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C If specific tests are necessary for selection or monitoring of the patients who need the drug e. D If information on limitations of use or uncertainty about anticipated clinical benefits is relevant to the recommended intervals between doses, to the appropriate duration of treatment when such treatment should be limited, or to any modification of dosage, a concise description of the information with reference to the more detailed information in the "Dosage and Administration" section.

E If safety considerations are such that the drug should be reserved for specific situations e. F If there are specific conditions that should be met before the drug is used on a long term basis e. For biological products, such statements must be supported by substantial evidence. Indications or uses must not be implied or suggested in other sections of the labeling if not included in this section.

B An upper limit beyond which safety and effectiveness have not been established, or beyond which increasing the dose does not result in increasing effectiveness,. G Dosing recommendations based on clinical pharmacologic data e. H Modification of dosage needed because of drug interactions or in special patient populations e. J Efficacious or toxic concentration ranges and therapeutic concentration windows of the drug or its metabolites, if established and clinically significant.

Information on therapeutic drug concentration monitoring TDM must also be included in this section when TDM is necessary. This section must contain information on the available dosage forms to which the labeling applies and for which the manufacturer or distributor is responsible, including:.

The National Drug Code number s for the drug product must not be included in this section. This section must describe any situations in which the drug should not be used because the risk of use e. Those situations include use of the drug in patients who, because of their particular age, sex, concomitant therapy, disease state, or other condition, have a substantial risk of being harmed by the drug and for whom no potential benefit makes the risk acceptable.

Known hazards and not theoretical possibilities must be listed e. If no contraindications are known, this section must state "None. The frequency of all clinically significant adverse reactions and the approximate mortality and morbidity rates for patients experiencing the reaction, if known and necessary for the safe and effective use of the drug, must be expressed as provided under paragraph c 7 of this section. In accordance with A specific warning relating to a use not provided for under the "Indications and Usage" section may be required by FDA in accordance with sections n and a of the act if the drug is commonly prescribed for a disease or condition and such usage is associated with a clinically significant risk or hazard.

This section must contain information regarding any special care to be exercised by the practitioner for safe and effective use of the drug e. This section must identify any laboratory tests helpful in following the patient's response or in identifying possible adverse reactions. If appropriate, information must be provided on such factors as the range of normal and abnormal values expected in the particular situation and the recommended frequency with which tests should be performed before, during, and after therapy.

This section must briefly note information on any known interference by the product with laboratory tests and reference the section where the detailed information is presented e.

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This section must describe the overall adverse reaction profile of the drug based on the entire safety database. For purposes of prescription drug labeling, an adverse reaction is an undesirable effect, reasonably associated with use of a drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. This definition does not include all adverse events observed during use of a drug, only those adverse events for which there is some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event.


This section must list the adverse reactions that occur with the drug and with drugs in the same pharmacologically active and chemically related class, if applicable. The list or lists must be preceded by the information necessary to interpret the adverse reactions e.

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Within a listing, adverse reactions must be categorized by body system, by severity of the reaction, or in order of decreasing frequency, or by a combination of these, as appropriate. Within a category, adverse reactions must be listed in decreasing order of frequency. If frequency information cannot be reliably determined, adverse reactions must be listed in decreasing order of severity. A Clinical trials experience. This section must list the adverse reactions identified in clinical trials that occurred at or above a specified rate appropriate to the safety database.

The rate of occurrence of an adverse reaction for the drug and comparators e.

If adverse reactions that occurred below the specified rate are included, they must be included in a separate listing. If comparative rates of occurrence cannot be reliably determined e. For adverse reactions with significant clinical implications, the listings must be supplemented with additional detail about the nature, frequency, and severity of the adverse reaction and the relationship of the adverse reaction to drug dose and demographic characteristics, if data are available and important.

B Postmarketing experience.

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This section of the labeling must list the adverse reactions, as defined in paragraph c 7 of this section, that are identified from domestic and foreign spontaneous reports. This listing must be separate from the listing of adverse reactions identified in clinical trials. For drug products other than biological products, any claim comparing the drug to which the labeling applies with other drugs in terms of frequency, severity, or character of adverse reactions must be based on adequate and well-controlled studies as defined in For biological products, any such claim must be based on substantial evidence.

The mechanism s of the interaction, if known, must be briefly described. Interactions that are described in the "Contraindications" or "Warnings and Precautions" sections must be discussed in more detail under this section.

CFR - Code of Federal Regulations Title 21

Details of drug interaction pharmacokinetic studies that are included in the "Clinical Pharmacology" section that are pertinent to clinical use of the drug must not be repeated in this section. This subsection of the labeling must contain the following information in the following order under the subheadings "Pregnancy Exposure Registry," "Risk Summary," "Clinical Considerations," and "Data":.

A Pregnancy exposure registry. If there is a scientifically acceptable pregnancy exposure registry for the drug, contact information needed to enroll in the registry or to obtain information about the registry must be provided following the statement: "There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to name of drug during pregnancy. B Risk summary.

Non-medical use of prescription drugs #NonMedicalDrugs

When multiple data sources are available, the statements must be presented in the following order: Human, animal, pharmacologic. The source s of the data must be stated. The labeling must state the percentage range of live births in the United States with a major birth defect and the percentage range of pregnancies in the United States that end in miscarriage, regardless of drug exposure.

If such information is available for the population s for which the drug is labeled, it must also be included. When use of a drug is contraindicated during pregnancy, this information must be stated first in the Risk Summary. When applicable, risk statements as described in paragraphs c 9 i B 1 and 2 of this section must include a cross-reference to additional details in the relevant portion of the "Data" subheading in the "Pregnancy" subsection of the labeling.

If data demonstrate that a drug is not systemically absorbed following a particular route of administration, the Risk Summary must contain only the following statement: " Name of drug is not absorbed systemically following route of administration , and maternal use is not expected to result in fetal exposure to the drug. When human data are available that establish the presence or absence of any adverse developmental outcome s associated with maternal use of the drug, the Risk Summary must summarize the specific developmental outcome s ; their incidence; and the effects of dose, duration of exposure, and gestational timing of exposure.

If human data indicate that there is an increased risk for a specific adverse developmental outcome in infants born to women exposed to the drug during pregnancy, this risk must be quantitatively compared to the risk for the same outcome in infants born to women who were not exposed to the drug but who have the disease or condition for which the drug is indicated to be used.

When risk information is not available for women with the disease or condition for which the drug is indicated, the risk for the specific outcome must be compared to the rate at which the outcome occurs in the general population. The Risk Summary must state when there are no human data or when available human data do not establish the presence or absence of drug-associated risk. When animal data are available, the Risk Summary must summarize the findings in animals and based on these findings, describe, for the drug, the potential risk of any adverse developmental outcome s in humans.

This statement must include: The number and type s of species affected, timing of exposure, animal doses expressed in terms of human dose or exposure equivalents, and outcomes for pregnant animals and offspring. When animal studies do not meet current standards for nonclinical developmental toxicity studies, the Risk Summary must so state. When there are no animal data, the Risk Summary must so state. When the drug has a well-understood mechanism of action that may result in adverse developmental outcome s , the Risk Summary must explain the mechanism of action and the potential associated risks.

C Clinical considerations. If there are pharmacokinetic data that support dose adjustment s during pregnancy and the postpartum period, a summary of this information must be provided. If use of the drug is associated with a maternal adverse reaction that is unique to pregnancy or if a known adverse reaction occurs with increased frequency or severity in pregnant women, the labeling must describe the adverse reaction and available intervention s for monitoring or mitigating the reaction. The labeling must describe, if known, the effect of dose, timing, and duration of exposure on the risk to the pregnant woman of experiencing the adverse reaction.

If it is known or anticipated that treatment of the pregnant woman increases or may increase the risk of an adverse reaction in the fetus or neonate, the labeling must describe the adverse reaction, the potential severity and reversibility of the adverse reaction, and available intervention s for monitoring or mitigating the reaction.

The labeling must describe, if known, the effect of dose, timing, and duration of exposure on the risk. The information described under this heading is not required for drugs approved for use only during labor and delivery. D Data -- 1 "Data" subheading. Under the subheading "Data," the labeling must describe the data that are the basis for the Risk Summary and Clinical Considerations. Human and animal data must be presented separately, beneath the headings "Human Data" and "Animal Data," and human data must be presented first.

For human data, the labeling must describe adverse developmental outcomes, adverse reactions, and other adverse effects. To the extent applicable, the labeling must describe the types of studies or reports, number of subjects and the duration of each study, exposure information, and limitations of the data. Both positive and negative study findings must be included. For animal data, the labeling must describe the following: Types of studies, animal species, dose, duration and timing of exposure, study findings, presence or absence of maternal toxicity, and limitations of the data. Description of maternal and offspring findings must include dose-response and severity of adverse developmental outcomes.

Edit this record. Mark as duplicate. Find it on Scholar. Request removal from index. Revision history. From the Publisher via CrossRef no proxy journals. Configure custom resolver. Tony Crilly. Baltimore: Johns Hopkins University Press, Karen Hunger Parshall. Abeles - - Isis 98 3 Edited by, Paul Laxton. Introduction by, J. Denis Cosgrove.

Cormack - - Isis 96 1 Marcos Cueto. Randall M. Foreword by Charles E. You will not receive a reply. Skip to main content Skip to "About government". When is a DIN issued? What purpose does a DIN serve? Do DIN s only appear on prescription drugs? A DIN is assigned to all authorized prescription and over-the-counter drugs. Is there a significance or special meaning for the numbers in the DIN? Numbers are assigned randomly by a computer-generated system and have no particular meaning.

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