21 CFR 206.3 - Definitions.

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There is 1 rule appearing in the Federal Register for 21 CFR Part 206. View below or at eCFR (GPOAccess)
§ 206.3 Definitions.
The following definitions apply to this part:
The act means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
Debossed means imprinted with a mark below the dosage form surface.
Drug product means a finished dosage form, e.g., a tablet or capsule that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients.
Embossed means imprinted with a mark raised above the dosage form surface.
Engraved means imprinted with a code that is cut into the dosage form surface after it has been completed.
Imprinted means marked with an identification code by means of embossing, debossing, engraving, or printing with ink.
Manufacturer means the manufacturer as described in §§ 201.1 and 600.3(t) of this chapter.
Solid oral dosage form means capsules, tablets, or similar drug products intended for oral use.

Title 21 published on 2014-04-01.

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2015-04-03; vol. 80 # 64 - Friday, April 3, 2015
    1. 80 FR 18087 - Food and Drug Administration Regulations; Change of Addresses; Technical Amendment
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective April 3, 2015.
      21 CFR Parts 1, 26, 99, 201, 203, 206, 207, 310, 312, 314, 600, 601, 606, 607, 610, 660, 680, 801, 807, 812, 814, 822, and 1271

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 206 after this date.

  • 2015-04-03; vol. 80 # 64 - Friday, April 3, 2015
    1. 80 FR 18087 - Food and Drug Administration Regulations; Change of Addresses; Technical Amendment
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective April 3, 2015.
      21 CFR Parts 1, 26, 99, 201, 203, 206, 207, 310, 312, 314, 600, 601, 606, 607, 610, 660, 680, 801, 807, 812, 814, 822, and 1271