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21 CFR 201.302 - Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil.

There is 1 rule appearing in the Federal Register for 21 CFR 201. Select the tab below to view, or View eCFR (GPOAccess)
§ 201.302
Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil.
(a) In the past few years research studies have altered medical opinion as to the usefulness and harmfulness of mineral oil in the human body. These studies have indicated that when mineral oil is used orally near mealtime it interferes with absorption from the digestive tract of provitamin A and the fat-soluble vitamins A, D, and K, and consequently interferes with the utilization of calcium and phosphorus, with the result that the user is left liable to deficiency diseases. When so used in pregnancy it predisposes to hemorrhagic disease of the newborn.
(b) There is accumulated evidence that the indiscriminate administration of mineral oil to infants may be followed by aspiration of the mineral oil and subsequent “lipoid pneumonia.”
(c) In view of these facts, the Department of Health and Human Services will regard as misbranded under the provisions of the Federal Food, Drug, and Cosmetic Act a drug for oral administration consisting in whole or in part of mineral oil, the labeling of which encourages its use in pregnancy or indicates or implies that such drug is for administration to infants.
(d) It is also this Department's view that the act requires the labelings of such drugs to bear a warning against consumption other than at bedtime and against administration to infants. The following form of warning is suggested: “Caution: To be taken only at bedtime. Do not use at any other time or administer to infants, except upon the advice of a physician.”
(e) This statement of interpretation does not in any way exempt mineral oil or preparations containing mineral oil from complying in all other respects with the requirements of the Federal Food, Drug, and Cosmetic Act.

Title 21 published on 2012-04-01

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.

  • 2012-05-11; vol. 77 # 92 - Friday, May 11, 2012
    1. 77 FR 27591 - Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Delay of Compliance Dates
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; delay of compliance dates; request for comments.
      Effective Date: This final rule is effective June 18, 2012. The final rule published at 76 FR 35620 on June 17, 2011, remains effective June 18, 2012. Comment date: Submit written or electronic comments on the delay of compliance dates by May 21, 2012. Compliance Dates: The compliance dates for the final rule published at 76 FR 35620 on June 17, 2011, including the lifting of the delay of implementation date for 21 CFR 201.66 as published at 69 FR 53801, September 3, 2004, are delayed until December 17, 2013, for products with annual sales of less than $25,000, and until December 17, 2012 for all other products subject to the rule.
      21 CFR Parts 201 and 310

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code
USC : Title 21 - FOOD AND DRUGS

§ 351 - Adulterated drugs and devices

§ 352 - Misbranded drugs and devices

§ 353 - Exemptions and consideration for certain drugs, devices, and biological products

§ 358 - Authority to designate official names

§ 360 - Registration of producers of drugs or devices

§ 360b - New animal drugs

§ 360ss - State standards

21 USC § 221 to 237 - Repealed. July 1, 1944, ch. 373, title XIII,

U.S.C. : Title 42 - THE PUBLIC HEALTH AND WELFARE

§ 216 - Regulations

§ 241 - Research and investigations generally

Title 21 published on 2012-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 201 after this date.

  • 2013-02-06; vol. 78 # 25 - Wednesday, February 6, 2013
    1. 78 FR 8446 - Center for Drug Evaluation and Research; Prescription Drug Labeling Improvement and Enhancement Initiative; Request for Comments and Information
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notification of an initiative; request for comments and information.
      Submit either electronic or written comments by March 8, 2013.
      21 CFR Parts 201, 314, and 601