21 CFR 201.72 - Potassium labeling. | Title 21 - Food and Drugs | Code of Federal Regulations

§ 201.72

Potassium labeling.

(a) The labeling of over-the-counter (OTC) drug products intended for oral ingestion shall contain the potassium content per dosage unit (e.g., tablet, teaspoonful) if the potassium content of a single maximum recommended dose of the product (which may be one or more dosage units) is 5 milligrams or more. OTC drug products intended for oral ingestion include gum and lozenge dosage forms, but do not include dentifrices, mouthwashes, or mouth rinses.

(b) The potassium content shall be expressed in milligrams or grams per dosage unit and shall include the total amount of potassium regardless of the source, i.e., from both active and inactive ingredients. If the dosage unit contains less than 1 gram of potassium, milligrams should be used. The potassium content shall be rounded-off to the nearest 5 milligrams (or nearest tenth of a gram if over 1 gram). The potassium content per dosage unit shall follow the heading “Other information” as stated in § 201.66(c)(7).

(c) The labeling of OTC drug products intended for oral ingestion shall contain the following statement under the heading “Warning” (or “Warnings” if it appears with additional warning statements) if the amount of potassium present in the labeled maximum daily dose of the product is more than 975 milligrams: “Ask a doctor before use if you have [in bold type] [bullet] 1 kidney disease [bullet] a potassium-restricted diet”. The warnings in §§ 201.64(c), 201.70(c), 201.71(c), and 201.72(c) may be combined, if applicable, provided the ingredients are listed in alphabetical order, e.g., a magnesium or potassium-restricted diet.

Footnote(s): 1 See § 201.66(b)(4) of this chapter for definition of bullet symbol.

(d) Any product subject to this paragraph that is not labeled as required by this paragraph and that is initially introduced or initially delivered for introduction into interstate commerce after the following dates is misbranded under sections 201(n) and 502(a) and (f) of the Federal Food, Drug, and Cosmetic Act.

(1) As of the date of approval of the application for any single entity and combination products subject to drug marketing applications approved on or after April 23, 2004.

(2) September 24, 2005, for all OTC drug products subject to any OTC drug monograph, not yet the subject of any OTC drug monograph, or subject to drug marketing applications approved before April 23, 2004.

[69 FR 13734, Mar. 24, 2004]

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

77 FR 27591 - Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Delay of Compliance Dates

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-11390
RIN	0910-AF43
Docket No.	FDA-1978-N-0018

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

Summary

The Food and Drug Administration (FDA) is delaying the compliance dates for the final rule for over-the-counter (OTC) sunscreen drug products that published in the Federal Register of June 17, 2011 (76 FR 35620). The final rule establishes labeling and effectiveness testing for certain OTC sunscreen products containing specified active ingredients and marketed without approved applications. It also amends labeling claims that are not currently supported by data and lifts the previously-published delay of implementation of the Drug Facts labeling requirements for OTC sunscreens. The 2011 final rule's compliance dates are being delayed because information received after publication of the 2011 final rule indicates that full implementation of the 2011 final rule's requirements for all affected products will require an additional 6 months. This final rule is part of FDA's ongoing review of OTC drug products.

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

78 FR 8446 - Center for Drug Evaluation and Research; Prescription Drug Labeling Improvement and Enhancement Initiative; Request for Comments and Information

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-02528
RIN
Docket No.	FDA-2013-N-0059

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

Summary

The Food and Drug Administration (FDA) is announcing the establishment of a docket to receive comments on the proposed implementation of FDA's Prescription Drug Labeling Improvement and Enhancement Initiative and on a proposed pilot project relating to the voluntary conversion of labeling to the “Physician Labeling Rule (PLR)” format described in the 2006 FDA final rule, “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products.” The purpose of the initiative and the pilot project is to enhance the safe and effective use of prescription drugs by facilitating optimal communication through labeling. FDA is seeking public comment on this initiative, and the pilot project, particularly from stakeholders who develop and use prescription drug labeling. Comments received from stakeholders will assist the Agency in identifying and addressing feasibility and implementation issues associated with this initiative.

2012-05-11; vol. 77 # 92 - Friday, May 11, 2012

77 FR 27591 - Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Delay of Compliance Dates

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2012-11390
RIN	0910-AF43
Docket No.	FDA-1978-N-0018

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

Summary

The Food and Drug Administration (FDA) is delaying the compliance dates for the final rule for over-the-counter (OTC) sunscreen drug products that published in the Federal Register of June 17, 2011 (76 FR 35620). The final rule establishes labeling and effectiveness testing for certain OTC sunscreen products containing specified active ingredients and marketed without approved applications. It also amends labeling claims that are not currently supported by data and lifts the previously-published delay of implementation of the Drug Facts labeling requirements for OTC sunscreens. The 2011 final rule's compliance dates are being delayed because information received after publication of the 2011 final rule indicates that full implementation of the 2011 final rule's requirements for all affected products will require an additional 6 months. This final rule is part of FDA's ongoing review of OTC drug products.

21 CFR 201.72 - Potassium labeling.

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