Master formulation and compounding records
Ingredients
Ingredient chips: FDA 503A categories and lists, 21 CFR 216.24, and NIOSH hazardous drugs. Check an ingredient in detail, including FDA shortages.
Beyond-use date
Current: 15 days · Storage and duration as the FDA label states them.
Work out the BUD
Beyond-use date
14 days
Refrigerator
- Nonpreserved aqueous dosage form: 14 days, refrigerated.
- A nonpreserved aqueous CNSP must be stored in a refrigerator for this BUD.
USP <795> §10.4 (CNSPs requiring shorter BUDs), Table 4 (BUD limits by type of preparation)
Rules current as of the USP <795> and <797> revisions official November 1, 2023. Verify against the current official USP chapter before assigning a BUD.
Master formulation record: Sacubitril and valsartan oral suspension 4 mg/mL
Oral suspension · Oral · Nonsterile (USP <795>) · Batch 100 mL
Ingredients
| Ingredient | Role | Quantity |
|---|---|---|
| Sacubitril and valsartan | active | |
| Ora-Plus | vehicle | mL |
| Ora-Sweet | vehicle | mL |
Equipment
- Class A prescription balance or electronic balance
- Mortar and pestle
- Graduated cylinder
Compounding steps
- Follow the label's preparation instructions (quoted in the reference).
Quality control
- Visual inspection: uniform appearance, no foreign matter
- Final volume or weight checked
Packaging, storage, and BUD
Container: glass bottle · Storage: Controlled room temperature · BUD: 15 days
Basis: Storage and duration as the FDA label states them. FDA label (ENTRESTO), Dosage and Administration
Labeling
Shake well. Store as directed. Discard after the beyond-use date.
References
- FDA label (ENTRESTO), Dosage and Administration: Preparation of Oral Suspension Using Tablets. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=000dc81d-ab91-450c-8eae-8eb74e72296f
Record contents follow the master formulation and compounding record sections of USP <795> and <797>; check your state board's requirements. For licensed clinicians. Use with clinical judgment.