IRAs are published in Pharmacopeial Forum (PF) as proposed IRAs. After a 90-day notice and comment period and approval by the relevant USP Expert Committee, IRAs are posted as official text in this location of the USP website, and are incorporated into the next available official publication (USP–NF or Supplement). Official IRAs are no longer published in PF. The PF posting dates, comment deadlines and IRA posting and official dates are outlined in the chart below.
|
PF |
Proposed IRA Posting |
Public Comment Due Date |
Final IRA Posting Date on Web |
IRA Official Date |
|---|---|---|---|---|
| 43(1) | Jan. 1, 2017 | Mar. 31, 2017 | May. 26, 2017 | Jul. 1, 2017 |
| 43(2) | Mar. 1, 2017 | Jul. 31, 2017* | Aug. 25, 2017 | Oct. 1, 2017 |
| 43(3) | May. 1, 2017 | Jul. 31, 2017 | Sep. 29, 2017 | Nov. 1, 2017 |
| 43(4) | Jul. 1, 2017 | Sep. 30, 2017 | Nov. 22, 2017** | Jan. 1, 2018 |
* Extended due to technical issues. See Compendial Notice.
** Posting date adjusted to accommodate Thanksgiving holiday.
Monograph names listed below link to the combined IRA posting in which the announcement appeared.
New IRAs
The following IRAs were published for comment in in PF 43(2):
- Valine
- Amlodipine and Valsaratan Tablets
- Amlodipine, Valsartan, and Hydrochlorothiaide Tablets
- Pyridostigmine Bromide Tablets
- Levocetirizine Dihydrochloride
These were previously scheduled to post on July 28, and become official September 1, 2017; however, because the comment deadline for PF43(2) was extended until July 31st, the new anticipated posting and official date for these IRAs would be August 25, 2017th and October 1, 2017 respectively.
All Posted IRAs
- Acitretin Capsules (posted 18–Nov–2016; official 01–Jan–2017)
- Almotriptan Malate (posted 31–Mar–2017; official 01–May–2017)
- Anastrozole Tablets (posted 27–Jan–2017; official 01–Mar–2017)
- Aspartic Acid (posted 29–Jul–2016; official 01–Sep–2016)
- Aspirin Delayed Release Capsules (posted 18–Nov–2016; official 01–Jan–2017)
- Aspirin Boluses (posted 18–Nov–2016; official 01–Jan–2017)
- Aspirin Delayed Release Tablets (posted 18–Nov–2016; official 01–Jan–2017)
- Aspirin Effervescent Tablets for Oral Solution (posted 18–Nov–2016; official 01–Jan–2017)
- Aspirin Tablets (posted 18–Nov–2016; official 01–Jan–2017)
- Aspirin, Alumina, and Magnesia Tablets (posted 18–Nov–2016; official 01–Jan–2017)
- Aspirin Extended-Release Tablets (posted 18–Nov–2016; official 01–Jan–2017)
- Buffered Aspirin Tablets (posted 18–Nov–2016; official 01–Jan–2017)
- <87> Biological Reactivity Tests, in Vitro (posted 25–Sep–2015; official 01–Nov–2015)
- Ceftriaxone Sodium (posted 24–Jun–2016; official 01–Aug–2016; updated 06–Jul–2016*)
*The Ceftriaxone Sodium IRA posted on June 24, 2016 had the incorrect official date. The IRA was reposted on July 6, 2016 with the correct official date of August 1, 2016. - Ceftriaxone for Injection (posted 24–Jun–2016; official 01–Aug–2016; updated 06–Jul–2016**)
**The incorrect version of the Ceftriaxone for Injection IRA was posted on June 24, 2016. A corrected Ceftriaxone for Injection IRA was posted on July 6, 2016, which includes revisions to Table 1 in the Organic Impurities section. In addition the official date was corrected to be August 1, 2016. - Cisatracurium Besylate (posted 27–May–2016; official 01–Jul–2016)
- Corticotropin Injection (posted 27–May–2016; official 01–Jul–2016)
- Corticotropin for Injection (posted 27–May–2016; official 01–Jul–2016)
- Respository Corticotropin Injection (posted 27–May–2016; official 01–Jul–2016)
- Digoxin (posted 25–Sep–2015; official 01–Nov–2015)
- Doxorubicin Hydrochloride Injection (posted 27–Jan–2017; official 01–Mar–2017)
- Dutasteride (posted 29–Jan–2016; official 01–Mar–2016)
- Eprinomectin (posted 18–Nov–2016; official 01–Jan–2017)
- Glyceryl Tristearate (posted 27–May–2016; official 01–Jul–2016)
- Insulin Glargine (posted 30–Sep–2016; official 01–Nov–2016)
- Insulin Glargine Injection (posted 30–Sep–2016; official 01–Nov–2016)
- Ketorolac Tromethamine (posted 25–Mar–2016; official 01–May–2016)
- Levothyroxine Sodium Tablets (posted 29–Jul–2016; official 01–Sep–2016)
- Liothyronine Sodium (posted 29–Jul–2016; official 01–Sep–2016)
- Levothyroxine Sodium Tablets (posted 29–Jul–2016; official 01–Sep–2016)
- Liothyronine Sodium (posted 29–Jul–2016; official 01–Sep–2016)
- Methocarbamol (posted 20–Nov–2015; official 01–Jan–2016)
- Methylphenidate Hydrochloride Extended-Release Tablets (posted 29–Jan–2016; official 01–Mar–2016)
- Octyldodecanol (posted 18–Nov–2016; official 01–Jan–2017)
- Omega-3-Ethyl Esters Capsules (posted 20–Nov–2015; official 01–Jan–2016)
- Omega-3-Ethyl Esters (posted 20–Nov–2015; official 01–Jan–2016)
- Oxycodone Hydrochloride (posted 25–Sep–2015; official 01–Nov–2015)
- Pimozide Tablets (posted 30–Sep–2016; official 01–Nov–2016)
- Pimozide (posted 30–Sep–2016; official 01–Nov–2016)
- Protamine Sulfate (posted 27–May–2016; official 01–Jul– 2016)
- Protamine Sulfate Injection (posted 20–Nov–2015; official 01–Jan–2016)
- Tamsulosin Hydrochloride (posted 29–Jul–2016; official 01–Sep–2016)
- Topiramate (posted 31–Mar–2017; official 01–May–2017)
- Sesame Oil (posted 29–May–2015; official 01–Jul–2015)
- Sulindac Tablets (posted 26–May–2017; official 01–Jul–2017)