View the PDF for 21 CFR Part 211; These links go to the official, published CFR, which is updated annually. As a result, it may not include the most recent changes applied to the CFR. Learn more.

2024年12月24日 · For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Note: If you need help accessing information in different file …

View Title 21 on govinfo.gov; View the PDF for 21 CFR Part 211; These links go to the official, published CFR, which is updated annually. As a result, it may not include the most recent …

If the investigational drug has been made available in a phase 2 or phase 3 study or the drug has been lawfully marketed, the drug for use in the phase 1 study must comply with part 211. [ 69 …

The regulations set forth in this part and in Parts 211 through 226 of this chapter contain the minimum current good manufacturing practice for methods to be used in, and the facilities or …

§ 211.82 - Receipt and storage of untested components, drug product containers, and closures. § 211.84 - Testing and approval or rejection of components, drug product containers, and …

Subpart A—General Provisions (§§ 211.1 - 211.3) Subpart B—Organization and Personnel (§§ 211.22 - 211.34) Subpart C—Buildings and Facilities (§§ 211.42 - 211.58)

part 211 - current good manufacturing practice for finished pharmaceuticals . authority: 21 u.s.c. 321, 351, 352, 355, 360b, 371, 374; 42 u.s.c. 216, 262, 263a, 264. Source: 43 FR 45077, …

for admin-istration to humans or animals. (b) The current good manufacturing practice regulations in this chapter as they pertain to drug products; in parts 600 through 680 of this chapter, as …

title 21 - food and drugs chapter i - food and drug administration, department of health and human services (continued) subchapter c - drugs: general part 211 - current good manufacturing …