Missouri § 338.085 - Interchangeable biological products, pharmacist may dispense as substitute, when — recordkeeping — rulemaking authority.

§ 338.085. Interchangeable biological products, pharmacist may dispense as substitute, when — recordkeeping — rulemaking authority.

1.  As used in this chapter, the following terms shall mean:

(1)  "Biological product", the same meaning as such term is defined under 42 U.S.C. Section 262;

(2)  "Interchangeable biological product", a biological product that the Food and Drug Administration:

(a)  Has licensed and determined meets the standards for interchangeability under 42 U.S.C. Section 262(k)(4); or

(b)  Has determined is therapeutically equivalent as set forth in the latest edition of or supplement to the Food and Drug Administration's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).

2.  A pharmacist may substitute an interchangeable biological product for a prescribed product only if all of the following conditions are met:

(1)  The substituted product has been determined by the Food and Drug Administration to be an interchangeable biological product with the prescribed biological product;

(2)  The substitution occurs according to the provisions of section 338.056; and

(3)  The pharmacy informs the patient of the substitution.

3.  Within five business days following the dispensing of a biological product, the dispensing pharmacist or the pharmacist's designee shall make an entry of the specific product provided to the patient including the name of the product and manufacturer.  The communication shall be conveyed by making an entry that can be electronically accessed by the prescriber through one of the following means:

(1)  An interoperable electronic medical records system;

(2)  An electronic prescribing technology;

(3)  A pharmacy benefit management system; or

(4)  A pharmacy record.

4.  Entry into an electronic records system as described in this subsection is presumed to provide notice to the prescriber.  Otherwise, if an entry cannot be made under the provisions of subsection 3 of this section, the pharmacist shall communicate the biological product dispensed to the prescriber using facsimile, telephone, electronic transmission, or other prevailing means, except that communication shall not be required if:

(1)  There is no Food and Drug Administration approved interchangeable biological product for the product prescribed; or

(2)  A refill prescription is not changed from the product dispensed on the prior filling of the prescription.

5.  The pharmacist shall maintain records in a manner consistent with section 338.100.

6.  The pharmacist shall label prescriptions in a manner consistent with section 338.059.

7.  The board of pharmacy shall maintain a link on its website to the current list of all biological products determined by the Food and Drug Administration to be interchangeable with a specific biological product.

8.  The board of pharmacy may promulgate rules for compliance with the provisions of this section.  Any rule or portion of a rule, as that term is defined in section 536.010, that is created under the authority delegated in this section shall become effective only if it complies with and is subject to all of the provisions of chapter 536 and, if applicable, section 536.028.  This section and chapter 536 are nonseverable and if any of the powers vested with the general assembly pursuant to chapter 536 to review, to delay the effective date, or to disapprove and annul a rule are subsequently held unconstitutional, then the grant of rulemaking authority and any rule proposed or adopted after August 28, 2016, shall be invalid and void.

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(L. 2016 S.B. 875)

---- end of effective  28 Aug 2016 ----

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