(A) As used in the Administrative Code:
(1) "Biological safety cabinet" means a containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment according to "National Sanitation Foundation (NSF) Standard 49".
(2) "Class 100 environment" means an atmospheric environment which contains no more than one hundred particles of 0.5 microns in diameter or larger per cubic foot of air according to "Federal Standard 209E." A class 100 environment is equivalent to ISO class 5.
(3) "Compounding facility" means a site licensed as a terminal distributor of dangerous drugs where the compounding of sterile product prescriptions occurs.
(4) "Cytotoxic" means a drug that has been shown to be carcinogenic or mutagenic to humans through active or passive exposure.
(5) "Parenteral" means a sterile preparation of drugs for injection through one or more layers of the skin.
(6) "Sterile product" means a dosage form free of living microorganisms (aseptic).
(B) Compounded sterile product prescriptions include, but are not limited to, the following preparations:
(1) Total parenteral nutrition (TPN) solutions;
(2) Parenteral analgesic drugs;
(3) Parenteral antibiotics;
(4) Parenteral antineoplastic agents;
(5) Parenteral electrolytes;
(6) Parenteral vitamins;
(7) Irrigating fluids;
(8) Ophthalmic preparations.
(C) Sterile product prescriptions shall not include commercially manufactured products that do not require compounding prior to dispensing.
Eff 7-4-88; 7-1-93; 3-1-99;
Rule promulgated under: RC 119.03
Rule authorized by: RC 3719.28, 4729.26, 4729.66
Rule amplifies: RC 3719.01, 4729.01
R.C. 119.032 review dates: 12/01/2009 and 12/01/2014