21 C.F.R. § 158.3
For the purposes of this part the following definitions shall apply:
(f) Acceptance number. The maximum number of defective sample units permitted in the sample in order to consider the lot as meeting the specified requirements. The following acceptance numbers shall apply:
| Lot size (primary container) | Size container | |
|---|---|---|
| n 1 | c 2 | |
| net weight equal to or less than 1 kg (2.2 lb) | ||
| 4,800 or less | 13 | 2 |
| 4,801 to 24,000 | 21 | 3 |
| 24,001 to 48,000 | 29 | 4 |
| 48,001 to 84,000 | 48 | 6 |
| 84,001 to 144,000 | 84 | 9 |
| 144,001 to 240,000 | 126 | 13 |
| Over 240,000 | 200 | 19 |
| net weight greater than 1 kg (2.2 lb) | ||
| Number of Pounds | ||
| 20,000 or less | 13 | 2 |
| More than 20,000 to 100,000 | 21 | 3 |
| More than 100,000 to 200,000 | 29 | 4 |
| More than 200,000 to 400,000 | 48 | 6 |
| More than 400,000 to 600,000 | 84 | 9 |
| More than 600,000 to 1,000,000 | 126 | 13 |
| More than 1,000,000 | 200 | 19 |
| 1 n = number of sample units. | ||
| 2 c = acceptance number. |
[42 FR 14461, Mar. 15, 1977]