Professional Documents
Culture Documents
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§ 210.2 21 CFR Ch. I (4–1–18 Edition)
procedures set forth in part 1271 sub- such drug is exempt from compliance
parts C and D of this chapter, in addi- with the regulations in part 211 of this
tion to the regulations in this part and chapter. However, this exemption does
in parts 211, 225, and 226 of this chapter. not apply to an investigational drug
Failure to comply with any applicable for use in a phase 1 study once the in-
regulation set forth in this part, in vestigational drug has been made
parts 211, 225, and 226 of this chapter, in available for use by or for the sponsor
part 1271 subpart C of this chapter, or in a phase 2 or phase 3 study, as de-
in part 1271 subpart D of this chapter scribed in § 312.21(b) and (c) of this
with respect to the manufacture, proc- chapter, or the drug has been lawfully
essing, packing or holding of a drug, marketed. If the investigational drug
renders an HCT/P adulterated under has been made available in a phase 2 or
section 501(a)(2)(B) of the act. Such phase 3 study or the drug has been law-
HCT/P, as well as the person who is re- fully marketed, the drug for use in the
sponsible for the failure to comply, is phase 1 study must comply with part
subject to regulatory action. 211.
[43 FR 45076, Sept. 29, 1978, as amended at 69 [69 FR 29828, May 25, 2004, as amended at 73
FR 29828, May 25, 2004; 74 FR 65431, Dec. 10, FR 40462, July 15, 2008; 74 FR 65431, Dec. 10,
2009] 2009]
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Food and Drug Administration, HHS § 210.3
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Pt. 211 21 CFR Ch. I (4–1–18 Edition)
on which more than one item of label- Subpart F—Production and Process
ing is printed. Controls
[43 FR 45076, Sept. 29, 1978, as amended at 51 211.100 Written procedures; deviations.
FR 7389, Mar. 3, 1986; 58 FR 41353, Aug. 3, 1993; 211.101 Charge-in of components.
73 FR 51931, Sept. 8, 2008; 74 FR 65431, Dec. 10, 211.103 Calculation of yield.
2009] 211.105 Equipment identification.
211.110 Sampling and testing of in-process
PART 211—CURRENT GOOD MAN- materials and drug products.
211.111 Time limitations on production.
UFACTURING PRACTICE FOR FIN- 211.113 Control of microbiological contami-
ISHED PHARMACEUTICALS nation.
211.115 Reprocessing.
Subpart A—General Provisions
Subpart G—Packaging and Labeling
Sec. Control
211.1 Scope.
211.3 Definitions. 211.122 Materials examination and usage
criteria.
Subpart B—Organization and Personnel 211.125 Labeling issuance.
211.130 Packaging and labeling operations.
211.22 Responsibilities of quality control 211.132 Tamper-evident packaging require-
unit. ments for over-the-counter (OTC) human
211.25 Personnel qualifications. drug products.
211.28 Personnel responsibilities. 211.134 Drug product inspection.
211.34 Consultants. 211.137 Expiration dating.
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