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Marshfield Clinic Pharmacy Policy and Procedure

​​​​​​​​​​​​​​TITLE: Returned Product Policy

PURPOSE: To document procedures for handling of returned goods at Marshfield Clinic Pharmacies and Remote Dispensing Sites.

BACKGROUND: State of Wisconsin Pharmacy Code Phar 8 specifically outlines under what circumstances a pharmacy may accept back product. The following provides guidance for our managers about accepting back product.

I. Acceptance of returned product.

A. Product may only be accepted back if it meets the below criteria.

B. Product that is accepted back may only be returned to our wholesaler, our reverse wholesaler or must be destroyed in accordance with the Pharmacy Waste Handling Policy.

WI LAW:

Phar 7.04 Return or exchange of health items.
(1) In this section:
(a) ‘‘Health item” means drugs, devices, hypodermic syringes, needles or other objects for injecting a drug, medicines, or items of personal hygiene.
(b) ‘‘Inpatient health care facility” means any hospital, nursing home, county home, county mental hospital, tuberculosis sanitarium or similar facility, but does not include community−based residential facilities, jails or prison facilities.
(c) “Original container” means the container in which a health item was sold, distributed or dispensed.
(d) “Resident health care patient” means a patient residing in a community−based residential facility that controls a resident’s prescribed and over−the−counter medications as specified by s. DHS 83.37
(e) “Secured institutional health care patient” means any of the following:
1. A jail inmate patient whose dispensed health items are maintained under the custody and control of the jail pursuant to an approved policy and procedure manual under s. DOC 350.17, containing policies and procedures for the control and administration of medications complying with s. DOC 350.20.
2. A juvenile patient who resides in a secured correctional facility, as defined in s. 938.02 (15m), Stats.; a secured child caring institution, as defined in s. 938.02 (15g), Stats.; a secured group home, as defined in s. 938.02 (15p), Stats.; a secured detention facility, as defined in s. 938.02 (16), Stats.; or a juvenile portion of a county jail whose dispensed health items are maintained under the custody and control of the health services staff as defined in s. DOC 316.02 (6) and provided to a juvenile patient under the provisions of s. DOC 316.03.
Note: Section 938.02 (15m), Stats., was renumbered to s. 938.02 (10p), Stats., by 2005 Wis. Act 344 and the term “secured correctional facility” was changed to “juvenile correctional facility”. Section 938.02 (15p), Stats., was repealed by 2005 Wis. Act 344. Section 938.02 (16), Stats., was renumbered to s. 938.02 (10r), Stats., and “secure detention facility” was changed to “juvenile detention facility” by 2005 Wis. Act 344.
(f) “Tamper−resistant package” means a container bearing a beyond use date that is sealed so that the contents cannot be used without obvious destruction of the seal.

(2) No health items after taken from a pharmacy where sold, distributed or dispensed, may be returned to that pharmacy, except for any of the following:
(a) From an inpatient health care facility, provided they are in their original containers and the pharmacist determines the contents are not adulterated or misbranded.
(b) Where the health items were dispensed in error, were defective, adulterated, misbranded, or dispensed beyond their beyond use date.
(c) When in the professional judgment of the pharmacist substantial harm could result to the public or a patient if they were to remain in the possession of the patient, patient’s family or agent, or other person.
(d) For a secured institutional health care patient or resident health care patient where all of the following apply:
1. The health item was never in the possession and control of the patient.
2. The health item was sold, distributed or dispensed in a tamper−resistant package and, for a drug, includes the beyond use date and manufacturer’s lot number.
3. The health item is not commingled with a different health item unless the health item will be repackaged and redispensed to the same patient.
4. The health item is in its original container and the pharmacist determines the contents are not adulterated or misbranded.
(e) A health item that is prepackaged for consumer use and labeled in compliance with all applicable state and federal laws where all of the following apply:
1. The pharmacist determines that the original package is unopened, sealed and intact and that package labeling is unaltered.
2. The pharmacist determines the contents are not adulterated.

(3) Health items returned to a pharmacy pursuant to sub. (2) (b) and (c), may not be sold, resold, or repackaged and sold or resold, given away, or otherwise distributed or dispensed. Returned health items shall either be destroyed at the pharmacy or delivered for destruction or other disposal by an authorized person or entity.
(3m) Health items returned from a secured institutional health care patient to a pharmacy pursuant to sub. (2) (d), must be segregated in the pharmacy and may not be sold, resold, or repackaged and sold or resold, given away, or otherwise sold, distributed or redispensed other than to a secured institutional health care patient.

(4) It is not a ‘‘return” for a patient or agent of a patient to deliver a previously dispensed drug or device to a pharmacy for the purpose of repackaging and relabeling of that previously dispensed drug or device, and subsequent return of the drug or device for the same patient’s use.
Note: The DEA does not permit the return of controlled substances to a pharmacy from a non−DEA registrant under any circumstances.

(5) It is not a “return” for a patient or agent of a patient to deliver a previously dispensed drug or device to a pharmacy for the purpose of destruction at the pharmacy or other disposal by an authorized person or entity.
Note: Cancer and chronic disease drug returns and redispensing pursuant to ch. DHS 148 are allowed provided the pharmacy follows the requirements in ch. DHS 148.