Regulatory History for Ipecac Syrup

In the following sections of the background package, we have included Federal Register documents related to the development of the rulemakings for poison treatment drug products for over-the-counter human use. This provides a frame of reference for the information available in the public record and the rationale behind past decisions. The table below describes what is included in the documents and in some cases the locations that are most relevant to the issues for discussion on June 12, 2003. This will allow you to decide what is important to read and what is not in your assessment of the issues. We wish to focus the June 12th meeting on the regulatory status of ipecac syrup, i.e., whether it should remain OTC or be moved to Rx status.

The OTC drug monograph process can be divided into 4 steps:

1. Advisory Review Panel - Panel reviews information submitted to the FDA

2. Advance Notice of Proposed Rulemaking (ANPR) - Published recommendations of Panel

3. Tentative Final Monograph (TFM) or Proposed Rule - FDA proposal for monograph

4. Final Rule - Final regulation that describes the conditions of use for ingredients in the drug category

The monograph for OTC poison treatment drug products is at the TFM or Proposed Rule stage. It currently proposes that the ingredients ipecac syrup and activated charcoal are safe and effective for the treatment of poisonings. The FDA is in the process of writing a final rule. Your recommendations regarding whether ipecac syrup should remain OTC or be moved to Rx status will be considered as the final rule is being written.

Section

Federal Register Notice

Information in Notice
 

October 27, 1965

Statement of General Policy or Interpretation:

Ipecac Syrup in One Fluid Ounce Containers; Required Warnings and Directions

This section - Ipecac syrup; warnings and directions for use for over-the-counter sale - was added as a new regulation in 1965. This section is now codified at 21 CFR 201.308.
 

March 21, 1975 (40 FR 12902)

Establishment of Monographs for OTC Laxative, Antidiarrheal, Emetic and Antiemetic Products (Panel Report or ANPR)

This rulemaking contains the recommendations of the Advisory Review Panel on OTC Laxative, Antidiarrheal, Emetic, and Antiemetic Drug Products (the LAEA Panel). The LAEA Panel classified ipecac syrup as a Category I (safe and effective) emetic.

  • page 12939: Under Emetics, discussion of ipecac syrup safety and effectiveness
  • page 12944: Under Emetics, labeling for ipecac syrup
 

September 5, 1978 (43 FR 39544)

Tentative Final Order (TFM) for Emetic Drug Products for Over-the-Counter Human Use

 

This rulemaking is FDA's tentative conclusions on comments submitted in response to the 1975 Panel's report.

  • page 39545, comments 6-12 start discussion of safety and effectiveness of ipecac syrup
  • pages 39545 to 39546 summarize FDA's labeling for ipecac syrup, with proposed warnings and directions for use.
 

March 21, 1980 (45 FR 18398)

Acceptance of Data and Information Into the Administrative Record

In this notice, FDA reopened the administrative record for OTC laxative, antidiarrheal, emetic, and antiemtic drug products for data and information filed after the official close of the administrative record.

Table (con't)

Section

Federal Register Notice

Information in Notice
 

January 5, 1982 (47 FR 444)

Establishment of a Monograph for OTC Human Use for the Treatment of Acute Toxic Ingestion (Panel Report or ANPR)

This rulemaking contains the recommendations of the Advisory Review Panel on OTC Miscellaneous Internal Drug Products (the MI Panel). The MI Panel classified ipecac syrup and activated charcoal as safe and effective to treat acute toxic ingestion.

  • page 446 starts a general discussion for treatment of poisoning using ipecac syrup as an emetic and activated charcoal as an adsorbent.
  • page 447-448 continues a discussion on labeling
  • page 449-450 discusses ipecac syrup and a kit containing ipecac syrup and activated charcoal.
  • page 451 discusses the Panel's recommended labeling for ipecac syrup.
 

January 15, 1985 (50 FR 2244)

Poison Treatment Drug Products for Over-the-Counter Human Use: Tentative Final Monograph (TFM)

The comment period for the proposed rule on OTC poison treatment closed on May 15, 1985. FDA received comments from 6 poison control centers, 6 hospitals, 7 medical schools, 3 trade associations, 5 manufacturers, 3 law firms, and 14 individuals. FDA is currently in the process of writing a final rule.

This rulemaking contains FDA's tentative conclusions and proposed labeling on OTC poison treatment drug products. This TFM is based on the recommendations of both the LAEA and MI Panels and comments on those reports. Because of overlap between the Emetic TFM and the Acute Toxic Ingestion ANPR, the agency decided to combine both rulemakings and publish a single TFM for Poison Treatment Drug Products.

  • pages 2245-2255 discuss comments regarding safety, efficacy, dosage, warnings, etc., for ipecac syrup.
  • page 2259 begins the agency's recommendations for ipecac syrup, which include the following:
  • Labeling on the Principal Display Panel directs a consumer to call a poison control center for help before using ipecac syrup, if possible; contains instructions in a conspicuously boxed area which should be read when the product is purchased; also provides space for emergency phone numbers.
  • specific dosages were specified for adults and children 12 years and older, children 1- under 12 years, children 6 mo. to under 1 year. The adult dosage of ipecac syrup was increased from 15 mL to 30 mL.
  • ipecac not to be used for children under 6 months unless directed by a health professional.
  • directions include repeating dosage if vomiting does not occur within 30 minutes and to keep patient active and moving.
  • directions revised to provide for water or other clear liquids to be administered following ipecac; milk should not be given.
  • package size is limited to 30 milliliters.
  • warnings include not to be administered after certain kinds of poisons, e.g., petroleum distillates, corrosives, and hydrocarbons unless directed by a health professional.
  • page 2260-2262 contain FDA's proposed labeling including use of ipecac syrup in a kit with activated charcoal.