventory of
drug(s) and device(s) to the board within the seven (7) business days;
and
8. A procedure to ensure that
any outdated prescription drugs shall be segregated from other drugs and either
returned to the manufacturer or destroyed. This procedure shall provide for
written documentation of the disposition of outdated prescription drugs. This
documentation shall be maintained for three (3) years after disposition of the
outdated drugs.
(N) Drug
distributors will be responsible for security procedures for the delivery of
drugs from the wholesale facility to the destination site of all drug
shipments; and
(O) No drug
distributor license shall be issued to any location, regardless of zoning, that
is a residence or that shares an address and/or physical space with a business
not related to the distribution of prescription drugs or drug-related devices,
or not licensed and regulated by the state of Missouri.
(4) In addition to standards listed in this
rule for drug distributors, drug repackagers must observe federal standards
for-
(A) Packaging;
(B) Record keeping;
(C) Expiration dating;
(D) Plant facilities;
(E) Equipment;
(F) Personnel;
(G) Production and control
procedures;
(H)
Containers;
(I) Testing;
and
(J) Federal registration
requirements.
(5) Agents
or employees of licensed or registered drug distributors 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.
(A) Storage and transport of drugs by agents
or employees of drug distributors must be maintained in accordance with
manufacturer or USP guidelines and must be free of contamination, deterioration
or adulteration.
(B) Drug
distributors shall report to the board any agents or employees that are
registered pursuant to this section of this rule for any convictions for
violations of state or federal drug laws.
(6) Drug distributors shall establish and
maintain lists of officers, directors, managers and other persons in charge of
wholesale drug distribution, storage and handling, including a description of
their duties and a summary of their qualifications.
(7) Drug distributors shall be subject to the
provisions of any applicable federal, state or local laws or regulations that
relate to prescription drug product salvaging or reprocessing, including Parts
207, 210 and 211 of the Federal Food, Drug and Cosmetic Act.
*Original authority: 338.333, RSMo 1989; 338.343, RSMo
1989, amended 1993; and 338.350, RSMo 1989, amended 1993,
1995.