(indented item c.) Otics are excluded, and “aqueous” is added before “inhalations” in the list of preparations required to be sterile before dispensing and administration to patients.
[The current ISO 8 is deemed too dangerously dirty by some attendees at the 2004 USP workshops, and by the SCC when considering the following two prudent sources: FDA’s Current Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice (gov/cder/guidance/5882fnl.htm), which states “FDA recommends that the area immediately adjacent to the aseptic processing line meet, at a minimum, Class 10,000 (ISO 7) standards … An area classified at a Class 100,000 (ISO 8 ) air cleanliness level is appropriate for less critical activities (e.g., equipment cleaning).” (second paragraph of this section currently titled Clean Rooms and Barrier Isolators) Placement of objects and devices not essential to compounding in buffer zones and clean rooms is dictated by their measured effect on the required environmental quality of air atmospheres and surfaces.70% Isopropyl Alcohol, IPA, is not required to be sterile [Neither is it prohibited from being sterile].
IPA used to sanitize gloves, surfaces, and critical sites shall remain at least 30 seconds before such materials are contacted to prepare CSPs.
It has since been adopted by some pharmacy regulatory and accrediting bodies, especially some U. state boards of pharmacy, and the Joint Commission on Accreditation of Health Care Organizations, JCAHO. The process to create or revise USP content, which includes opportunity for public involvement, is described in the front pages of each bimonthly issue of USP’s official journal, Pharmacopeial Forum, PF.
The SCC met October 13-14, 2004, during and within five weeks following which it approved the proposed revisions to that are summarized here.
[This exemption has been honored by the JCAHO in 2004].