735.1 Policy 735 Exchange and Handling of Returned Formula August 13, 2019

POLICY Local programs shall exchange and track formula that has been issued through TWIST and subsequently returned as unopened cans to the local program. PURPOSE To ensure program accountability, participant safety, and consistency in handling returned formula. RELEVANT REGULATIONS 7 CFR §246.10¶(c)- Nutrition Tailoring 7 CFR §246.4 (a)(14)(xviii)- List of infant formula wholesalers, distributors, and retailers 7 CFR §246.12(n)- Direct distribution food delivery systems USDA, March 2018, WIC Food Package Policy and Guidance USDA, May 2019, Clarification on Infant Formula Reissuance and Direct Distribution 42 USC 1791 – Bill Emerson Good Samaritan Food Donation Act ORS 30.890 - Oregon Liability Protection

OREGON WIC PPM REFERENCES

♦ 561—Program Integrity: Replacement of Food Benefits ♦ 590—Program Integrity: Participant Violations ♦ 720—General Information on Formula Use ♦ 733—Formula Warehouse TWIST LESSONS AND RELATED RESOURCES Chapter 3, Sec. 5, Lesson 504 - Formula Replacement (FR) and Formula Exchange (FX). DEFINITIONS Formula exchange: The return of unopened cans of formula purchased with Oregon WIC benefits for issuance of new benefits with a different formula. Opened cans of formula cannot be exchanged. Previous months’ benefits cannot be replaced. Formula replacement: Benefits issued and redeemed for formula may be replaced under limited circumstances. See 561 – Program Integrity: Replacement of Food Benefits for additional information.

Exchange and Handling of Returned Formula, Continued 735.2 PROCEDURE When to allow formula exchange 1.0 Participants may return formula that is unopened in order to be issued a different formula. Staff may use the formula exchange process in TWIST to issue benefits for a different formula than originally issued. Listed below are guidelines for when it is appropriate to use this process. See 720—General Information on Formula Use for additional information on formula issuance. 1.1. Participant was issued and purchased the incorrect formula. EXAMPLE: Nutramigen Enflora was the correct formula to select but the staff member selected Neosure by mistake. 1.2. Participant changed formula due to an allergic response or other medical reason after the formula was purchased. EXAMPLE: Participant was issued Similac Advance but is experiencing hives. After talking with their health care provider, they bring in medical documentation to switch to Alimentum. Exchanging formula 2.0 Participants may receive up to the maximum allowable amount of reconstituted ounces of infant formula per age and category. Any opened cans that are not being returned will count against the maximum allowable issuance. When exchanging one formula for another, staff must keep in mind that formulas come in different container sizes and different forms, therefore, the exchange may not be an even one-to-one ratio. See 561−Program Integrity: Replacement of Food Benefits 2.1. Formula purchased with benefits from the previous month cannot be exchanged for new benefits, regardless of when in the month the participant received these benefits. 2.2. Notify participants that they are not to sell, attempt to sell, trade or give away formula purchased through WIC, including internet sales, and that doing so may result in disqualification from the program and/or payment of restitution. See 590−Program Integrity: Participant Violations. 2.3. Returned formula should be accepted without consequence to the participant. Discussion regarding the handling of the returned product should be limited to avoid assigning responsibility for its disposal. 2.4. Formula returned to the clinic may not be re-issued or given to a participant at any time.

Formula Warehouse 3.0 Formula from Formula Warehouse is not to be returned to the Formula Warehouse. Any formula delivered by the FW shall be returned to the local agency and exchanged as outlined in section 1.0. See ♦733—Formula Warehouse for guidelines on reissuing formula via a formula warehouse.

Exchange and Handling of Returned Formula, Continued 735.3 If you need this in large print or an alternate format, please call 971-673-0040. This institution is an equal opportunity provider. Using “Formula Exchange” in TWIST 4.0 Use the “Formula Exchange” function in TWIST when a participant returns formula and needs to be reissued benefits for a different formula. See the TWIST Training Manual, Chapter 3, Section 5, Lesson 504 for instructions on handling formula returns in TWIST. Options for managing returned formula 5.0 Any unopened formula that is returned to the clinic shall be either disposed of or, in the case of bid formulas, may be donated to a food bank. Any returned expired formula must be disposed of. 5.1. Dispose of returned formula that will not be donated within 2 days of receiving it by opening the containers and either dumping in the trash or pouring liquid down a sink. 5.2. Non-medical bid formula may be donated to a food bank. Medical formula may not be donated and must be disposed of. For local agencies that choose to donate bid formula, policies may be developed and vetted through local agency administration and/or legal counsel that meet the requirements set forth in this policy and include: 5.2.1. Verification that the returned formula is unopened/sealed, undamaged, has been properly stored, and has not been subject to a recall. 5.2.2. Verification that the formula is at least 3 months from the expiration date; if the formula is within 3 months from expiration it cannot be donated, and it must be disposed of. 5.3. Local programs shall keep an inventory log to track returned formula and its disposal or donation. Staff shall use the Formula Tracking Sheet, and retain Tracking Sheets on site for 3 years. Minimize Returned Formula 6.0 In order to minimize returned formula, local program staff are encouraged to ask participants to only purchase 1-2 containers of any new formula when it is unknown whether it will be tolerated. 6.1 Do not issue less than what is assigned for the participant’s category. For special medical formulas, issue the amount requested by a health care provider on the medical documentation form.

Exchange and Handling of Returned Formula, Continued 735.4 POLICY HISTORY Date * Major Revision, Minor revision 2/8/2012 Revised 10/13/2016 Revised 1/4/2019 Revised 6/28/19 Major revision 8/13/19 Major revision

The date located at the top of the policy is the implementation date unless an “effective date” is noted on the policy. Policies will become compliance findings 6 months from the implementation date. Release notes can be found in the corresponding document on the Policy and Procedure Manual page. *Major Revisions: Significant content changes made to policy. Minor Revisions: Minor edits, grammatical updates, clarifications, and/or formatting changes have occurred. Date of Origin: Date policy was initially released