[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR205.50]
[Page 114-117]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 205 GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG
Sec. 205.50 Minimum requirements for the storage and handling of
prescription drugs and for the establishment and maintenance of prescription
drug distribution records.
The State licensing law shall include the following minimum
requirements for the storage and handling of prescription drugs, and for
the establishment and maintenance of prescription drug distribution
records by wholesale drug distributors and their officers, agents,
representatives, and employees:
(a) Facilities. All facilities at which prescription drugs are
stored, warehoused, handled, held, offered, marketed, or displayed
shall:
(1) Be of suitable size and construction to facilitate cleaning,
maintenance, and proper operations;
(2) Have storage areas designed to provide adequate lighting,
ventilation, temperature, sanitation, humidity, space, equipment, and
security conditions;
(3) Have a quarantine area for storage of prescription drugs that
are outdated, damaged, deteriorated, misbranded, or adulterated, or that
are in immediate or sealed, secondary containers that have been opened;
[[Page 115]]
(4) Be maintained in a clean and orderly condition; and
(5) Be free from infestation by insects, rodents, birds, or vermin
of any kind.
(b) Security. (1) All facilities used for wholesale drug
distribution shall be secure from unauthorized entry.
(i) Access from outside the premises shall be kept to a minimum and
be well-controlled.
(ii) The outside perimeter of the premises shall be well-lighted.
(iii) Entry into areas where prescription drugs are held shall be
limited to authorized personnel.
(2) All facilities shall be equipped with an alarm system to detect
entry after hours.
(3) 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.
(c) Storage. All prescription drugs shall be stored at appropriate
temperatures and under appropriate conditions in accordance with
requirements, if any, in the labeling of such drugs, or with
requirements in the current edition of an official compendium, such as
the United States Pharmacopeia/National Formulary (USP/NF).
(1) If no storage requirements are established for a prescription
drug, the drug may be held at ``controlled'' room temperature, as
defined in an official compendium, to help ensure that its identity,
strength, quality, and purity are not adversely affected.
(2) Appropriate manual, electromechanical, or electronic temperature
and humidity recording equipment, devices, and/or logs shall be utilized
to document proper storage of prescription drugs.
(3) The recordkeeping requirements in paragraph (f) of this section
shall be followed for all stored drugs.
(d) Examination of materials. (1) Upon receipt, 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.
(2) 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.
(3) The recordkeeping requirements in paragraph (f) of this section
shall be followed for all incoming and outgoing prescription drugs.
(e) Returned, damaged, and outdated prescription drugs. (1)
Prescription drugs that are outdated, damaged, deteriorated, misbranded,
or adulterated shall be quarantined and physically separated from other
prescription drugs until they are destroyed or returned to their
supplier.
(2) 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.
(3) 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 safety, 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 wholesale 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.
(4) The recordkeeping requirements in paragraph (f) of this section
shall be followed for all outdated, damaged, deteriorated, misbranded,
or adulterated prescription drugs.
[[Page 116]]
(f) Recordkeeping. (1) Wholesale drug 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:
(i) 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;
(ii) The identity and quantity of the drugs received and distributed
or disposed of; and
(iii) The dates of receipt and distribution or other disposition of
the drugs.
(2) 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 3 years after the date of their
creation.
(3) 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 2 working days
of a request by an authorized official of a Federal, State, or local law
enforcement agency.
(g) Written policies and procedures. Wholesale drug 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.
Wholesale drug distributors shall include in their written policies and
procedures the following:
(1) A procedure whereby the oldest approved stock of a prescription
drug product is distributed first. The procedure may permit deviation
from this requirement, if such deviation is temporary and appropriate.
(2) A procedure to be followed for handling recalls and withdrawals
of prescription drugs. Such procedure shall be adequate to deal with
recalls and withdrawals due to:
(i) Any action initiated at the request of the Food and Drug
Administration or other Federal, State, or local law enforcement or
other government agency, including the State licensing agency;
(ii) Any voluntary action by the manufacturer to remove defective or
potentially defective drugs from the market; or
(iii) Any action undertaken to promote public health and safety by
replacing of existing merchandise with an improved product or new
package design.
(3) A procedure to ensure that wholesale drug distributors prepare
for, protect against, and handle any crisis that affects 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 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 2 years after disposition of the outdated drugs.
(h) Responsible persons. Wholesale 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.
(i) Compliance with Federal, State, and local law. Wholesale drug
distributors shall operate in compliance with applicable Federal, State,
and local laws and regulations.
(1) Wholesale drug distributors shall permit the State licensing
authority and authorized Federal, State, and local law enforcement
officials to enter and inspect their premises and delivery vehicles, and
to audit their records and written operating procedures, at reasonable
times and in a reasonable manner, to the extent authorized by law.
[[Page 117]]
(2) Wholesale drug distributors that deal in controlled substances
shall register with the appropriate State controlled substance authority
and with the Drug Enforcement Administration (DEA), and shall comply
with all applicable State, local, and DEA regulations.
(j) Salvaging and reprocessing. Wholesale 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 this chapter.
(Approved by the Office of Management and Budget under control number
0910-0251)
[55 FR 38023, Sept. 14, 1990, as amended at 64 FR 67763, Dec. 3, 1999]
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