(A) When one of the following changes occurs under federal law with respect to a biological product or interchangeable biological product, the change is automatically effected under this chapter and Chapter 4729 of the Revised Code, subject to any rule adopted under division (B) of this section to the contrary:

Terms Used In Ohio Code 3715.011

  • Biological product: means , except as provided in section 3715. See Ohio Code 3715.01
  • Drug: means :

    (a) Articles recognized in the United States pharmacopoeia and national formulary, or any supplement to them;

    (b) Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;

    (c) Articles, other than food, intended to affect the structure or any function of the body of humans or other animals;

    (d) Articles intended for use as a component of any of the foregoing articles, other than devices or their components, parts, or accessories. See Ohio Code 3715.01

  • Food: means :

    (a) Articles used for food or drink for humans or animals;

    (b) Chewing gum;

    (c) Articles used for components of any such articles. See Ohio Code 3715.01

  • Interchangeable biological product: means , except as provided in section 3715. See Ohio Code 3715.01
  • Rule: includes regulation. See Ohio Code 1.59
  • state: means the state of Ohio. See Ohio Code 1.59
  • United States: includes all the states. See Ohio Code 1.59

(1) An article is added to or removed from the definition of biological product in subsection (i) of section 351 of the “Public Health Service Act,” 42 U.S.C. § 262(i).

(2) The United States food and drug administration determines that a biological product meets the standards for interchangeability set forth in section 351 of the “Public Health Service Act,” 42 U.S.C. § 262(k), and the product is licensed under that subsection.

(3) The United States food and drug administration determines that a biological product no longer meets the standards for interchangeability set forth in section 351 of the “Public Health Service Act,” 42 U.S.C. § 262(k), and the product’s license under that subsection is suspended or revoked.

(B) The state board of pharmacy may adopt rules that exclude a biological product or interchangeable biological product that, pursuant to division (A) of this section, would otherwise be included under this chapter and Chapter 4729 of the Revised Code. The board’s rules shall establish criteria to be used in determining whether a product is to be excluded.

All rules adopted under this division shall be adopted in accordance with Chapter 119 of the Revised Code.

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