Generic Drug Substitution

PURPOSE: The purpose of this rule is to establish requirements for generic drug substitution. PUBLISHER’S NOTE: The secretary of state has determined that the publication of the entire text of the material which is incorporated by reference as a portion of this rule would be unduly cumbersome or expensive. This material as incorporated by reference in this rule shall be maintained by the agency at its headquarters and shall be made available to the public for inspection and copying at no more than the actual cost of reproduction. This note applies only to the reference material. The entire text of the rule is printed here. (1) Except as otherwise provided by Chapter 338, RSMo, a pharmacist who receives a prescription for a brand name drug or biological product may select a less expensive generically equivalent or interchangeable biological product unless the patient requests a brand named drug or biological product or the prescribing practitioner indicates that substitution is prohibited or displays "brand medically necessary", "dispense as written", "do not substitute", "DAW", or words of similar import on the prescription. (2) All pharmacists and dispensing physicians should be warned that any drug product not holding an approved New Drug Application or Abbreviated New Drug Application may not be used as a substitute in the state of Missouri without the dispenser assuming some personal liability. (3) A pharmacist shall not substitute drug products that are rated as therapeutically inequivalent to other pharmaceutically equivalent products as listed in the latest edition or cumulative supplement of The Approved Drug Products with Therapeutic Equivalence Evaluations published by the United States Government, Department of Health and Human Services. AUTHORITY: section 338.280, RSMo 2016, and section 338.140, RSMo Supp. 2019.* This rule originally filed as 4 CSR 220-3.011. Emergency rule filed April 26, 1979, effective May 6, 1979, expired Aug. 12, 1979. Original rule filed April 26, 1979, effective Aug. 13, 1979. Emergency amendment filed April 14, 1982, effective April 24, 1982, expired Aug. 22, 1982. Amended: Filed April 14, 1982, effective July 11, 1982. Emergency amendment filed June 14, 1982, effective July 15, 1982, expired Oct. 12, 1982. Amended: Filed June 14, 1982, effective Sept. 11, 1982. Emergency amendment filed Dec. 6, 1982, effective Jan. 1, 1983, expired March 10, 1983. Amended: Filed Dec. 6, 1982, effective March 11, 1983. Emergency amendment filed June 14, 1983, effective July 15, 1983, expired Sept. 15, 1983. Amended: Filed June 14, 1983, effective Sept. 11, 1983. Emergency amendment filed Dec. 12, 1983, effective Jan. 1, 1984, expired March 14, 1984. Amended: Filed Dec. 12, 1983, effective May 11, 1984. Emergency amendment filed Feb. 3, 1984, effective Feb. 13, 1984, expired June 12, 1984. Emergency amendment filed June 20, 1984, effective June 30, 1984, expired Oct. 28, 1984. Amended: Filed July 9, 1984, effective Oct. 11, 1984. Emergency amendment filed Dec. 10, 1984, effective Dec. 20, 1984, expired April 19, 1985. Amended: Filed Dec. 11, 1984, effective March 11, 1985. Emergency amendment filed Jan. 18, 1985, effective Jan. 28, 1985, expired May 28, 1985. Emergency amendment filed June 14, 1985, effective June 24, 1985, expired Oct. 12, 1985. Amended: Filed June 14, 1985, effective Sept. 27, 1985. Emergency amendment filed Dec. 23, 1985, effective Jan. 2, 1986, expired June 2, 1986. Amended: Filed Dec. 23, 1985, effective May 11, 1986. Emergency amendment filed June 21, 1986, effective July 1, 1986, expired Oct. 28, 1986. Amended: Filed June 23, 1986, effective Sept. 26, 1986. Emergency amendment filed Dec. 10, 1986, effective Dec. 20, 1986, expired April 19, 1987. Amended: Filed Dec. 10, 1986, effective April 11, 1987. Emergency amendment filed July 5, 1987, effective July 20, 1987, expired Nov. 17, 1987. Amended: Filed July 7, 1987, effective Oct. 25, 1987. Emergency amendment filed Jan. 19, 1988, effective Feb. 1, 1988, expired May 30, 1988. Amended: Filed Jan. 19, 1988, effective April 28, 1988. Amended: Filed April 15, 1988, effective Jan. 1, 1989. Emergency amendment filed July 5, 1988, effective July 15, 1988, expired Nov. 12, 1988. Amended: Filed July 5, 1988, effective Nov. 11, 1988. Emergency amendment filed Jan. 19, 1989, effective Feb. 10, 1989, expired May 19, 1989. Amended: Filed Jan. 19, 1989, effective May 11, 1989. Amended: Filed March 31, 1989, effective Sept. 1, 1989. Amended: Filed Aug. 25, 1995, effective April 30, 1996. Moved to 20 CSR 22203.011, effective Aug. 28, 2006. Amended: Filed April 15, 2019, effective Nov. 30, 2019. ** *Original authority: 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011, 2019 and 338.280, RSMo 1951, amended 1971, 1981. **Pursuant to Executive Order 21-09, 20 CSR 2220-3.011, section (3) was suspended from April 16, 2020 through December 31, 2021.