Phar 13.10   Security requirements.
Phar 13.11   Storage requirements.
Phar 13.12   Examination of materials requirements.
Phar 13.13   Returned, damaged and outdated prescription drug requirements.
Phar 13.14   Recordkeeping requirements.
Phar 13.15   Written policies and procedures.
Phar 13.16   Responsible persons.
Phar 13.17   Compliance with federal, state and local laws.
Ch. Phar 13 NoteNote: Chapter Phar 13 as it existed on July 31, 1992 was repealed and a new chapter Phar 13 was created effective August 1, 1992.
Phar 13.01Phar 13.01Authority. The rules in this chapter are adopted under authority in ss. 15.08 (5) (b), 227.11 (2) (a), 450.02 (3) (a) and 450.07 (4), Stats.
Phar 13.01 HistoryHistory: Cr. Register, July, 1992, No. 439, eff. 8-1-92.
Phar 13.02Phar 13.02Definitions. In this chapter:
Phar 13.02(1)(1)“Blood” means whole blood collected from a single donor and processed either for transfusion or further manufacturing.
Phar 13.02(2)(2)“Blood component” means that part of blood separated by physical or mechanical means.
Phar 13.02(3)(3)“Controlled substance” has the meaning set forth in s. 961.01 (4), Stats.
Phar 13.02(3m)(3m)“Department” means the department of safety and professional services.
Phar 13.02(4)(4)“Device” has the meaning set forth in s. 450.01 (6), Stats.
Phar 13.02(5)(5)“Distribute” has the meaning set forth in s. 450.01 (8), Stats.
Phar 13.02(7)(7)“Drug sample” means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.
Phar 13.02(8)(8)“Facility” means a location where a wholesale distributor stores, handles, repackages, or offers for sale prescription drugs.
Phar 13.02(9)(9)“Manufacturer” means a person licensed or approved by the federal food and drug administration to engage in the manufacture of drugs or devices, consistent with the definition of “manufacturer” under the federal food and drug administration’s regulations and interpreted guidance implementing the federal prescription drug marketing act.
Phar 13.02(10)(10)“Prescription drug” has the meaning set forth in s. 450.01 (20), Stats.
Phar 13.02(11)(11)“Wholesale distribution” means distribution of a prescription drug to a person other than a consumer or patient, but does not include any of the following:
Phar 13.02(11)(a)(a) Intracompany sales of prescription drugs which include any transaction or transfer between any division, subsidiary, parent, affiliated or related company under common ownership or control of a corporate entity or any transaction between co-licensees or a co-licensed product.
Phar 13.02(11)(b)(b) The sale, purchase, distribution, trade, or transfer of a prescription drug or offer to sell, purchase, distribute, trade, or transfer a prescription drug for emergency medical reasons.
Phar 13.02(11)(c)(c) The distribution of prescription drug samples, if the distribution is permitted under 21 CFR 353 (d).
Phar 13.02(11)(d)(d) Drug returns, when conducted by a hospital, health care entity, or charitable institution as provided in 21 CFR 203.23.
Phar 13.02(11)(e)(e) Distributions to a practitioner for the purpose of general dispensing by the practitioner to his or her patients if all of the following apply: