Section 9789.40.3 - [Operative 7/1/2025] Compounded Pharmaceuticals Dispensed By a Pharmacy on or after July 1, 2025(a) Except as provided in subdivisions (b)(2) and (c)(1), the maximum reasonable fee payable for a compounded drug dispensed by a pharmacy is the rate that is 100% of the payment allowed by the Medi-Cal payment methodology for compounded drugs, including: (1) drug ingredient costs, and(2) professional dispensing fee, and(3) compounding and sterility fees if applicable.(b)(1) Each ingredient shall be identified using the applicable National Drug Code (NDC) of the ingredient and the corresponding quantity.(2) Notwithstanding Medi-Cal payment policy, ingredients without a valid NDC are not reimbursable.(3) An NDC is presumed to be valid if the NDC is listed in the FDA's National Drug Code Directory as either a finished or unfinished drug product, and does not appear on the excluded drugs database file. The presumption may be rebutted by a showing that the product is not a drug product legally eligible for assignment of an NDC. The National Drug Code Directory may be accessed on the FDA's website.(c)(1) The drug ingredient cost for a compounded drug, calculated based on units used in the compound on the date the drug is dispensed, means the lower of the billed amount for each ingredient or the fee for each ingredient determined pursuant to section 9789.40.2, subdivision (a)(1) ("lowest cost"), or (a)(2) ("no substitution cost".)(2) The metric decimal quantity/units billed for each ingredient is the total amount within the compound regardless of the number of containers.(d) The professional dispensing fee is: (1) $10.05 for all pharmacies except those that meet the requirements of subdivision (d)(2);(2) $13.20 for a pharmacy whose National Provider Identifier is designated by the Medi-Cal National Provider Identifier file as eligible on the date the drug is dispensed.(e) "Compounding fees and sterility fees" means the fees determined pursuant to section 9789.40.4.(f) A compounded drug that is essentially a copy of a commercially available product is not reimbursable. The status of a compounded drug as "essentially a copy of a commercially available drug product" is determined pursuant to applicable federal law and regulation.Cal. Code Regs. Tit. 8, § 9789.40.3
Note: Authority cited: Sections 133, 4603.5, 5307.1 and 5307.3, Labor Code. Reference: Sections 4600, 4603.2 and 5307.1, Labor Code.
1. New section filed 12-11-2024; operative 7/1/2025. Submitted to OAL for filing and printing only pursuant to Government Code section 11340.9(g) (Register 2024, No. 50).