Colorado WIC Program Policies and Procedures Section 2: Nutrition Services Revised: 03/01/2026

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Food Packages - Prescription-Required Formula and Nutritionals Policy: Local agency WIC staff may issue approved medical formulas and nutritionals to infants, children and women based upon qualifying medical conditions and receipt of medical documentation from a healthcare provider licensed to write prescriptions in Colorado (MD, PA, DO, NP). The WIC High Risk Counselor must approve prescriptions for prescription-required formulas prior to issuance. Supplemental foods may also be issued as an accompaniment to the WIC formula.

Regulation: 7 CFR 246.10 Procedure/Additional Guidance: In order to receive a food package with a prescription required formula or nutritional, participants must have one or more qualifying conditions that impair ingestion, digestion, absorption or the utilization of nutrients that could adversely affect the participant’s nutritional status, and the use of conventional foods is precluded, restricted, or inadequate to meet their special nutritional needs as determined by a health care professional licensed under State law to write medical prescriptions.

The qualifying conditions include but are not limited to: • premature birth • low birth weight • failure to thrive • inborn errors of metabolism and metabolic disorders immune system disorders • malabsorption syndromes gastrointestinal disorders • severe food allergies that require an elemental formula • life threatening disorders, diseases and medical conditions that impair ingestion, digestion, absorption or the utilization of nutrients that could adversely affect the • participant’s nutritional status

Prescription-Required Formula Package is required in order to issue either of the following:

1. Exempt Infant Formula: Exempt infant formula means an infant formula that meets the requirements for an exempt infant formula under section 412(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(h)) and the regulations at 21 CFR parts 106 and 107. Exempt infant formulas are those that are represented and labeled for use by an infant who has an inborn error of metabolism, a low birth weight or who otherwise has an unusual medical or dietary problem. They are often used with infants who have medical problems that affect their nutritional needs and/or their ability to digest regular infant formulas. It is very important that a physician regularly reevaluate the need and acceptance by an infant receiving an exempt infant formula. 2. WIC Eligible Nutritionals: Certain enteral products that are specifically formulated and commercially manufactured (as opposed to a naturally occurring foodstuff used in its natural state) to provide nutritional support for individuals with a qualifying condition, when the use of conventional foods is precluded, restricted, or inadequate. Such WIC-eligible nutritionals must serve the purpose of a food, meal, or diet (may be nutritionally complete or incomplete) and provide a source of calories and one or more nutrients; be designed for enteral digestion via an oral or tube feeding; and may not be a conventional food, drug, flavoring, or enzyme. WIC-eligible nutritionals include many, but not all, products that meet the definition of medical food in section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)). WIC eligible nutritionals may not be a conventional food, drug, flavoring, or enzyme. Blenderized foods (i.e., conventional foods liquified in a blender) do not meet WIC-eligible nutritionals requirements.

Prescription-Required Formula Package is Not Authorized For: ● Infants whose only condition is: ✔ A diagnosed formula intolerance or food allergy to lactose, sucrose, milk protein or soy protein that does not require the use of an exempt infant formula; or ✔ A non-specific formula or food intolerance. ● Women and children who have an intolerance to lactose or milk protein that can be successfully managed with the use of another WIC food packages; or

Colorado WIC Program Policies and Procedures Section 2: Nutrition Services Revised: 03/01/2026

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● Any participant solely for the purpose of enhancing nutrient intake or managing body weight without an underlying qualifying condition. For example, PediaSure should not be issued for a healthy child for the purpose to enhance the child’s nutritional intake. Issuance of PediaSure is allowed when the child’s health provider specifies its use as part of an overall nutritional plan for a child diagnosed as failure to thrive.

Medical Documentation Acceptable medical documentation from a health care provider must be provided and approved by the WIC High Risk Counselor prior to issuance of exempt infant formulas, WIC eligible nutritionals, and/or supplemental foods. Medical documentation can be written on the Physician’s Authorization Form or a health care provider’s prescription pad and scanned to the participant’s record. When absolutely necessary, all of the required medical documentation information may be obtained by telephone, provided written medical documentation is received within a reasonable amount of time (i.e., one to two weeks’ time). Telephoned requests from a physician must be documented in the participant’s record. All medical documentation must be kept on file (scanned to the participant’s record) at the local clinic.

Medical documentation must include the following: ✔ The name of the authorized WIC formula prescribed, including amount needed per day; ✔ Length of time the prescribed WIC formula is required by the participant; ✔ The qualifying condition(s) (medical reason / diagnosis) for issuance of the authorized WIC formula and ✔ Signature, date and contact information.

Medical Supervision Requirements Due to the nature of the health conditions of participants who are issued WIC formulas that require medical documentation, close medical supervision is essential for each participant’s dietary management. The responsibility remains with the participant’s health care provider for this medical oversight and instruction. It is the responsibility of the WIC High Risk Counselor to ensure that the appropriate type and amounts of supplemental foods prescribed by the participant’s health care provider or authorized by the WIC High Risk Counselor are issued in the participant’s food package. Prescriptions for Out-of-State Transfers A participant presenting as an out-of-state transfer may need an exempt infant formula, WIC eligible nutritional and /or supplemental foods but may not have the required medical documentation. The medical documentation requirement can be satisfied by using one of the following approaches: ● Colorado local agency WIC staff calls the originating WIC clinic and verifies that proper and timely medical documentation was presented there. ● The out-of-state VOC satisfies the medical documentation requirements when the VOC specifies recent issuance of an exempt infant formula, WIC eligible nutritional and /or supplemental foods. In either instance, a description of the approach must be documented in the participant’s Compass record with the plan to secure proper written medical documentation from a medical provider in Colorado. Staff may issue a maximum of one-month formula/food benefits prior to receiving written medical documentation.

Obtaining Formula That Is Unavailable from Local Retailers Refer to the Ordering Instructions for Products Not on Retail Shelves policy in Section 2: Nutrition Services for instructions on obtaining special formula products that are not available from local retailers. Formula Issuance During a Disaster/Emergency For information about providing formula during a natural disaster or emergency, please refer to the policy called Access to WIC Services During Natural Disasters/Emergencies.

Approval Procedures for Prescription Required Formulas The WIC High Risk Counselor must: ● Review and approve or deny the formula request. ● Document appropriate supplemental foods on the approved Physician Authorization Form. Changes to the approved foods may be documented in the participant’s care plan. ● Complete the “WIC USE ONLY” field with his/her signature, date, and the date the prescription expires. ● Ensure completion of the Medical Documentation screen in Compass with the following:

Colorado WIC Program Policies and Procedures Section 2: Nutrition Services Revised: 03/01/2026

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● Rx Expiration Date (expiration date of prescription) ● Medical Diagnosis (choose from drop down list) ● Medical condition o Prematurity o Vegan o Additional nutrients needed for growth/weight gain o Intolerance o Concern of overweight/obesity o Other (if selected, the reason must be entered in the Additional Details field. ● Approved by (name of WIC High Risk Counselor) ● Authority (name of medical provider) ● Doc ID (as labeled by staff) ● Scan the signed prescription into the family’s record in Compass. If the WIC High Risk Counselor is not available to complete the Medical Documentation field, the Educator may first obtain verbal approval from the WIC High Risk Counselor and then complete the screen.

If the WIC High Risk Counselor is unavailable, the WIC Educator can call a State WIC Nutrition Consultant for issuance approval. In those situations, the WIC Educator must document issuance authorization details in the participant's record and communicate with the WIC High Risk Counselor to review as soon as possible.

Roles and Responsibilities of the Health Care Provider, WIC High Risk Counselor & WIC Educator Health Care Provider’s Role: ● Selects the formula/product and (unless defers to WIC High Risk Counselor) appropriate supplemental foods from a list of allowable WIC products, educates the participant/family on its use, and monitors tolerance, growth, hemoglobin, improvement of symptoms, etc., and continued need. Provides the endorser/participant Medical Documentation in the form of a prescription or the Colorado WIC Program’s Physician Authorization Form. Complete Medical Documentation includes the following required information: ✔ Name of the authorized WIC formula prescribed, including amount needed per day; ✔ Length of time the prescribed WIC formula is required by the participant; ✔ Medical reason/diagnosis for issuance of the authorized WIC formula; ✔ Authorized supplemental foods (unless deferred to WIC High Risk Counselor); and ✔ Signature, date and contact information. ● Provides the participant with a starter supply of the formula/product when it is needed immediately, to allow the WIC clinic to schedule an appointment for the participant and to arrange stocking with the retailer. ● In addition to a physician (MD), medical documentation can be completed and signed by a physician assistant (PA), a doctor of osteopathy (DO), a nurse practitioner (NP), or a health care professional licensed to write medical prescriptions in Colorado. The WIC High Risk Counselor’s Role: The following responsibilities of the WIC High Risk Counselor may never be delegated to paraprofessional staff: ● Works in partnership with the physician to provide the formula/product that best meets the participant's needs. Contacts the physician when more information is needed and helps differentiate among the available products to assist the physician in prescribing. ● Reviews the Medical Documentation for completeness and appropriateness for the participant's needs.Maintains all medical documentation in the participant's record. ● Reviews participant record to determine the participant's age, growth, development, symptoms, and diagnosis. ● Reviews history of WIC food package issuance to determine what previous formulas and/or nutritionals and supplemental foods the participant has been issued. How long has the participant used these formulas and what were the symptoms? ● Reviews product list to determine the recommended use, nutritional information, and any cautions mentioned for the prescribed product. ● Determines the appropriate supplemental foods, prescribed amounts, and length of time required. ● Contacts the physician, as needed, to discuss concerns about the prescribed formula and/or supplemental foods.

Colorado WIC Program Policies and Procedures Section 2: Nutrition Services Revised: 03/01/2026

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● Discusses the following as needed

✔ Participant's weight history, previous formulas, and reported symptoms. ✔ Other formulas and nutrition products that are WIC approved. ✔ The prescription form and the maximum time prescription are valid. ✔ Instructions for dilution and amount of formula needed. ✔ Amount of formula that WIC can issue and how participant can purchase or obtain additional formula. ✔ Using a less expensive product or changing to a WIC-approved formula to help the participant as much as possible. ● The plan to assess the use of the product (examples: use 1 month and see physician) ● Determines the length of time the product and/or supplemental foods can be issued without a new prescription. The time limit should not exceed the maximum time that the prescription is valid. ● Signs and dates the Physician Authorization Form in the “WIC Use Only” area and scans to the participant’s record. Notes when a new prescription is needed (try to combine with a scheduled WIC mid-certification or recertification appointment to avoid having the participant return for extra appointments). ● Reinforces the physician's recommendations for use of the formula, dilution instructions and any additional supplemental foods. ● Contacts a State WIC nutrition consultant to discuss an order for a formula/product not WIC approved or for consultation regarding a formula/product or medical diagnosis. ● Documents in the WIC participant’s care plan to ensure continuity of care: appropriate follow up, education, future directions. Documentation includes formula preparation and dilution instructions provided and any issues encountered with the pharmacy and ordering the special product. ● Makes appropriate referrals to ensure follow up and evaluation (physician, public health nurse, home health care, Department of Social Services, EFNEP, etc.). Is prepared to discuss the following: ✔ Will safety and tolerance be concerns if the product is issued? ✔ Is there adequate measuring equipment available for the participant to use? ✔ Does the participant need help to provide the correct dilution and amount of formula? ✔ Is there a plan for a health care provider to see the participant and evaluate tolerance and continued use of the product? These issues are often a concern with formula exceeding 24 kcal/oz and if the formula requires the addition of other ingredients (carbohydrates, MCT oil, vitamin supplements, etc.). ● Follows the high risk protocol regarding seeing participants and providing necessary documentation when exempt infant formulas and WIC eligible nutritionals are issued to WIC participants. ● Ensures availability of the formula/product by placing an order with a WIC-approved vendor. If the formula/product is not available locally, submits an order to the State Office following the procedure: eWIC Ordering Instructions for Products Not on Retail Shelves for Local Agencies.

The WIC Educator's Role: ● Refers to the Medical Documentation to see the WIC High Risk Counselor’s notations regarding the length of time the product will be issued. ● Reviews the care plan that has been completed by the WIC High Risk Counselor. Follows any instructions that are given such as food package to provide, number of month’s benefits to issue, what retailer to contact, what education to review with the participant or education materials to provide, and when the participant needs to return to the WIC clinic. ● Explains to the participant when the next prescription or authorization is needed and provides the participant with a Physician Authorization Form to bring to the next WIC appointment ● Contacts the WIC retailer as needed to arrange for the product to be stocked, gives timelines for expected use and determines when it will be available. ● Follows the high risk protocol and schedules the participant to see the WIC High Risk Counselor as needed.

Colorado WIC Program Policies and Procedures Section 2: Nutrition Services Revised: 03/01/2026

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Formula and Supplemental Food Amounts for Infants, Children, and Women: Monthly Maximum Amounts Infant 0-3 mo Infant 4-5 mo Infant 6-11 mo Child 1-4 years Women Formulaa (reconstitute d ounces) (Exempt Infant Formulaa or WIC eligible nutritionals only) 870 oz powder -or- 806 oz concentrate -or- 832 oz RTF 960 oz powder -or- 884 oz concentrate -or- 913 oz RTF 696 oz powder -or- 624 oz concentrate -or- 643 oz RTF Formulaa (Infant formula, Exempt infant formula or WIC eligible nutritionals) 910 ounces reconstituted formula (powdered, concentrate or ready-to feed) 910 ounces reconstitute d formula (powder, concentrate or ready-to feed) Supplemental foods None None *Age appropriate supplemental infant foods may be approved for issuance by WIC High Risk Counselor **Age appropriate supplemental child foods may be approved for issuance by WIC High Risk Counselor **Category appropriate supplemental foods may be approved for issuance by WIC High Risk Counselor

NOTE: Issuance of Special and Metabolic food packages always requires a written order from an authorized health care provider for the formula. * With medical documentation, infants 6-11 months of age with a medical condition that precludes food may receive the same amount of contract formula, exempt infant formula or WIC eligible nutritionals as 4-5 month old infants in lieu of infant foods (infant cereal, bananas, baby fruits and vegetables).

** With medical documentation, children and women whose special dietary needs require the use of pureed foods (in addition to requiring the use of a special formula) may receive jarred infant food fruits and vegetables in lieu of the cash value benefit.

Colorado WIC Program: Authorized Formulas and Nutritionals Please review the maximum allowable amount of formulas authorized by Colorado WIC tables for current approved formulas and nutritionals, as well as more detailed information on these options. a Colorado WIC uses the Full Nutrition Benefit (FNB) for concentrate formulas and the Maximum Monthly Allowance (MMA) for powder and RTF formulas.