Phar 13.06 History History: Cr. Register, July, 1992, No. 439, eff. 8-1-92; EmR0815: emerg. r. (3), eff. 6-1-08; CR 08-051: r. (3) Register November 2008 No. 635, eff. 12-1-08.

Phar 13.07 Phar 13.07 Application review. The board shall act upon an application for a license within 60 business days after receiving the completed application, as provided in s. SPS 4.03. If the license is denied, the applicant may request a hearing pursuant to ch. SPS 1.

Phar 13.07 History History: Cr. Register, July, 1992, No. 439, eff. 8-1-92; am., Register, December, 1998, No. 516, eff. 1-1-99; correction made under s. 13.92 (4) (b) 7., Stats., Register November 2011 No. 671.

Phar 13.08 Phar 13.08 Personnel. A distributor shall employ adequate personnel with the education and experience necessary to safely and lawfully engage in the wholesale distribution of drugs.

Phar 13.08 History 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 13.09 Phar 13.09 Facility requirements. All facilities at which prescription drugs are stored, warehoused, handled, held, offered, marketed, or displayed shall:

Phar 13.09(1) (1) Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;

Phar 13.09(2) (2) Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;

Phar 13.09(3) (3) Have a quarantine area for storage of prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed secondary containers that have been opened;

Phar 13.09(4) (4) Be maintained in a clean and orderly condition; and

Phar 13.09(5) (5) Be free from infestation by insects, rodents, birds, or vermin of any kind.

Phar 13.09 History 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 Phar 13.10 Security requirements. All facilities shall require that:

Phar 13.10(1) (1) Access from outside the premises is kept to a minimum and be well controlled;

Phar 13.10(2) (2) The outside perimeter of the premises is well lighted;

Phar 13.10(3) (3) Entry into areas where prescription drugs are held is limited to authorized personnel;

Phar 13.10(4) (4) An alarm system is maintained to detect entry after hours; and

Phar 13.10(5) (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.

Phar 13.10 History 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 Phar 13.11 Storage requirements.

Phar 13.11(1) (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.

Phar 13.11(2) (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.

Phar 13.11(3) (3) Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, or logs shall be utilized to document proper storage of prescription drugs.

Phar 13.11(4) (4) The recordkeeping requirements in s. Phar 13.14 shall be followed for all stored drugs.

Phar 13.11 History 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 Phar 13.12 Examination of materials requirements.

Phar 13.12(1) (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.

Phar 13.12(2) (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.

Phar 13.12(3) (3) The recordkeeping requirements in s. Phar 13.14 shall be followed for all incoming and outgoing prescription drugs at a facility.