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 2220-2.400 - Compounding Standards of Practice

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment updates rule language to
				  reference compounded preparations, defines a commercially available product for
				  purposes of compounding, and clarifies requirements for bulk drug substances
				  for use in compounding human preparations.
(1) Compounding is defined as the
				preparation, incorporation, mixing and packaging or labeling of a drug or
				device as the result of a prescriber's prescription or prescription drug order
				based on the prescriber/patient/pharmacist relationship in the course of
				professional practice. Compounding may also be defined as the preparation,
				incorporation, mixing and packaging or labeling of a drug or device, for the
				purpose of, or as an incident to, research, teaching or chemical analysis and
				not for sale or dispensing purposes.
(2) Manufacturing is defined as the
				production, preparation, propagation, conversion, or processing of a drug or
				device, either directly or indirectly, by extraction from substances of natural
				origin or independently by means of chemical or biological synthesis, and
				includes any packaging or repackaging of the substance(s) or labeling or
				relabeling of its container, and the promotion and marketing of such drugs or
				devices.
(3) Batch compounded
				preparation is defined as a preparation compounded in advance of receipt of a
				prescription or a preparation compounded in a supply that will be used on more
				than one (1) dispensing to a patient or patients or any preparation compounded
				in excess of the filling of an individual prescription. A batch is a specific
				quantity of preparation compounded in a single, discrete process, by the same
				individuals, carried out during one (1) limited time period.
(4) Beyond-use date: A date after which a
				compounded preparation should not be used and is determined from the date the
				preparation is compounded. Because compounded preparations are intended for
				administration immediately or following short-term storage, their beyond-use
				dates must be assigned based on criteria different from those applied to
				assigning expiration dates to manufactured drug products.
(5) Compounding Area and Equipment
				Requirements.
(A) The area(s) used for
				compounding preparations shall be maintained in a sanitary condition and shall
				be free of infestation by insects, rodents, and other vermin. Trash shall be
				held and disposed of in a timely and sanitary manner.
(B) If drug products with special precautions
				for contamination, such as penicillin, are involved in a compounding operation,
				appropriate measures, including either the dedication of equipment for such
				operations or the meticulous cleaning of contaminated equipment prior to its
				return to inventory, must be utilized in order to prevent
				cross-contamination.
(C) Equipment
				used in compounding preparations shall be of appropriate design, adequate size,
				and suitably located to facilitate operations for its intended use and for its
				cleaning and maintenance. Equipment used in compounding preparations shall be
				of suitable composition so that surfaces that contact ingredients, in-process
				materials, or compounded preparations shall not be reactive, additive, or
				absorptive so as to alter the safety, identity, strength, quality, or purity of
				the compounded preparation beyond that desired.