Section 9789.40.2 - [Operative 7/1/2025] Pharmaceuticals Dispensed and Pharmaceutical Services Rendered By a Pharmacy on or after July 1, 2025(a) The maximum reasonable fee payable for a legend or non-legend drug dispensed by a pharmacy is determined in accordance with this section. The maximum allowable fee is the lower of the drug's ingredient cost, calculated on a per unit basis, times the number of units dispensed, plus the professional dispensing fee, or the pharmacy's usual and customary charge to the public, based on the date the drug is dispensed. (1) The drug's ingredient cost means the "lowest cost" as set forth on the Pharmaceutical Fee Data File, or(2) When a prescriber indicates "Do Not Substitute", "Dispense as Written" or words of similar meaning on a prescription for a brand name drug in compliance with the Business and Professions Code sections 4052.5, 4073, or 4073.5, and has fulfilled the requirements in section 9792.27.7, the drug ingredient cost means the "no substitution cost" as set forth on the Pharmaceutical Fee Data File.(b) The professional dispensing fee is:(1) $10.05 for all pharmacies except those that meet the requirements of subdivision (b)(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.(c)(1) The maximum reasonable fee for a legend or non-legend repackaged drug is the lower of:(A) the drug ingredient cost using the National Drug Code of the underlying drug product from the original labeler as set forth in the Pharmaceutical Fee Data File, calculated on a per unit basis pursuant to subdivision (a)(1) or (a)(2) plus the professional dispensing fee, or(B) the pharmacy's usual and customary charge to the public.(2) If the National Drug Code for the underlying drug product from the original labeler is not in the Pharmaceutical Fee Data File, then the maximum reasonable fee is the lower of: (A) the drug ingredient cost of the lowest priced therapeutically equivalent drug, calculated on a per unit basis pursuant to subdivision (a)(1), plus the professional dispensing fee, or(B) the pharmacy's usual and customary charge to the public.(3) The National Drug Code of the dispensed repackaged drug and the National Drug Code of the underlying drug product shall both be identified on the bill, in accordance with the billing regulations for paper and electronic billing set forth in section 9792.5.1 et seq.(4) For purposes of this section: (A) "Therapeutically equivalent drugs" means drugs that have been assigned the same Therapeutic Equivalence Code starting with the letter "A" in the Food and Drug Administration's publication "Approved Drug Products with Therapeutic Equivalence Evaluations" ("Orange Book".) The Orange Book may be accessed through the Food and Drug Administration's website.(B) "National Drug Code for the underlying drug product from the original labeler" means the National Drug Code of the drug product actually utilized by the repackager in producing the repackaged product.Cal. Code Regs. Tit. 8, § 9789.40.2
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).