Importation of Active Pharmaceutical Ingredient (API) Requirements

Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Importation of Active Pharmaceutical Ingredient (API) Requirements
July 16, 2008

Presentation: Bill Nychis, Acting Team Leader, US FDA

Tab	Table of Contents: Reference Materials
A	7-16-08 FDA NYK-DO API Seminar Presentation Notes
B	FD&C Act 201(g) & (p) [21 USC 321(g) & (p)] Definitions; generally
C	FD&C Act 502(f) & (o) [21 USC 352(f) & (o)] Misbranded drugs and devices
D	FD&C Act 503(b)(1) [21 USC 353(b)(1)] Exemptions and consideration for certain drugs, devices, and biological products
E	FD&C Act 505 [21 USC 355] New Drugs
F	FD&C Act 510(i) [21 USC 360(i)] Registration of producers of drugs or devices
G	FD&C Act 801 [21 USC 381] Imports and Exports
H	FD&C Act 802 [21 USC 382] Exports of certain unapproved products
I	FD&C Act 803 [21 USC 383] Office of International Relations
J	21 CFR § 201 Drugs; adequate directions for use
K	21 CFR § 207.3 Definitions; 207.35 R&L; 207.40 R&L
L	21 CFR § 312.160 Drugs for investigational use in laboratory research animals or in vitro tests
M	CPG 460.200 Pharmacy Compounding Compliance Policy Guides Manual
N	Draft Guidance: E-Registration & Listing: FRN Vol. 73, No. 134, 7/11/08, Page 39964

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Date created: July 16, 2008



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