On September 25, 2015, the Texas Board of Pharmacy (“TBP”) issued proposed rules that will allow pharmacists to substitute interchangeable biological products for brand name drugs. Currently, Texas regulations only allow for the substitution of lower-priced, generically equivalent drugs instead of certain brand name drugs. In contrast, the proposed rules allow pharmacists to dispense interchangeable biological products. These rules would implement House Bill 751, which was passed during the 84th Texas Legislative Session. The bill reflects provisions of the Affordable Care Act, which created an abbreviated licensure path for biological products deemed to be “biosimilar” or “interchangeable” with a biological product licensed by the Food and Drug Administration (“FDA”). Similarly, HB 751 has eased the path for the distribution of substitute biological products.

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