Sterile compounding definition

Sterile compounding means the aseptic processing in a clean air environment of any pharmaceutical preparations that are required to be sterile when they are administered into patient body cavities, central nervous and vascular systems, eyes, and joints, and when used as baths for live organs and tissues, including by not limited to injections (e.g., colloidal dispersions, emulsions, solutions, and suspensions), aqueous bronchial and nasal inhalations, irrigations for wounds and body cavities, ophthalmic drops and ointments, and tissue implants.

Sterile compounding means any manipulation of a sterile or non-sterile product intended to produce a sterile final product.

Sterile compounding means compounding of biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that, under USP 797 Standards, are prepared using aseptic techniques.

Examples of Sterile compounding in a sentence

• Sterile compounding shall be performed in a separate area in compliance with ARTICLE XXVIII of these regulations.

• Sterile compounding shall be performed with a laminar flow hood or other appropriate environmental control device capable of maintaining, during normal activity, at least Class 100 conditions in the work area where sterile compounding is performed.

• Sterile compounding shall not continue when repeated above action level results occur in primary engine controls or ISO 7 or lower rooms.

• Sterile compounding areas and critical areas must be structurally isolated from other areas designated to avoid unnecessary traffic and airflow disturbances, separate from nonsterile compounding areas, and restricted to qualified compounding personnel.

• Sterile compounding in anticipation of future prescription drug or medication orders must be based upon a history of receiving valid prescriptions issued within an established pharmacist/patient/prescriber relationship, provided that in the pharmacist's professional judgment the quantity prepared is stable for the anticipated shelf time.

• Sterile compounding must be performed in a separate area in compliance with Section 40‑43‑88.

• Sterile compounding areas and critical areas must be structurally isolated from other areas designated to avoid unnecessary traffic and airflow disturbances according to USP chapter 797, separate from nonsterile compounding areas, and restricted to qualified compounding personnel.

• Sterile compounding shall be performed within a laminar flow hood or other appropriate environmental control device capable of maintaining, during normal activity, at least Class 100 conditions in the work area where sterile compounding is performed.

• Chatham-Kent has been a leader across the province in protecting people from the dangers of exposure to environmental tobacco smoke.

• Transmit this information to the Social Security Administration, Rail- road Retirement Board, or the Office of Personnel Management, as appropriate, which will adjust the benefit check amounts as appropriate and notify the beneficiaries of their new benefit amount.

More Definitions of Sterile compounding

Sterile compounding means compounding of biologics, diagnostics, drugs, nutrients, and

Sterile compounding means compounding of biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that, under USP 797, must be sterile when administered to patients prepared using aseptic techniques.

Sterile compounding means the aseptic processing in a clean air environment of any pharmaceutical including, but not limited to, the following preparations that are required to be sterile when they are administered to patients: baths and soaks for live organs and tissues, injections (e.g., colloidal dispersions, emulsions, solutions, and suspensions), aqueous bronchial and nasal inhalations, irrigations for wounds and body cavities, ophthalmic drops and ointments, and tissue implants.

Sterile compounding means the aseptic processing in a clean air environment of any pharmaceutical including, but not limited to, the following preparations that are required to be sterile when they are administered to patients: baths and soaks for live organs and tissues, into patient body cavities, central nervous and vascular systems, eyes, and joints, and when used as baths for live organs and tissues, including by not limited to injections (e.g., colloidal dispersions, emulsions, solutions, and suspensions), aqueous bronchial and nasal inhalations, irrigations for wounds and body cavities, ophthalmic drops and ointments, and tissue implants.ITEM 3. Amend rule 657—13.11(155A) as follows: 657—13.11(155A) Low-risk preparations and low-risk preparations with 12-hour or less beyond-use date. 13.11(1) Conditions defined—low-risk preparations. Preparations compounded under all of the followingconditions are at a low risk of contamination.