(1)The sterility of compounded diagnostics, drugs, nutrients, and radiopharmaceuticals shall be maintained or the compounded drug preparation shall be sterilized when prepared in the following dosage forms:
(a)Aqueous bronchial and nasal inhalations, except nasal dosage forms intended for application;
(b)Baths and soaks for live organs and tissues;
(c)Injections such as colloidal dispersions, emulsions, solutions, and suspensions;
(d)Irrigations for internal body cavities;
(e)Ophthalmic drops and ointments; and
(2)Compounders and sterile prepackagers are responsible for ensuring that sterile products are accurately identified, measured, diluted, and mixed and are correctly purified, sterilized, packaged, sealed, labeled, stored, dispensed, and distributed, as we
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(1) The sterility of compounded diagnostics, drugs, nutrients, and radiopharmaceuticals shall be maintained or the compounded drug preparation shall be sterilized when prepared in the following dosage forms:
(a) Aqueous bronchial and nasal inhalations, except nasal dosage forms intended for application;
(b) Baths and soaks for live organs and tissues;
(c) Injections such as colloidal dispersions, emulsions, solutions, and suspensions;
(d) Irrigations for internal body cavities;
(e) Ophthalmic drops and ointments; and
(f) Tissue implants.
(2) Compounders and sterile prepackagers are responsible for ensuring that sterile products are accurately identified, measured, diluted, and mixed and are correctly purified, sterilized, packaged, sealed, labeled, stored, dispensed, and distributed, as well as prepared in a manner that maintains sterility and minimizes the introduction of particulate matter.
(3) Except when provided for immediate administration, the environment for the preparation of sterile preparations in a drug outlet shall be in an isolated area, designed to avoid unnecessary traffic and airflow disturbances, and equipped to accommodate aseptic techniques and conditions.
(4) The following shall be documented with respect to any sterile preparation:
(a) Justification of beyond use dates assigned pursuant to direct testing or extrapolation from reliable literature sources;
(b) Training records evidencing that personnel are trained on a routine basis and are adequately skilled, educated, and instructed;
(c) Audits appropriate for the risk of contamination for the particular sterile preparation, including visual inspection, periodic hand hygiene and garbing competency, gloved fingertip sampling testing, sterility testing, media-fill test procedures, competency evaluation at least annually for each compounder, and environmental sampling testing at least upon registration of a new drug outlet, upon the servicing or re-certification of facilities and equipment, in response to identified problems, or every six (6) months;
(d) Temperature, logged daily;
(e) Beyond use date and accuracy testing, when appropriate; and
(f) Measuring, mixing, sterilizing, and purification equipment inspection, monitoring, cleaning, and maintenance to ensure accuracy and effectiveness for their intended use.