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. (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:

   1. (A) The number of prescriptions or medication orders for compounded human drug preparations/products that the pharmacy distributed or dispensed interstate during the previous calendar year;
   2. (B) The number of prescriptions or medication orders for compounded human drug preparations/products that the pharmacy dispensed (or caused to be dispensed) from the facility in which the drug preparations/products were compounded during the previous calendar year (e.g., not picked up on-site by the patient or the patient’s designee);
   3. (C) The number of prescription or medication orders for compounded human drug preparations/products dispensed on-site at the pharmacy during the previous calendar year (e.g., picked up by the patient or the patient’s designee);
   4. (D) The sum of the figures from subsections (1)(B) and (1)(C) above; and
   5. (E) The quotient from dividing the figure in subsection (1)(A) by the figure from subsection (1)(D).

2. (2) If the figure in subsection (1)(E) is greater than five tenths (0.5), the pharmacy shall also report the following information:

   1. (A) The total number of prescription or medication orders for sterile compounded human drugs distributed or dispensed interstate during the previous calendar year;
   2. (B) A list of the states where the pharmacy was licensed during the previous calendar year; and
   3. (C) A list of the states into which the pharmacy distributed compounded human drug preparations/products during the previous calendar year.
3. (3) The required information shall be reported no later than January 31, each calendar year.
4. (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. (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.

AUTHORITY: sections 338.010 and 338.140, RSMo Supp. 2020, and sections 338.240 and 338.280, RSMo 2016.* Original rule filed Jan. 7, 2021, effective July 30, 2021. *Original authority: 338.010, RSMo 1939, amended 1951, 1989, 1990, 2007, 2009, 2011, 2014, 2017, 2018, 2019; 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011, 2019; 338.240, RSMo 1951, amended 2011; and 338.280, RSMo 1951, amended 1971, 1981.