Sulfites are chemical substances that are added to certain drug products to inhibit the oxidation of the active drug ingredient. Oxidation of the active drug ingredient may result in instability and a loss of potency of the drug product. Examples of specific sulfites used to inhibit this oxidation process include sodium bisulfite, sodium metabisulfite, sodium sulfite, potassium bisulfite, and potassium metabisulfite. Recent studies have demonstrated that sulfites may cause allergic-type reactions in certain susceptible persons, especially asthmatics. The labeling for any prescription drug product to which sulfites have been added as an inactive ingredient, regardless of the amount added, must bear the warning specified in paragraph or of this section. The label of a prescription or insulin-containing drug in package form shall bear a declaration of the net quantity of contents.

This exemption shall not apply to any substance intended for a use which results in the preparation of a new drug, unless an approved new-drug application provides for such use. If it is intended for administration by parenteral injection, the quantity or proportion of all inactive ingredients, except that ingredients added to adjust the pH or to make the drug isotonic may be declared by name and a statement of their effect; and if the vehicle is water for injection, it need not be named. When prescription drug labeling must summarize or otherwise rely on a recommendation by an authoritative scientific body, or on a standardized methodology, scale, or technique, because the information is important to prescribing decisions, the labeling may include a reference to the source of the information. Recommended general treatment procedures and specific measures for support of vital functions, such as proven antidotes, gastric lavage, and forced diuresis. Unqualified recommendations for which data are lacking with the specific drug or class of drugs, especially treatment using another drug may not be stated unless specific data or scientific rationale exists to support safe and effective use. This section of the labeling shall list the adverse reactions that occur with the drug and with drugs in the same pharmacologically active and chemically related class, if applicable.

Until the term is more precisely defined by legislation or formal regulation, where the exact meaning of the term is significant, manufacturers should qualify any reference to “infant” to indicate whether it refers to a child who is not more than 1 year of age, or a child not more harmful use of alcohol than 2 years of age. This section does not apply to biological drug products that are subject to the requirements of section 351 of the Public Health Service Act, 42 U.S.C. 262. The statement of the place of business shall include the street address, city, State, and ZIP Code.

Labeling Information | Drug Products

There is reason to believe that the drug product would represent a meaningful therapeutic benefit over existing treatments for pediatric patients for one or more of the claimed indications, and the absence of adequate labeling could pose significant risks to pediatric patients. Requirements on content and format of labeling for human prescription drug and biological products. is alcoholism genetic or hereditary Of the total number of subjects in clinical studies of , __ percent were 65 and over, while __ percent were 75 and over. The information described under this heading is not required for drugs approved for use only during labor and delivery. Indications or uses must not be implied or suggested in other sections of the labeling if not included in this section.

If safety considerations are such that the drug should be reserved for certain situations, e.g., cases refractory to other drugs, this information shall be stated in this section. Paragraph of this section shall apply except that the letter height or type size for the title “Drug Facts ” shall be no smaller than 7-point type and the headings in paragraphs through of this section shall be the larger of either 7-point or greater type, or 1-point size greater than the point size of the text. Graphical images (e.g., the UPC symbol) and information not described in paragraphs through of this section shall not appear in or in any way interrupt the required title, headings, subheadings, and information in paragraphs through of this section. The phenylalanine/aspartame content required by § 201.21, if applicable, shall appear as the next item of information.

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Recommended general treatment procedures and specific measures for support of vital functions (e.g., proven antidotes, gastric lavage, forced diuresis, or as per Poison Control Center). Such recommendations must be based on data available for the specific drug or experience with pharmacologically related drugs. Unqualified recommendations for which data are lacking for the specific drug or class of drugs must not be stated. If specific pharmacokinetic or pharmacodynamic studies have been carried out in the elderly, they must be described briefly in the “Geriatric use” subsection and in detail under the “Clinical Pharmacology” section. The “Clinical Pharmacology” and “Drug Interactions” sections ordinarily contain information on drug/disease and drug/drug interactions that is particularly relevant to the elderly, who are more likely to have concomitant illness and to use concomitant drugs.

• Under the subheading “Data,” the labeling must describe the data that are the basis for the Risk Summary and Clinical Considerations.
• Each drug manufacturer or authorized distributor of record that distributes drug samples by means of representatives shall conduct, at least annually, a complete and accurate physical inventory of all drug samples.
• Such inert glandular materials for parenteral use are therefore subject to the same comment as applies to those intended for oral administration.
• The regulations affecting special dietary foods (§ 105.3 of this chapter) define an infant as a child not more than 12 months old.
• A statement of liquid measure of the contents shall in the case of prescription drugs be expressed in terms of the U.S. gallon of 231 cubic inches and quart, pint, fluid-ounce, and fluid-dram subdivisions thereof, or of the liter and milliliter, or cubic centimeter, and shall express the volume at 68 °F.

It should be mounted as close as possible to the input optics of the spectrometer to maximize capture of forward scattered radiation. The sample holder should be a thin, flat plate with a suitable aperture through which UV radiation can pass. The PMMA plate should be placed on the upper surface of the sample holder with the roughened side facing up.

FDA Regulation of Animal Drugs

Sections or subsections of labeling that are identified as containing recent major changes under paragraph of this section must be highlighted in the full prescribing information by the inclusion of a vertical line on the left edge of the new or modified text. The labeling information required by paragraphs through , through , and of this section must be in bold print. Any discussion of a clinical study that relates to a risk from the use of the drug must also refer to the other sections of the labeling where the risk is identified or discussed. Additional subsections may be included, as appropriate, if sufficient data are available concerning the use of the drug in other specified subpopulations (e.g., renal or hepatic impairment).

The need to seek medical attention before again using tampons if TSS warning signs have occurred in the past, or if women have any questions about TSS or tampon use. Compatibility and minimum operating requirements for the software device. Information on the function of all controls intended for user adjustment.

A recipient charitable institution shall store drug samples under conditions that will maintain the sample’s stability, integrity, and effectiveness, and will ensure that the drug samples will be free of contamination, deterioration, and adulteration. A drug sample donated by a licensed practitioner or donating charitable institution shall be received by a charitable institution in its original, unopened packaging with its labeling intact. Inventory and reconciliation of drug samples of manufacturers’ and distributors’ representatives. Each drug manufacturer or authorized distributor of record that distributes drug samples by means of representatives shall conduct, at least annually, a complete and accurate physical inventory of all drug samples. All drug samples in the possession or control of each manufacturer’s and distributor’s representatives are required to be inventoried and the results of the inventory are required to be recorded in an inventory record, as specified in paragraph of this section.

Requirements for Labeling On Manufactured Prescription Animal Drugs

A dispenser is any person, as defined in section 201 of the Federal Food, Drug, and Cosmetic Act, engaged in the sale of hearing aids to any member of the consuming public or any employee, agent, salesperson, and/or representative of such a person. To generate ozone at a level less than 0.05 part per million by volume of air circulating through the device and it is labeled for use as a germicide transitional and sober living house in boston, ma or deodorizer. Copies of invoice, shipping document, and records of sale or distribution of all impact resistant lenses, including finished eyeglasses and sunglasses, shall be kept and maintained for a period of 3 years; however, the names and addresses of individuals purchasing nonprescription eyeglasses and sunglasses at the retail level need not be kept and maintained by the retailer.

Provided, however, That the information referred to in paragraph of this section may be contained in the labeling on or within the package from which it is to be dispensed. All labeling, except labels and cartons, bearing information for use of the drug also bears the date of the issuance or the date of the latest revision of such labeling. If there is a common belief that the drug may be effective for a certain use or if there is a common use of the drug for a condition, but the preponderance of evidence related to the use or condition shows that the drug is ineffective, the Food and Drug Administration may require that the labeling state that there is a lack of evidence that the drug is effective for that use or condition.

The labeling must describe available intervention for monitoring or mitigating the adverse reaction presented in the Risk Summary. Human and animal data must be presented separately, beneath the headings “Human Data” and “Animal Data,” and human data must be presented first. Radiation dosimetry information must be stated for both the patient receiving a radioactive drug and the person administering it.

Color additives may be designated as coloring without naming specific color components unless the naming of such components is required by a color additive regulation prescribed in subchapter A of this chapter. The drug, if used for a particular indication only in conjuction with a primary mode of therapy, e.g., diet, surgery, or some other drug, is an adjunct to the mode of therapy. If appropriate, other important chemical or physical information, such as physical constants, or pH, shall be stated.

Delivery of a donated drug sample to a recipient charitable institution shall be completed by mail or common carrier, collection by an authorized agent or employee of the recipient charitable institution, or personal delivery by a licensed practitioner or an agent or employee of the donating charitable institution. Donated drug samples shall be placed by the donor in a sealed carton for delivery to or collection by the recipient charitable institution. A manufacturer or authorized distributor of record that distributes drug samples shall inform FDA in writing within 30 days of selecting the individual responsible for responding to a request for information about drug samples of that individual’s name, business address, and telephone number.