Texas Pharmacists to Substitute Biosimilars - Board of Pharmacy Releases New Rules

09/30/2015

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.1 Currently, Texas regulations only allow for the substitution of lower-priced, generically equivalent drugs instead of certain brand name drugs.2 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.3 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.

To reflect these changes in law, the proposed rules amend the Administrative Code to allow pharmacists to dispense “interchangeable” biological products on one of two conditions. First, consistent with the Public Health Service Act, “interchangeable” biological products are “biosimilar” products that produce the same clinical result as the reference product in any given patient and there is no risk in terms of safety or diminished efficacy in alternating or switching between use of the biological product and the reference product.4 If the biological product meets this standard, it can be substituted without intervention from the prescribing physician. Second, pharmacists may dispense “therapeutically equivalent” products, as designated in the most recent edition of the FDA’s Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (i.e., the Purple Book).

Similar to the process with generic drugs, the proposed rules will allow pharmacists to substitute interchangeable biological products for brand name products, unless specifically prohibited by the prescribing physician. Additionally, a pharmacist must inform the patient if an interchangeable biological product exists and ask the patient to choose between the biological product and the prescribed brand.

An important aspect of HB 751 and the proposed rules is a requirement that the pharmacist inform the prescribing physician of the specific product dispensed to the patient, including the product name and the manufacturer or national drug code number. This communication must be recorded in an electronic medical records system or pharmacy benefit management system; information submitted for the payment of claims would suffice. This component provides for streamlined communication between the pharmacist and the prescribing physician.

The proposed rules have been published in the Texas Register for public comment. The comment period ends on October 30, 2015. To view the Texas Board of Pharmacy’s proposed rules, click here. To view HB 751, click here.

For additional information about these rules, regulatory issues or working with the Texas Legislature, please contact:

Michelle “Missy” Apodaca
512.867.8427
michelle.apodaca@haynesboone.com

Kenya Woodruff
214.651.5446
kenya.woodruff@haynesboone.com

____________________

1 40 Tex. Reg. 6545 (2015) (to be codified at 22 Tex. Admin. Code §§ 309.1 – 309.8 (Tex. State Bd. of Pharmacy).
2 Tex. Admin. Code Ann. § 309 (West 2015). 
3 Tex. Occ. Code Ann. § 562 (West 2015).
4 Public Health Service Act § 351, 42 U.S.C. § 262 (2009).

Email Disclaimer