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) at which time the posting may also be found in the Accelerated Revision History. 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 and USPNF.com |
Incorporated into Print Publication |
IRA Official Date |
|---|---|---|---|---|---|
| 44(4) | Jul. 1, 2018 | Sep. 30, 2018 | Nov. 30, 2018 | Second Supplement to USP 42–NF 37 | Jan. 1, 2019 |
| 44(5) | Sep. 1, 2018 | Nov. 30, 2018 | Jan. 25, 2019 | Second Supplement to USP 42–NF 37 | Mar. 1, 2019 |
| 44(6) | Nov. 1, 2018 | Jan. 31, 2019 | Mar. 29, 2019 | USP 43–NF 38 | May 1, 2019 |
| 45(1) | Jan. 2, 2019 | Mar. 31, 2019 | May 31, 2019 | USP 43– NF 38 | Jul. 1, 2019 |
| 45(2) | Mar. 1, 2019 | May 31, 2019 | Jul. 26, 2019 | First Supplement to USP 43– NF 38 | Sep. 1, 2019 |
| 45(3) | May 1, 2019 | Jul. 31, 2019 | Sep. 27, 2019 | First Supplement to USP 43–NF 38 | Nov. 1, 2019 |
| 45(4) | Jul. 1, 2019 | Sep. 30, 2019 | Nov. 30, 2019 | Second Supplement to USP 43–NF 38 | Jan. 1, 2020 |
Monograph names listed below link to the combined IRA posting in which the announcement appeared.
New IRAs
- Human Insulin Isophane Suspension and Human Insulin Suspension (posted 30–Nov–2018; official 01–Jan– 2019)
- Insulin Aspart Injection (posted 30–Nov–2018; official 01–Jan–2019)
- Insulin Injection (posted 30–Nov–2018; official 01–Jan–2019)
- Insulin (posted 30–Nov–2018; official 01–Jan–2019)
- Insulin Lispro Injection (posted 30–Nov–2018; official 01–Jan–2019)
- Insulin Lispro (posted 30–Nov–2018; official 01–Jan–2019)
- Insulin Zinc Suspension (posted 30–Nov–2018; official 01–Jan–2019)
- Isophane Insulin Human Suspension (posted 30–Nov–2018; official 01–Jan–2019)
- Isophane Insulin Suspension (posted 30–Nov–2018; official 01–Jan–2019)
All Posted IRAs
- Diclofenac Sodium and Misoprostol Delayed-Release Tablets (posted 26–Jan–2018; official 01–Mar–2018)
- Diethyl Sebacate (posted 26–Jan–2018; official 01–Mar–2018)
- Human Insulin Isophane Suspension and Human Insulin Suspension (posted 30–Nov–2018; official 01–Jan– 2019)
- Insulin (posted 30–Nov–2018; official 01–Jan–2019)
- Insulin Aspart Injection (posted 30–Nov–2018; official 01–Jan–2019)
- Insulin Injection (posted 30–Nov–2018; official 01–Jan–2019)
- Insulin Lispro (posted 30–Nov–2018; official 01–Jan–2019)
- Insulin Lispro Injection (posted 30–Nov–2018; official 01–Jan–2019)
- Insulin Zinc Suspension (posted 30–Nov–2018; official 01–Jan–2019)
- Isophane Insulin Human Suspension (posted 30–Nov–2018; official 01–Jan–2019)
- Isophane Insulin Suspension (posted 30–Nov–2018; official 01–Jan–2019)
- Levocetirizine Dihydrochloride (posted 17–Nov–2017; official 01–Jan–2018) | En español
- Naproxen Sodium Tablets (posted 29‒Sep‒2017; official 01‒May‒2018; updated 27–Oct–2017*)
- *The IRA for Naproxen Sodium Tablets was updated on October 27, 2017 to change the official date of the revision from November 1, 2017 to May 1, 2018. In addition, clarifications were made to the calculations statement and Sample stock solution under Organic Impurities section.
- Salix Species Bark (posted 26–Jan–2018; official 01–Mar–2018) | En español
- Salix Species Bark Powder (posted 26–Jan–2018; official 01–Mar–2018) | En español
- Salix Species Bark Dry Extract (posted 26–Jan–2018; official 01–Mar–2018) | En español
