<<

Monographs and General Chapters Affected by Revision to General Chapter <659> Packaging and Storage Requirements

Type of Posting: Notice of Intent to Revise

Posting Date: 24–Apr–2015

Targeted Official Date: 01–Aug–2016

Expert Committee: General Chapters—Packaging, Storage and Distribution

In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that USP and its Expert Committees, as applicable, intend to revise multiple monographs and General Chapters in response to the revision of General Chapter <659> Packaging and Storage Requirements. In the proposed revision to <659>, it is planned to revise a subsection title from “Sterile Solids Packaging” to “Packaging for Constitution” so as to accurately reflect the section intent.

General Chapter <659> will be published in Pharmacopeial Forum (PF) 41(3) [May–June 2015]. Comments will be accepted until July 31, 2015, the end of the comment period for PF 41(3).

The new references will be incorporated in the First Supplement to USP 39–NF 34 when the revision of <659> becomes official. In the meantime, interested parties are encouraged to send comments on this proposal. Should you have any questions or comments, please contact Desmond Hunt, Senior Scientific Liaison, General Chapters at (301) 816-8341 or [email protected].

USP has identified the following monographs and general chapters that reference General Chapter <659> and thus require some degree of revision to assure the appropriate General Chapter is referenced:

Acetazolamide for Injection Acetylcholine Chloride for Ophthalmic Solution Amifostine for Injection Amobarbital Sodium for Injection for Injectable Suspension Amphotericin B for Injection and for Injection Ampicillin for Injectable Suspension Ampicillin for Injection Azathioprine Sodium for Injection Azithromycin for Injection for Injection for Injection Bleomycin for Injection Capreomycin for Injection for Injection Carboplatin for Injection Carmustine for Injection Nafate for Injection Cefamandole Nafate for Injection for Injection for Injection for Injection for Injection for Injection Ceforanide for Injection for Injection for Injection for Injection for Injection for Injection for Injection for Injection for Injection for Injection Cephradine for Injection Chloramphenicol Sodium Succinate for Injection Chlordiazepoxide Hydrochloride for Injection Chlorothiazide Sodium for Injection Chorionic Gonadotropin for Injection Cilastatin Sodium Cisplatin for Injection Clindamycin for Injection Colistimethate for Injection Corticotropin for Injection Cyclophosphamide for Injection Cytarabine for Injection Dacarbazine for Injection Dactinomycin for Injection Daunorubicin Hydrochloride for Injection Dobutamine for Injection Doxorubicin Hydrochloride for Injection Doxycycline for Injection Epinephrine Bitartrate for Ophthalmic Solution Erythromycin Lactobionate for Injection Ethacrynate Sodium for Injection Fludarabine Phosphate for Injection Ganciclovir for Injection Gemcitabine for Injection Glucagon for Injection Hyaluronidase for Injection Hydrocortisone Sodium Succinate for Injection Idarubicin Hydrochloride for Injection Ifosfamide for Injection and Cilastatin for Injectable Suspension Imipenem and Cilastatin for Injection Indocyanine Green for Injection Indomethacin for Injection Mechlorethamine Hydrochloride for Injection for Injection Methohexital Sodium for Injection Methotrexate for Injection Methylprednisolone Sodium Succinate for Injection for Injection Minocycline for Injection Mitomycin for Injection for Injection Neomycin for Injection for Injection Oxaliplatin for Injection Oxytetracycline for Injection Pamidronate Disodium for Injection G Potassium for Injection Penicillin G Sodium for Injection Phenobarbital Sodium for Injection Phentolamine Mesylate for Injection and for Injection Piperacillin for Injection B for Injection Pralidoxime Chloride for Injection Prednisolone Sodium Succinate for Injection Protamine Sulfate for Injection Rifampin for Injection Secobarbital Sodium for Injection Sodium Nitroprusside for Injection Spectinomycin for Injectable Suspension Streptomycin for Injection Succinylcholine Chloride for Injection Tetracaine Hydrochloride for Injection Tetracycline Hydrochloride for Injection Thiopental Sodium for Injection Thiotepa for Injection Thiothixene Hydrochloride for Injection and for Injection Ticarcillin for Injection Tiletamine and Zolazepam for Injection Tobramycin for Injection Tolbutamide for Injection Tromethamine for Injection Urea for Injection Hydrochloride for Injection Verteporfin for Injection Vinblastine Sulfate for Injection Vincristine Sulfate for Injection Warfarin Sodium for Injection