400-9696-311 转1
400-9696-311 转3
400-9696-311 转4
400-9696-311 转5
400客服电话
购买数据产品
400-9696-311 转1
定制咨询业务
400-9696-311 转2
数据与AI定制业务
400-9696-311 转3
商务合作及其他问题
400-9696-311 转4
投诉及建议
400-9696-311 转5
2018-10-25
FDA-2018-D-3462
指导原则
美国
现行有效
/
美国食品药品监督管理局(FDA)
GUIDANCE DOCUMENT
Not for implementation. Contains non-binding recommendations.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.” The draft guidance addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). Specifically, this draft guidance covers the statutory verification system requirements that include quarantine and investigation of a product determined to be suspect and quarantine and disposition of a product determined to be illegitimate. The draft guidance also addresses the statutory requirement for notification to the Agency of a product that has been cleared by a manufacturer, repackager, wholesale distributor, or dispenser after a suspect product investigation because it is determined that the product is not an illegitimate product.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2018-D-3462.
摩熵医药2026-06-17
摩熵医药2026-06-09
赛柏蓝2026-06-01
深蓝观2026-05-22
赛柏蓝2026-04-24
摩熵医械2026-01-28
摩熵医械2026-01-13
摩熵医械2025-12-19
赛柏蓝2025-12-12
摩熵医械2025-11-28
2026-07-17
2026-07-15
2026-07-03
2026-07-03
2026-07-02
2026-06-30
2026-06-25
2026-06-24
2026-06-23
2026-06-15
2026-06-01
2026-06-01
2026-05-25
2026-05-20
2026-05-13
2024-11-15
2024-11-14
2024-11-01
2024-10-31
2024-10-30
2024-10-24
2024-10-22
2024-10-21
2024-10-17
2024-10-17
2024-10-17
2024-10-17
2024-10-17
2024-10-16
2024-10-15
2026-05-13
2026-05-13
2026-05-13
2026-05-13
2026-05-13
2026-05-08
2026-05-08
2026-05-08
2026-05-08
2026-05-07
2026-05-06
2026-05-05
2026-04-21
2026-04-20
2026-04-20