2014 Missouri Revised Statutes
TITLE XII PUBLIC HEALTH AND WELFARE (188-215)
Chapter 208 Old Age Assistance, Aid to Dependent Children and General Relief
Section 208.550 (Repealed L. 2005 S.B. 539 § A)

208.550. As used in sections 208.550 to 208.571, the following terms mean:

(1) "Clearinghouse", the Missouri Senior Rx clearinghouse established in section 208.571;

(2) "Commission", the commission for the Missouri Senior Rx program established in section 208.553;

(3) "Direct seller", any person, partnership, corporation, institution or entity engaged in the selling of pharmaceutical products directly to consumers in this state;

(4) "Distributor", a private entity under contract with the original labeler or holder of the national code number to manufacture, package or market the covered prescription drug;

(5) "Division", the division of aging within the department of health and senior services;

(6) "FDA", the Food and Drug Administration of the Public Health Services of the Department of Health and Human Services;

(7) "Generic drug", a chemically equivalent copy of a brand-name drug for which the patent has expired. Drug formulations must be of identical composition with respect to the active ingredient and must meet official standards of identity, purity, and quality of active ingredient as approved by the Food and Drug Administration;

(8) "Household income", the amount of income as defined in section 135.010, RSMo. For purposes of this section, household income shall be the household income of the applicant for the previous calendar year;

(9) "Innovator multiple-source drugs", a multiple-source drug that was originally marketed under a new drug application approved by the FDA. The term includes:

(a) Covered prescription drugs approved under Product License Approval (PLA), Establishment Licenses Approval (ELA), or Antibiotic Drug Approval (ADA); and

(b) A covered prescription drug marketed by a cross-licensed producer or distributor under the Approved New Drug Application (ANDA) when the drug product meets this definition;

(10) "Manufacturer", shall include:

(a) An entity which is engaged in any of the following:

a. The production, preparation, propagation, compounding, conversion or processing of prescription drug products:

(i) Directly or indirectly by extraction from substances of natural origin;

(ii) Independently by means of chemical synthesis; or

(iii) By a combination of extraction and chemical synthesis;

b. The packaging, repackaging, labeling or relabeling, or distribution of prescription drug products;

(b) The entity holding legal title to or possession of the national drug code number for the covered prescription drug;

(c) The term does not include a wholesale distributor of drugs, drugstore chain organization or retail pharmacy licensed by the state;

(11) "Medicaid", the program for medical assistance established pursuant to Title XIX of the federal Social Security Act and administered by the department of social services;

(12) "Missouri resident", an individual who establishes residence for a period of twelve months in a settled or permanent home or domicile within the state of Missouri with the intention of remaining in this state. An individual is a resident of this state until the individual establishes a permanent residence outside this state;

(13) "National drug code number", the identifying drug number maintained by the FDA. The complete eleven-digit number must include the labeler code, product code and package size code;

(14) "New drug", a covered prescription drug approved as a new drug under Section 201(p) of the Federal Food, Drug, and Cosmetic Act (52 Stat. 1040, 21 U.S.C. S 321(p));

(15) "Prescription drug", a drug which may be dispensed only upon prescription by an authorized prescriber and which is approved for safety and effectiveness as a prescription drug under Section 505 or 507 of the Federal Food, Drug, and Cosmetic Act;

(16) "Program", the Missouri Senior Rx program established pursuant to section 208.556;

(17) "Single-source drugs", legend drug products for which the FDA has not approved on Abbreviated New Drug Application (ANDA);

(18) "Third-party administrator", a private party contracted to administer the Missouri Senior Rx program established in section 208.556, with duties that may include, but shall not be limited to, devising applications, enrolling members, administration of prescription drug benefits, and implementation of cost-control measures, including such programs as disease management programs, early refill edits, and fraud and abuse detection system and auditing programs;

(19) "Unit", a drug unit in the lowest identifiable amount, such as tablet or capsule for solid dosage forms, milliliter for liquid forms and gram for ointments or creams. The manufacturer shall specify the unit for each dosage form and strength of each covered prescription drug in accordance with the instructions developed by the Center for Medicare and Medicaid Services (CMS) for purposes of the Federal Medicaid Rebate Program under Section 1927 of Title XIX of the Social Security Act (49 Stat. 620, 42 U.S.C. Section 301 et seq.);

(20) "Wholesaler", any person, partnership, corporation, institution or entity to which the manufacturer sells the covered prescription drug, including a pharmacy or chain of pharmacies.