This rule originally filed as 4 CSR 220-3.010. Emergency rule filed Dec. 28, 1978, effective Jan. 7, 1979, expired April 30, 1979. Moved to 20 CSR 2220-3.010, effective Aug. 28, 2006.

40 CSR 2220-3.011 Generic Drug Formulary

PURPOSE: The purpose of this rule is to comply with the section 338.057, RSMo (1986), which directs the Department of Economic Development to publish a list of drug products for which substitution, by a pharmacist shall not be permitted. Noting that there are a number of drug products within a specific drug product category that have been proven bioequivalent and bio available to the Federal Food and Drug Administration, the Depart ment of Economic Development has delineated within a particular drug product category those drugs that may be substituted. The list is dual in nature. There are certain drugs where substitution will not be permitted and there are certain drug products where qualified substitution will be allowed, again only if the drug and manufacturer is specifically designated in the list.

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. Therefore, the material which is so incorporated is on file with the agency who filed this rule, and with the Office of the Secretary of State. Any interested person may view this material at either agency’s headquarters or the same will be made available at the Office of the Secretary of State at a cost not to exceed actual cost of copy reproduction. The entire text of the rule is printed here. This note refers only to the incorporated by reference material.

1. (1) If a written prescription is involved, the prescription form used shall have two (2) signature lines at opposite ends at the bottom of the form. Under the line at the right side shall be clearly printed the words: “Dispense as Written.” Under the line at the left side shall be clearly printed the words “Substitution Permitted.” The prescriber shall communicate the instructions to the pharmacist by signing the appropriate line. No prescription shall be valid without the signature of the prescriber on one (1) of these lines.
2. (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. (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.
4. (4) Any drug that is manufactured by an innovator company under a supplement to their New Drug Application (NDA) for that specific drug may apply to the Missouri Board of Pharmacy for consideration as a drug that is generically equivalent to the innovator product. A written request for such consideration must be accompanied by an affidavit or other acceptable documentation from the Food and Drug Administration (FDA) attesting to the equivalency of the generic product to the innovator product. Once the Missouri Board of Pharmacy determines that the two (2) products are considered generically equivalent under state law, an appropriate notation will be made in the next revision of the Generic Drug Formulary.

AUTHORITY: sections 338.056, 338.057 and 338.140, RSMo 1994.* 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 20 CSR 2220-3 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 2220- 3.011, effective Aug. 28, 2006.

*Original authority: 338.056, RSMo 1978; 338.057, RSMo 1978; and 338.140, RSMo 1939, amended 1981, 1989.