Missouri Code of State Regulations
Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE
Division 2220 - State Board of Pharmacy
Chapter 2 - General Rules
Section 20 CSR 2220-2.425 - Required Pharmacy Reporting
Current through Register Vol. 49, No. 6, March 15, 2024
PURPOSE: The purpose of this rule is to establish requirements for reporting compounding information to the Missouri Board of Pharmacy to ensure compliance with state and federal law.
(1) Pharmacies located in Missouri that have distributed or dispensed compounded human drug preparations/products pursuant to prescriptions or medication orders in the previous calendar year, shall annually report the following information on a form provided by the board:
(2) If the figure in subsection (1)(E) is greater than 0.5, the pharmacy shall also report the following information:
(3) The required information shall be reported no later than January 31, each calendar year.
(4) The term "prescription or medication orders for compounded human drug preparations/products" as used above, does not include veterinary drug products, and biological products subject to licensure under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ).
(5) Notwithstanding the above, a pharmacy which participates in and reports all information required by this rule to the National Association of Boards of Pharmacy (NABP) Information Sharing Network shall not be required to also report to the board. Pharmacies reporting to NABP's Sharing Network shall notify the board no later than January 31 each calendar year that information required by this rule has been reported to NABP. A copy of information submitted to NABP pursuant to this rule shall be provided to the board or the board's authorized designee within five (5) business days of a request from the board or authorized board designee.