Illinois Administrative Code › Title 68 - PROFESSIONS AND OCCUPATIONS › Part 1330 - PHARMACY PRACTICE ACT › Subpart F - PHARMACY STANDARDS › Section 1330.640 - Pharmaceutical Compounding Standards

Current through Register Vol. 48, No. 28, July 12, 2024
No person shall compound, or sell or offer for sale,
				  or cause to be compounded, sold or offered for sale any medicine or preparation
				  under or by a name recognized in the United States Pharmacopoeia National
				  Formulary, for internal or external use, which differs from the standard of
				  strength, quality or purity as determined by the test laid down in the United
				  States Pharmacopoeia National Formulary official at the time of such
				  compounding, sale or offering for sale.
(Section 25 of the Act) All
				  pharmaceutical compounding standards, both sterile and nonsterile, shall be
				  governed by the official USP-NF (USP 47-NF 42), as set forth in the 2024
				  edition of United States Pharmacopoeia (USP), 47th
				  Revision and the National Formulary, 42nd Edition,
				  Compounding Compendium, with the exception of USP Chapter <800> as it
				  pertains to the handling of hazardous drugs in health care settings.
a) A pharmacy may only dispense compounded
				drugs pursuant to a valid patient-specific prescription, except as provided in
				this Section.
b) "Office use" means
				the administration of a non-patient specific compounded drug to a patient by a
				practitioner in the practitioner's office or by the practitioner in a health
				care facility or treatment setting. "Office use" does not include a pharmacy's
				delivery of a compounded drug to a prescribing practitioner's office pursuant
				to a valid patient-specific prescription.
c) Sterile compounding for office use is
				prohibited unless the pharmacy is in full compliance with
				21 USC
				353b, including becoming registered as an
				outsourcing facility and licensed as a wholesale drug distributor pursuant to
				the Wholesale Drug Distribution Licensing Act [225 ILCS 120]. However, a
				sterile compounded drug may be delivered to the prescribing practitioner's
				office for administration pursuant to a valid patient-specific
				prescription.
d) A pharmacist may
				dispense and deliver a reasonable quantity of a nonsterile compounded drug to a
				practitioner for office use by the practitioner in accordance with this
				Section, provided:
1) The quantity of
				compounded drug does not exceed the amount a practitioner anticipates may be
				used in the practitioner's office before the expiration of the beyond use date
				of the drug;
2) The quantity of
				compounded drug is reasonable considering the intended use of the compounded
				drug and the nature of the practitioner's practice;
3) The quantity of compounded drug for any
				practitioner, and all practitioners as a whole, is not greater than an amount
				the pharmacy is capable of compounding in compliance with pharmaceutical
				standards for identity, strength, quality and purity of the compounded drug
				that are consistent with United States Pharmacopoeia guidelines;
4) The pharmacy maintains readily retrievable
				records of all compounded drugs ordered by practitioners for office use. The
				records must be maintained for a minimum of five years and shall include:
A) The name, address and phone number of the
				practitioner ordering the compounded drug for office use and the date of the
				order;
B) The name, strength,
				quantity and dosage form of the compounded drug provided, including the number
				of containers and quantity in each;
C) The date the drug was
				compounded;
D) The date the
				compounded drug was provided to the practitioner; and
E) The lot number and beyond-use
				date.
5) The pharmacy
				affixes a label to any compounded drug that is provided for office use. The
				label shall include:
A) The name, address and
				phone number of the compounding pharmacy;
B) The name, strength and dosage form of the
				compounded drug and a list of active ingredients and strengths. If the number
				of active ingredients would prohibit proper labeling, then the pharmacist shall
				provide to the practitioner a complete list of the active ingredients and
				strengths (including those on the label);
C) The pharmacy's lot number and beyond-use
				date;
D) The quantity or amount in
				the container;
E) The appropriate
				ancillary instructions, such as storage instructions, cautionary statements, or
				hazardous drug warning labels when appropriate; and
F) The statement "For Office Use Only - Not
				for Resale".