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PENNSYLVANIA STATUTES
TITLE 63. PROFESSIONS AND OCCUPATIONS (STATE LICENSED)
CHAPTER 11A. WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS LICENSE ACT
Date:
08/31/2009
Document:
§ 391.6. Storage, handling and recordkeeping
(a) MINIMUM REQUIREMENTS.-- Licensees and their officers, agents, representatives and employees shall satisfy the minimum requirements of this section for the storage and handling of prescription drugs and for the establishment and maintenance of prescription drug distribution records.
(b) FACILITY.-- The facility 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outdated, damaged, deteriorated, misbranded or adulterated or that are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.
(4) Be maintained in a clean and orderly condition.
(5) Be free from infestation by insects, rodents, birds or vermin of
any kind.
(c) SECURITY.-- The facility shall be secure from unauthorized entry as follows:
(1) Access from outside the premises shall be kept to a minimum and be
well controlled.
(2) The outside perimeter of the premises shall be well lighted.
(3) Entry into areas where prescription drugs are held shall be limited
to authorized personnel.
(4) The facility shall be equipped with an alarm system to detect entry
after hours.
(5) The facility 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) 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 the United States Pharmacopeia/National Formulary (USP/NF). If no storage requirements are established for a prescription drug, the drug may be held at controlled room temperature, as defined in the USP/NF, to help ensure that its identity, strength, quality and purity are not adversely affected. Appropriate manual, electromechanical or electronic temperature and humidity recording equipment, devices or logs shall be utilized to document proper storage of prescription drugs. The recordkeeping requirements under subsection (g) shall be followed for all stored drugs.
(e) EXAMINATION OF MATERIALS.-- 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. 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. The recordkeeping requirements in subsection (g) shall be followed for all incoming and outgoing prescription drugs.
(f) RETURNED, DAMAGED AND OUTDATED PRESCRIPTION DRUGS.-- 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. 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 the conditions under which a prescription drug has been returned cast doubt on the drug's safety, identity, strength, quality or purity, 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 or 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 licensee 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. The recordkeeping requirements under subsection (g) shall be followed for all outdated, damaged, deteriorated, misbranded or adulterated prescription drugs.
(g) RECORDKEEPING.--
(1) The licensee 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.
(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 two years following disposition of the
drugs.
(3) Records described in this section that are kept at the facility 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
facility and not electronically retrievable shall be made available for
inspection within two working days of an authorized request by an
authorized official of a Federal, State or local law enforcement
agency.
(h) WRITTEN POLICIES AND PROCEDURES.-- The licensee 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. The licensee shall include in its 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 the deviation is temporary and appropriate.
(2) A procedure to be followed for handling recalls and withdrawals of
prescription drugs. The procedure shall be adequate to deal with
recalls and withdrawals due to any of the following:
(i) Any action initiated at the request of the department, the United
States Food and Drug Administration or other Federal, State or local
law enforcement or other government agency.
(ii) Any voluntary action by the manufacturer to remove defective or
potentially defective drugs from the market.
(iii) Any 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 the licensee prepares for, protects
against and handles any crisis that affects security or operation of
the facility in the event of strike, fire, flood or other natural
disaster or other situations of national, State or local 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 two years after disposition of the outdated
drugs.
(i) RESPONSIBLE PERSONS.-- The licensee shall:
(1) 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.
(2) Ensure that all personnel involved in the wholesale distribution of
prescription drugs have an adequate combination of education, training
and experience to perform their duties in a manner that ensures
compliance with this act and applicable regulations.
(j) SALVAGING AND REPROCESSING.-- The licensee shall comply with any applicable Federal, State or local law or regulation that relates to prescription drug salvaging or reprocessing.
(k) COMPLIANCE WITH FEDERAL, STATE AND LOCAL LAW.-- The licensee shall operate in compliance with applicable Federal, State and local laws and regulations. The licensee shall permit the department and authorized Federal, State and local law enforcement officials to enter and inspect its premises and delivery vehicles and to audit its records and written operating procedures, at reasonable times and in a reasonable manner, to the extent authorized by law. The licensee that deals in controlled substances shall register with the Drug Enforcement Administration (DEA) and shall comply with all applicable DEA, State and local regulations.
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