Chapter Phar 13

Phar 13.09   Facility requirements.

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Phar 13.13   Returned, damaged and outdated prescription drug requirements.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 Phar 13 Note Note: Chapter Phar 13 as it existed on July 31, 1992 was repealed and a new chapter Phar 13 was created effective August 1, 1992.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 13.01 Phar 13.01 Authority. 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 History History: Cr. Register, July, 1992, No. 439, eff. 8-1-92.

Phar 13.02 Phar 13.02 Definitions. 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:

Phar 13.02(11)(e)1. 1. The total number of dosage units of all prescription drugs distributed to practitioners by the pharmacy during each calendar year in which the pharmacy is licensed does not exceed 5% of the total number of dosage units of all prescription drugs distributed and dispensed by the pharmacy during the same calendar year.

Phar 13.02(11)(e)2. 2. The total number of dosage units of all controlled substances distributed to practitioners by the pharmacy during each calendar year in which the pharmacy is licensed does not exceed 5% of the total number of dosage units of all controlled substances distributed and dispensed by the pharmacy during the same calendar year.

Phar 13.02(11)(f) (f) The sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug pursuant to a prescription.

Phar 13.02(11)(g) (g) The sale, transfer, merger, or consolidation of all or part of the business of a pharmacy from or with another pharmacy, whether accomplished as a purchase and sale of stock or business assets.

Phar 13.02(11)(h) (h) The sale, purchase, distribution, trade, or transfer of a prescription drug from one authorized distributor of record to one additional authorized distributor of record, if the manufacturer states in writing to the receiving authorized distributor of record that the manufacturer is unable to supply the drug and the supplying authorized distributor of record states in writing that the drug has previously been exclusively in the normal distribution channel.

Phar 13.02(11)(i) (i) The delivery of, or offer to deliver, a prescription drug by a common carrier solely in the common carrier’s usual course of business of transporting prescription drugs, if the common carrier does not store, warehouse, or take legal ownership of the drug.

Phar 13.02(11)(j) (j) A transaction excluded from the definition of “wholesale distribution” under 21 CFR 203.3 (cc).

Phar 13.02(11)(k) (k) The donation or distribution of a prescription drug under s. 255.056, Stats.

Phar 13.02(11)(L) (L) The transfer from a retail pharmacy or pharmacy warehouse of an expired, damaged, returned, or recalled prescription drug to the original manufacturer or original wholesale distributor or to a 3rd-party returns processor or reverse distributor.

Phar 13.02(11)(m) (m) The return of a prescription drug, if the return is authorized by the law of this state.

Phar 13.02(12) (12) “Wholesale distributor” means a person engaged in the wholesale distribution of prescription drugs, including manufacturers; repackagers; own-label distributors; private-label distributors; jobbers; brokers; warehouses, including manufacturers’ and distributors’ warehouses; manufacturers’ exclusive distributors; manufacturers’ authorized distributors of record; prescription drug wholesalers and distributors; independent wholesale prescription drug traders; retail pharmacies that conduct wholesale distribution; and chain pharmacy warehouses that conduct wholesale distribution.

Phar 13.02 History History: Cr. Register, July, 1992, No. 439, eff. 8-1-92; cr. (11) (f), Register, February, 1996, No. 482, eff. 3-1-96; am. (3), Register, December, 1998, No. 516, eff. 1-1-99; EmR0815: emerg. cr. (3m), (11) (b) to (d) and (f) to (m), renum. (6) and (11) (f) to be (12) and (11) (e) and am. (12), am. (8), (9), (11) (intro.) and (a), r. (11) (b) to (e), eff. 6-1-08; CR 08-051: cr. (3m), (11) (b) to (d) and (f) to (m), renum. (6) and (11) (f) to be (12) and (11) (e) and am. (12), am. (8), (9), (11) (intro.) and (a), r. (11) (b) to (e) Register November 2008 No. 635, eff. 12-1-08; correction in (3m) made under s. 13.92 (4) (b) 6., Stats., Register November 2011 No. 671; CR 18-034: am. (12) Register October 2018 No. 754, eff. 11-1-18.

Phar 13.05 Phar 13.05 License; other requirements. In addition to providing the application information, to obtain a license a person shall:

Phar 13.05(1) (1) Pay the fee specified in s. 440.05 (1), Stats.

Phar 13.05(2) (2) Pass an inspection of the facility conducted by the board or its representative in the 3-year period immediately preceding the date of the application by the board, a pharmacy examining board of another state, the National Association of Boards of Pharmacy, or another accrediting body recognized by the board, with the date of each inspection to determine if the location meets standards specified in ss. Phar 13.08 to 13.11.

Phar 13.05(3) (3) Register with the drug enforcement administration, if intending to distribute controlled substances.

Phar 13.05 Note Note: Copies of federal applications may be obtained from the Drug Enforcement Administration, Suite 500, Dirksen Federal Building, 219 South Dearborn Street, Chicago, Illinois 60604. Copies of federal statutes and rules may be obtained from the Superintendent of Documents, Government Printing Office, Washington DC 20402-9325.

Phar 13.05 History History: Cr. Register, July, 1992, No. 439, eff. 8-1-92; CR 00-157: am. (2) Register May 2002 No. 557, eff. 6-1-02; EmR0815: emerg. am. (2), eff. 6-1-08; CR 08-051: am. (2) Register November 2008 No. 635, eff. 12-1-08.

Phar 13.055 Phar 13.055 Surety bond, irrevocable letter of credit. The applicant shall supply a surety bond or irrevocable letter of credit in the amount of $5,000.00, which is issued by a company authorized to do business in Wisconsin. The form of the bond or letter of credit shall be approved by the department and conditioned so that the state shall be fully compensated or reimbursed for, and shall be used to, secure payment of fees or costs that relate to the issuance of a wholesale distributor’s license that have not been paid within 30 days after the fees or costs have become final. The bond or letter shall be valid for the entire period of an unexpired license issued to the applicant. No claim may be made against a bond or other security under this section more than one year after the date on which the applicant’s wholesale distributor’s license expires.

Phar 13.055 History History: EmR0815: emerg. cr. eff. 6-1-08; CR 08-051: cr. Register November 2008 No. 635, eff. 12-1-08.

Phar 13.06 Phar 13.06 License; factors considered. In determining eligibility for a distributor’s license, the board shall consider the following factors:

Phar 13.06(1) (1) Any convictions of the applicant under any federal, state, or local laws relating to drug samples, wholesale or retail drug or device distribution, or distribution of controlled substances;

Phar 13.06(2) (2) Any felony convictions of the applicant under federal, state, or local laws, the circumstances of which are substantially related to the practice of a distributor;

Phar 13.06(4) (4) The furnishing by the applicant of false or fraudulent material in any application made in connection with drug manufacturing or distribution;

Phar 13.06(5) (5) Suspension or revocation by federal, state, or local government of any license currently or previously held by the applicant for the manufacture or distribution of any devices or drugs, including controlled substances;

Phar 13.06(6) (6) Compliance with licensing requirements under previously granted licenses, if any;

Phar 13.06(7) (7) Compliance with the requirements to maintain or make available to a state licensing authority or to federal, state, or local law enforcement officials those records required to be maintained by wholesale drug or device distributors; and

Phar 13.06(8) (8) Any other factors or qualifications the board considers relevant to and consistent with the public health and safety.

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.

Phar 13.12 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 13.13 Phar 13.13 Returned, damaged and outdated prescription drug requirements.