HBA-MPM S.B. 1236 76(R) BILL ANALYSIS Office of House Bill AnalysisS.B. 1236 By: Nelson Public Health 4/27/1999 Engrossed BACKGROUND AND PURPOSE Currently, the Safe Medical Devices Act (SMDA) recognizes that some products are actually a combination of two or more products traditionally regulated separately as either drugs, medical devices, or biologics. In1990, Congress enacted the SMDA, in turn amending the Federal Food, Drug, and Cosmetic Act to allow federal and state governments to make significant improvements in the regulation of medical devices and other related products, including combination products. S.B. 1236 subjects wholesale distributors or manufacturers to either Subchapter I (Wholesale Drug Distributors) or Subchapter L (Device Distributors and Manufacturers), Chapter 431, Health and Safety Code, depending on whether the respective primary mode of action of a product is considered a drug or a device. RULEMAKING AUTHORITY It is the opinion of the Office of House Bill Analysis that this bill does not expressly delegate any additional rulemaking authority to a state officer, department, agency, or institution. SECTION BY SECTION ANALYSIS SECTION 1. Amends Subchapter A, Chapter 431, Health and Safety Code, by adding Section 431.006, as follows: Sec. 431.006. CERTAIN COMBINATION PRODUCTS. Provides that if the United States Food and Drug Administration (USFDA) determines, with respect to a product which is both drug and device, that the primary mode of action of the product is as a drug, the person engaging in wholesale distribution of the product is subject to licensure under Subchapter I (Wholesale Drug Distributors), Chapter 431 (Texas Food, Drug, and Cosmetic Act), Health and Safety Code. Provides that if the USFDA determines that the primary mode of the product is as a device, a distributor or manufacturer of the product is subject to licensure under Subchapter L (Device Distributors and Manufacturers), Chapter 431, Health and Safety Code. SECTION 2.Emergency clause. Effective date: upon passage.