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Authorizing Exempt Infant Formula and WIC Eligible Nutritionals for Alabama WIC Alabama WIC maintains a list of authorized exempt infant formulas and WIC eligible nutritionals that may be issued to eligible participants with qualifying medical conditions. Formula selections will be based on federal regulations, product availability, participant needs, clinical appropriateness, and cost effectiveness. The State Agency reserves the authority to determine which medical formulas are approved for issuance through the WIC Program. The review process generally follows the steps below: 1. Gather information and identify potential changes. On an ongoing basis, State WIC Office Nutrition Services staff gather information from a variety of sources to determine whether revisions to the formulary are needed. Information may include: a. Feedback from local agency staff regarding participant and provider needs. b. Input from pediatric specialists, specialty clinics, and other healthcare providers. c. Requests from formula manufacturers. d. Updates to professional nutrition and medical practice guidelines. e. Changes in federal WIC regulations or policy guidance. f. New products entering the market or discontinuation of existing products. g. Product recalls, shortages, or other supply concerns. 2. Evaluate products for authorization. Nutrition Services Staff review existing authorized formulas and any products being considered for addition to the formulary. During this review, staff consider: a. Whether the product meets the federal definition of an exempt infant formula or WIC-eligible nutritional as defined in 7 CFR Part 246.10, Table 4 Requirements and Specifications for Supplemental Foods. b. The clinical purpose of the product and the medical conditions it is intended to treat. c. Current professional practice guidelines, published scientific literature, and recommendations from pediatric specialists. d. Whether similar products are already authorized and if the new product provides additional clinical benefit or fills an unmet need. e. Utilization data, including how frequently comparable formulas are prescribed an disused within the Alabama WIC Program. f. Product availability through established distribution channels. g. Cost effectiveness compared with clinically appropriate alternatives, including consideration of package size, unit cost, and anticipated program impact. 3. Determine authorized products and qualifying conditions. Based on the review, State WIC Office Nutrition Services staff determine which products will be authorized, retained or removed from the formulary. For each authorized product, staff establish the qualifying medical conditions and any applicable issuance guidance to promote consistent statewide authorization. 4. Implement formulary changes. Once changes have been approved, the State WIC Office updates the WIC MIS system and related policy and procedure documents. 5. Communicate changes. The State WIC Office communicates additions, deletions, or revisions to the formulary and associated qualifying conditions to local agencies and healthcare providers through program communications and publishes the updated formulary on the Alabama WIC website for public reference.