Chapter Phar 18

Phar 18.05(1)(b) (b) Has been employed full-time for at least three years in a pharmacy or with a wholesale prescription drug distributor in a capacity related to the dispensing of and distribution of, and recordkeeping related to, prescription drugs.

Phar 18.05(1)(c) (c) Is employed full-time in a managerial position.

Phar 18.05(1)(d) (d) Is physically present at the third-party logistics provider’s or out-of-state third-party logistics provider’s facility during regular business hours. This paragraph does not preclude the person from taking authorized sick leave and vacation time or from being absent from the facility for other authorized business or personal purposes.

Phar 18.05(1)(e) (e) Is actively involved in and aware of the daily operation of the third-party logistics provider or the out-of-state third-party logistics provider.

Phar 18.05(1)(f) (f) Is a designated representative for only one applicant at any given time. This paragraph does not apply if more than one third-party logistics provider or out-of-state third-party logistics provider is located at the facility and the third-party logistics provider or out-of-state third-party logistics providers located at the facility are members of an affiliated group.

Phar 18.05(1)(g) (g) Has not been convicted of violating any federal, state, or local law relating to distribution of a controlled substance.

Phar 18.05(1)(h) (h) Has not been convicted of a felony.

Phar 18.05(1)(i) (i) Submits to the department 2 fingerprint cards, each bearing a complete set of the person’s fingerprints. The department of justice shall provide for the submission of the fingerprint cards to the federal bureau of investigation for purposes of verifying the identity of the person and obtaining the person’s criminal arrest and conviction record.

Phar 18.05(2) (2) Officers, directors and managers. A third-party logistics provider or out-of-state third-party logistics provider licensed under this chapter shall maintain a list of officers, directors, and managers, including a description of their duties and a summary of their qualifications.

Phar 18.05 History History: CR 23-031: cr. Register June 2024 No. 822, eff. 7-1-24; correction in (1) (d), (f) made under s. 13.92 (4) (b) 7., Stats., Register June 2024 No. 822.

Phar 18.06 Phar 18.06 Facility and storage requirements. All facilities licensed as third-party logistics providers or out-of-state third-party logistics providers shall:

Phar 18.06(1) (1) Maintain access to warehouse space of suitable size to facilitate safe operations, including a suitable area to quarantine suspect product.

Phar 18.06(2) (2) Have written policies and procedures to:

Phar 18.06(2)(a) (a) Address receipt, security, storage, inventory, shipment, and distribution of a product.

Phar 18.06(2)(b) (b) Identify, record, and report confirmed losses or thefts.

Phar 18.06(2)(c) (c) Correct errors and inaccuracies in inventories.

Phar 18.06(2)(d) (d) Provide support for manufacturer recalls.

Phar 18.06(2)(e) (e) Prepare for, protect against, and address any reasonably foreseeable crisis that affects security or operation at the facility, such as a strike, fire, or flood.

Phar 18.06(2)(f) (f) Ensure that any expired product is segregated from other products and returned to the manufacturer or repackager or destroyed.

Phar 18.06(2)(g) (g) Maintain the capability to trace the receipt and outbound distribution of a product, and supplies and records of inventory.

Phar 18.06(2)(h) (h) Quarantine or destroy a suspect product if directed to do so by the respective manufacturer, wholesale distributor, dispenser, or an authorized government agency.

Phar 18.06 History History: CR 23-031: cr. Register June 2024 No. 822, eff. 7-1-24.

Phar 18.07 Phar 18.07 Security requirements. All facilities shall require the following:

Phar 18.07(1) (1) Access from outside the premises is kept to a minimum and is well controlled.

Phar 18.07(2) (2) The outside perimeter of the premises is well lighted.

Phar 18.07(3) (3) Entry into areas where prescription drugs are held is limited to authorized personnel.

Phar 18.07(4) (4) An alarm system is maintained to detect entry after hours.

Phar 18.07(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 18.07 History History: CR 23-031: cr. Register June 2024 No. 822, eff. 7-1-24.

Phar 18.08 Phar 18.08 Compliance. A third-party logistics provider or an out-of-state third-party logistics provider who elects to be licensed under this chapter and fails to comply with all applicable federal and state laws and regulations may be subject to disciplinary action by the board under s. 450.10, Stats.

Phar 18.08 History History: CR 23-031: cr. Register June 2024 No. 822, eff. 7-1-24.