Revision Bulletins

Revision Bulletins are posted by the first of each month. Each Revision Bulletin includes the reason for the change, the complete Monograph or General Chapter, and the official publication in which the Revision Bulletin will be incorporated. Revision Bulletins are transferred to the Accelerated Revision History section when the standard is published and becomes official in the next USP–NF book or Supplement.

Change to Revision Bulletin Official Dates

Version 3.0 of the USP Guideline on the Use of Accelerated Processes for Revisions to the USP–NF, which became effective August 31, 2012, included several significant changes related to official dates for Revision Bulletins. Under the Guideline, compliance-related Revisions Bulletins posted at the end of each month will become official the first day of the next month. The purpose of this approach is to help manufacturers comply with compendial requirements, as long as the change does not cause another approved manufacturer to become noncompliant. See the chart below for specific posting and official dates.

New Revision Bulletins
 

• Alfuzosin Hydrochloride Extended-Release Tablets (posted 22–Mar–2013; official 01–May–2013)
• Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets (posted 22–Mar–2013; official 01–Apr–2013)
• Esmolol Hydrochloride (posted 22–Mar–2013; official 01–Apr–2013)
• Imiquimod (posted 22–Mar–2013; official 01–Oct–2013)
• Nitrofurantoin Capsules (posted 22–Mar–2013; official 01–Apr–2013)
• Tacrolimus (posted 22–Mar–2013; official 01–Apr–2013)
• Tobramycin Inhalation Solution (posted 22–Mar–2013; official 01–Apr–2013)
• Vitamin A Oral Liquid Preparation (posted 22–Mar–2013; official 01–Apr–2013)

Revision Bulletins

• <232> Elemental Impurities—Limits and <233> Elemental Impurities—Procedures (posted 28–Jan–2013; official 01–Feb–2013)
• <788> Particulate Matter in Injections (posted 29–Jun–2012; official 01–Jul–2012; updated 05–Jul–2012)
• Adapalene (posted 31–May–2012; official 01–Dec–2012)
• Alfuzosin Hydrochloride Extended-Release Tablets (posted 22–Mar–2013; official 01–May–2013)
• Alprazolam Orally Disintegrating Tablets (posted 27–Apr–2012; official 01–May–2012)
• Beta Carotene (POSTPONEMENT) (posted 30–Nov–2012)
• Beta Carotene Capsules (POSTPONEMENT) (posted 30–Nov–2012)
• Beta Carotene Preparation (POSTPONEMENT) (posted 30–Nov–2012)
• Calcitonin Salmon (posted 30–Mar–2012; official 01–Apr–2012)
• Cetirizine Hydrochloride Tablets (posted 31–Jan–2013; official 01–Feb–2013)
• Cetirizine Hydrochloride Tablets (posted 27–Jul–2012; official 01–Aug–2012)
• Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets (posted 22–Mar–2013; official 01–Apr–2013)
• Citalopram Hydrobromide (posted 28–Sep–2012; official 01–Jan–2013)
• Divalproex Sodium Extended-Release Tablets (posted 31–Jan–2013; official 01–Feb–2013)
• Divalproex Sodium Extended-Release Tablets (posted 27–Apr–2012; official 01–May–2012)
• Docetaxel (posted 30–Mar–2012; official 01–May–2012)
• Docetaxel Injection (posted 27–Apr–2012; official 01–May–2012)
• Doxycycline Hyclate Delayed-Release Tablets (posted 31–May–2012; official 01–Jun–2012)
• Esmolol Hydrochloride (posted 22–Mar–2013; official 01–Apr–2013)
• Famciclovir (posted 27–Jul–2012; official 01–Feb–2013)
• Fentanyl (POSTPONEMENT) (posted 28–Jan–2011; official 01–Feb–2011)
• Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets (posted 30–Nov–2012; official 01–Dec–2012)
• Gelatin (posted 28–Sep–2012; official 01–Apr–2013)
• Imiquimod (posted 22–Mar–2013; official 01–Oct–2013)
• Indomethacin Extended-Release Capsules (posted 29–Dec–2011; official 01–Jan–2012)
• Insulin (posted 31–Jan–2013; official 01–Feb–2013)
• Isophane Insulin Human Suspension (posted 29–Jun–2012; official 01–Jul–2012)
• Isophane Insulin Suspension (posted 29–Jun–2012; official 01–Jul–2012)
• Isosorbide Mononitrate Extended-Release Tablets (posted 27–Jul–2012; official 01–Aug–2012)
• Isotretinoin Capsules (posted 28–Sep–2012; official 01–Oct–2012)
• Levetiracetam Oral Solution (posted 31–Jan–2013; official 01–Feb–2013)
• Losartan Potassium Tablets (posted 27–Apr–2012; official 01–May–2012)
• Meloxicam (posted 24–Feb–2012; official 01–Mar–2012)
• Metformin Hydrochloride Extended-Release Tablets (posted 29–Jun–2012; official 01–Jul–2012)
• Metoprolol Succinate Extended-Release Tablets (posted 27–Jul–2012; official 01–Aug–2012)
• Modafinil Tablets (posted 30–Nov–2012; official 01–Dec–2012)
• Morphine Sulfate Injection (posted 30–Nov–2012; official 01–Dec–2012)
• Mycophenolate Mofetil Capsules (posted 27–Jul–2012; official 01–Aug–2012)
• Nitrofurantoin Capsules (posted 22–Mar–2013; official 01–Apr–2013)
• Olanzapine (posted 31–May–2012; official 01–Jun–2012)
• Olanzapine Tablets (posted 29–Jun–2012; official 01–Jul–2012)
• Oxaliplatin Injection (posted 28–Sep–2012; official 01–Oct–2012)
• Oxcarbazepine Oral Suspension (posted 31–Jan–2013; official 01–Feb–2013)
• Polysorbate 80 (posted 30–Jul–2010; official 01–Oct–2010; updated 28–Jan–2011)
• Pramipexole Dihydrochloride (posted 23–Nov–2011; official 01–Dec–2011)
• Primaquine Phosphate (posted 28–Sep–2012; official 01–Oct–2012)
• Selenious Acid Injection (posted 31–May–2012; official 01–Jun–2012)
• Sucrose (POSTPONEMENT) (posted 30–Mar–2012; official 01–Apr–2012)
• Tacrolimus (posted 22–Mar–2013; official 01–Apr–2013)
• Tacrolimus Capsules (posted 31–Jan–2013; official 01–Feb–2013)
• Talc (POSTPONEMENT) (posted 29–Apr–2011; updated 30–Jun–2011)
• Tobramycin Inhalation Solution (posted 22–Mar–2013; official 01–Apr–2013)
• Valacyclovir Tablets (posted 27–Apr–2012; official 01–May–2012)
• Verapamil Hydrochloride Extended-Release Tablets (posted 31–Jan–2013; official 01–Feb–2013)
• Venlafaxine Hydrochloride Extended-Release Capsules (posted 28–Sep–2012; official 01–Oct–2012)
• Venlafaxine Hydrochloride Extended-Release Capsules (posted 29–Dec–2011; official 01–Jul–2012)
• Vitamin A Oral Liquid Preparation (posted 22–Mar–2013; official 01–Apr–2013)
• Ziprasidone Hydrochloride (posted 30–Nov–2012; official 01–Dec–2012)