Wisconsin Legislature: Phar 13.14(1)(c)

History: Cr. Register, July, 1992, No. 439, eff. 8-1-92; EmR0815: emerg. am. (intro.) and (3), eff. 6-1-08; CR 08-051: am. (intro.) and (3) Register November 2008 No. 635, eff. 12-1-08.

Phar 13.10 Security requirements. All facilities shall require that:

(1) Access from outside the premises is kept to a minimum and be well controlled;

(2) The outside perimeter of the premises is well lighted;

(3) Entry into areas where prescription drugs are held is limited to authorized personnel;

(4) An alarm system is maintained to detect entry after hours; and

(5) A security system is maintained that will provide suitable protection against theft and diversion, including, when appropriate, a system that provides protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.

History: Cr. Register, July, 1992, No. 439, eff. 8-1-92; EmR0815: emerg. am. (3), eff. 6-1-08; CR 08-051: am. (3) Register November 2008 No. 635, eff. 12-1-08.

Phar 13.11 Storage requirements.

(1) All prescription drugs stored in a facility shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such products, or with requirements in the current edition of an official compendium.

(2) If no storage requirements are established for a prescription drug, the product may be held at a controlled room temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected.

(3) Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, or logs shall be utilized to document proper storage of prescription drugs.

(4) The recordkeeping requirements in s. Phar 13.14 shall be followed for all stored drugs.

History: Cr. Register, July, 1992, No. 439, eff. 8-1-92; EmR0815: emerg. am. eff. 6-1-08; CR 08-051: am. Register November 2008 No. 635, eff. 12-1-08.

Phar 13.12 Examination of materials requirements.

(1) Upon receipt by a facility, 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 from a facility shall be carefully inspected for identity of the prescription drug 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 s. Phar 13.14 shall be followed for all incoming and outgoing prescription drugs at a facility.

History: Cr. Register, July, 1992, No. 439, eff. 8-1-92; EmR0815: emerg. am. eff. 6-1-08; CR 08-051: am. Register November 2008 No. 635, eff. 12-1-08.

Phar 13.13 Returned, damaged and outdated prescription drug requirements.

(1) Prescription drugs in a facility 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 in a facility 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 to a facility cast doubt on the product’s safety, identity, strength, quality, or purity, then the product shall be destroyed, or returned to the supplier, unless examination, testing, or other investigation proves that the product meets appropriate standards of safety, identity, strength, quality, and purity. In determining whether the conditions under which a product has been returned cast doubt on its safety, identity, strength, quality, or purity, the distributor shall consider, among other things, the conditions under which the product has been held, stored, or shipped before or during its return and the condition of the product and its container, carton, or labeling, as a result of storage or shipping.

(4) The recordkeeping requirements in s. Phar 13.14 shall be followed for all outdated, damaged, deteriorated, misbranded, or adulterated prescription drugs.

History: Cr. Register, July, 1992, No. 439, eff. 8-1-92; EmR0815: emerg. am. eff. 6-1-08; CR 08-051: am. Register November 2008 No. 635, eff. 12-1-08.

Phar 13.14 Recordkeeping requirements.

(1) A distributor 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:

(a) 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:

(b) The identity and quantity of the drugs received and distributed or disposed of; and

(2) Inventories and records shall be made available for inspection and copying by the board, its authorized representatives, and authorized representatives of federal, state and local law enforcement agencies for a period of 3 years following distribution or other disposition of the drugs.

(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 the board or its authorized representative.

History: Cr. Register, July, 1992, No. 439, eff. 8-1-92; EmR0815: emerg. am. (1) and (2), eff. 6-1-08; CR 08-051: am. (1) and (2) Register November 2008 No. 635, eff. 12-1-08.

Phar 13.15 Written policies and procedures. A distributor 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. A distributor shall include in their written policies and procedures the following:

(1) A procedure to ensure that the oldest approved stock of a prescription drug 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:

(a) Any action initiated at the request of the food and drug administration or other federal, state, or local law enforcement or other governmental agency, including the board;

(b) Any voluntary action by the manufacturer to remove defective or potentially defective drugs from the market; or

(c) Any action undertaken to promote public health and safety by the replacing of existing merchandise with an improved product or new package design.

(3) A procedure to ensure that a distributor prepares for, protects against, and handles 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 are segregated from other products 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 3 years after disposition of the outdated drugs.

History: Cr. Register, July, 1992, No. 439, eff. 8-1-92; EmR0815: emerg. am. (intro.), (1), (2) (intro.), (b) and (4), eff. 6-1-08; CR 08-051: am. (intro.), (1), (2) (intro.), (b) and (4) Register November 2008 No. 635, eff. 12-1-08.

Phar 13.16 Responsible persons. A distributor shall establish and maintain lists of officers, directors, managers, and the designated representative in charge of wholesale drug distribution, storage, and handling, including a description of their duties and a summary of their qualifications.

History: Cr. Register, July, 1992, No. 439, eff. 8-1-92; EmR0815: emerg. am. eff. 6-1-08; CR 08-051: am. Register November 2008 No. 635, eff. 12-1-08.

Phar 13.17 Compliance with federal, state and local laws.

(1) A distributor shall operate in compliance with applicable federal, state, and local laws and regulations. A distributor shall operate in compliance with any applicable federal electronic track and trace pedigree system implemented after July 1, 2011, unless an earlier implementation date is mandated by federal law which explicitly preempts state law. A distributor that deals in controlled substances shall register with the drug enforcement administration.

(2) Failure to comply with applicable federal, state, and local laws and regulations constitutes unprofessional conduct for purposes of s. 450.10, Stats.

(3) A distributor shall permit the board or its authorized representatives 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. Such officials shall be required to show appropriate identification prior to being permitted access to a distributor’s premises and delivery vehicles.

History: Cr. Register, July, 1992, No. 439, eff. 8-1-92; EmR0815: emerg. am. (1), eff. 6-1-08; CR 08-051: am. (1) Register November 2008 No. 635, eff. 12-1-08.