§ 391.6. Storage, handling and recordkeeping
Purdon's Pennsylvania Statutes and Consolidated StatutesTitle 63 P.S. Professions and Occupations (State Licensed)
63 P.S. § 391.6
§ 391.6. Storage, handling and recordkeeping
(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(f) Returned, damaged and outdated prescription drugs.--Prescription drugs that are outdated, damaged, deteriorated, misbranded or adulterated shall be quarantined and physically separated from other prescription drugs until they are destroyed or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.
(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:
(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.
(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.
1992, Dec. 14, P.L. 1116, No. 145, § 6, imd. effective.
63 P.S. § 391.6, PA ST 63 P.S. § 391.6
Current through 2023 Regular Session Act 32. Some statute sections may be more current, see credits for details.
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