Calculation workspace
Preparation calculators
The arithmetic tool uses your inputs. The BUD screen uses visibly dated historical rules whose clinical qualification remains pending.
Historical rule calculation ; not a validated BUD assignment
BUD and immediate-use screening
These historical compounding rules await current evidence review. The result demonstrates the selected rule and entered limits; it does not certify category eligibility, current USP compliance, product stability, or an assigned clinical BUD.
Select an explicit scenario, storage condition, date, and time zone. No scenario is selected automatically.
Restored historical rule table and source references
Original wording is preserved below as dated source content, including any historical use of the word "current."
- Version
- USP <797> 2023 framework screening table
Source ID
H51-508E17F512BE47C87AEB19AA - Important
- A sterility-based BUD ceiling is not the same as a manufacturer expiration date or a drug-specific chemical-stability limit.
Source ID
H51-AB5C99BEB9C3F22EB9AECF4C - The assigned BUD cannot exceed the shortest applicable limit, including sterility category, drug stability, container/closure compatibility, component expiration, and institutional policy.
Source ID
H51-223CCD0760702AC3271D2DFA - This calculator cannot determine whether a preparation qualifies for Category 1, Category 2, Category 3, or immediate-use conditions. The compounder must make that determination.
Source ID
H51-3EE05E7F19C70E359D91A0D0 - For immediate-use CSPs, the four-hour value is an administration-start deadline. Do not merge it with a drug-specific completion or discard limit as though all limits govern the same event.
Source ID
H51-48D652B8A90F63E7B736B291
- A sterility-based BUD ceiling is not the same as a manufacturer expiration date or a drug-specific chemical-stability limit.
- Scenarios
Source ID
H51-BDE71190972C4FB542189FB4- Id
- immediate-use
Source ID
H51-768C2CD0A242399FAE5A0A7E - Label
- Immediate-use CSP
Source ID
H51-7310C2EBC64D2FA7C3A4FD0B - Description
- For CSPs that meet every immediate-use condition. Administration must begin within 4 hours after the start of preparation.
Source ID
H51-783F0DC1FFFC6605AB03EE8E - Limits hours
- Controlled room
- 4
Source ID
H51-BA8CB60844DEE358F202BE4D
Source ID
H51-B6A665B881C2D25603EBD2A6- Id
- category-1
Source ID
H51-9C6A83C901B081FCDBE123BF - Label
- Category 1 CSP
Source ID
H51-1CE5E94FE5A0798E6175CD46 - Description
- Prepared in a segregated compounding area and meeting all Category 1 requirements.
Source ID
H51-675DE7B1418743D6084031E5 - Limits hours
- Controlled room
- 12
Source ID
H51-9E46AB8B98FB1D2A000ACA7E - Refrigerated
- 24
Source ID
H51-36CD9810B313FEB2AC14CEC8
Source ID
H51-7B9D98090ADB60F06039F30E- Id
- category-2-aseptic-nonsterile-no-test
Source ID
H51-D24156DBA6454068F93D6D92 - Label
- Category 2: aseptic process, one or more nonsterile starting components, no sterility test
Source ID
H51-9B13497569B4CB05A5C4CB85 - Description
- Maximum ceiling from the current USP <797> framework when all listed conditions are satisfied.
Source ID
H51-592C9AEBE4A17BE11AA6C6CF - Limits hours
- Controlled room
- 24
Source ID
H51-FF159EE98664A64418F5E7A6 - Refrigerated
- 96
Source ID
H51-0AAB0B4417669EF47B28CCA7 - Frozen
- 1080
Source ID
H51-B0D389BB900CD2333A68CE0E
Source ID
H51-3795301480AD79C0285370BA- Id
- category-2-aseptic-sterile-no-test
Source ID
H51-5623876C762626B8EAF8619E - Label
- Category 2: aseptic process, only sterile starting components, no sterility test
Source ID
H51-27011E1C1C03D843146CDA00 - Description
- Maximum ceiling from the current USP <797> framework when all listed conditions are satisfied.
Source ID
H51-FD19102DB27EEB4C8D07F1AB - Limits hours
- Controlled room
- 96
Source ID
H51-AC7FC0F7E16CA8EB544FC3BE - Refrigerated
- 240
Source ID
H51-5C521BE658346259E45EA191 - Frozen
- 1080
Source ID
H51-483A7EAA8157546BC0D5BD92
Source ID
H51-9D286CEF9C567CC27B1453BB- Id
- category-2-aseptic-sterile-tested
Source ID
H51-3D3BFE98A6E6C9B3834429D5 - Label
- Category 2: aseptic process, only sterile starting components, sterility tested
Source ID
H51-2BB5DC1E46F27932B8E4F49D - Description
- Maximum ceiling from the current USP <797> framework when required sterility testing and all other conditions are satisfied.
Source ID
H51-ADF595E842855CD0F4FEADAD - Limits hours
- Controlled room
- 720
Source ID
H51-2584F68A218D2B9E365A3E8D - Refrigerated
- 1080
Source ID
H51-AACD81A919F31140A3B699DD - Frozen
- 1440
Source ID
H51-7D6E664FB1332D65B5A9E023
Source ID
H51-C1262F7430238AAE024785CC- Id
- category-2-terminal-tested
Source ID
H51-25A68A87105CAD447066E5FB - Label
- Category 2: terminally sterilized, sterility tested
Source ID
H51-5CE764B485101920EF33FCDE - Description
- Maximum ceiling from the current USP <797> framework when terminal sterilization, sterility testing, and all other conditions are satisfied.
Source ID
H51-DF2A5A28255F6CB2AD2C9845 - Limits hours
- Controlled room
- 1080
Source ID
H51-6E3B0C0BFB6186CDEE63A1C8 - Refrigerated
- 1440
Source ID
H51-9829F25FAE0639781A742AE7 - Frozen
- 2160
Source ID
H51-598FB646E20AF838D7B83A1F
Source ID
H51-A188B9B3C3772C79701B5E14- Id
- category-3-aseptic-tested
Source ID
H51-112158283E696DBF52249F1E - Label
- Category 3: aseptic process, sterility tested
Source ID
H51-0DD409DEE3427A8E2291CEDA - Description
- Extended ceiling available only when all Category 3 requirements, including stability-indicating data and additional environmental/personnel requirements, are satisfied.
Source ID
H51-E478597F2B0E670BAAADE170 - Limits hours
- Controlled room
- 1440
Source ID
H51-9558FEF1FC2B5FFA338C55C7 - Refrigerated
- 2160
Source ID
H51-37DD6DC43FD086D096272CEE - Frozen
- 2880
Source ID
H51-E6138D9B98A7807980D3F509
Source ID
H51-A16752C421204CCC863CB4BD- Id
- category-3-terminal-tested
Source ID
H51-C7E31DAD5D71AD038EBA8FB8 - Label
- Category 3: terminally sterilized, sterility tested
Source ID
H51-6040AC29A9F68D129608FAE9 - Description
- Extended ceiling available only when all Category 3 requirements are satisfied.
Source ID
H51-4AEEE21EDB37AE78CCD5CFEE - Limits hours
- Controlled room
- 2160
Source ID
H51-5484E73E4DF181DE5670C3B8 - Refrigerated
- 2880
Source ID
H51-95B1E4BBE30677F8B720288A - Frozen
- 4320
Source ID
H51-8C21E5348FE64E463BE7FAF1
- Storage labels
- Controlled room
- Controlled room temperature
Source ID
H51-03C162FB23C1D61F19D885E9 - Refrigerated
- Refrigerated
Source ID
H51-6F746332330D4A3AF2BF87B1 - Frozen
- Frozen
Source ID
H51-BCA3966D4098AF455BF1F6DC
- References
Label Url USP General Chapter <797> Compounding StandardsSource ID
H51-B6BE1933FA424B5B18BDF955Source ID
H51-A16AA219E686C71BE8960994https://www.usp.org/compounding/general-chapter-797 (opens in a new tab) Source ID
H51-E065E5F09CF4942063AB5A97USP Compounding Standards UpdatesSource ID
H51-FD517389541EADD25FD8A069Source ID
H51-14AD7513CB6CB9A10A14E431https://www.usp.org/compounding/updates (opens in a new tab) Source ID
H51-98B102CBDBA99AC6E1BCA624