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product to remain on area for 10 min- hot water; then drying, using the hot utes but no longer. Wash area thor- cycle for at least 20 minutes." oughly with warm water and soap or (3) "Body Lice: Body lice and their shampoo. A fine-toothed comb or a spe- eggs are generally found in the seams cial lice/nit removing comb may be of clothing, particularly in the waistused to help remove dead lice or their line and armpit area. They move to the eggs (nits) from hair. A second treat- skin to feed, then return to the seams ment must be done in 7 to 10 days to of the clothing where they lay their kill any newly hatched lice."

eggs. Clothing worn and not laundered (3) For products formulated for use as a

before treatment should be disinfected shampoo. “Apply to affected area until by the same procedure as described for all the hair is thoroughly wet with

head lice, except that sealing clothing product. Allow product to remain on

in a plastic bag is not recommended for area for 10 minutes but no longer. Add

body lice because the nits (eggs) from sufficient warm water to form a lather

these lice can remain dormant for a peand shampoo as usual. Rinse thor

riod of up to 30 days." oughly. A fine-toothed comb or a special lice/nit removing comb may be Subpart H-Drug Products for the used to help remove dead lice or their

Control of Dandruff eggs (nits) from hair. A second treat

Seborrheic Dermatitis, and ment must be done in 7 to 10 days to

Psoriasis kill any newly hatched lice." (e) Other required statements.

SOURCE: 56 FR 63568, Dec. 4, 1991, unless (1) “Head Lice: Head lice live on the otherwise noted. scalp and lay small white eggs (nits) on the hair shaft close to the scalp. The

8358.701 Scope. nits are most easily found on the nape (a) An over-the-counter dandruff, of the neck or behind the ears. All per- seborrheic dermatitis, or psoriasis drug sonal headgear, scarfs, coats, and bed product in a form suitable for topical linen should be disinfected by machine application is generally recognized as washing in hot water and drying, using safe and effective and is not misthe hot cycle of a dryer for at least 20 branded if it meets each of the condiminutes. Personal articles of clothing tions in this subpart and each general or bedding that cannot be washed may condition established in $330.1 of this be dry-cleaned, sealed in a plastic bag chapter. for a period of about 2 weeks, or (b) References in this subpart to regsprayed with a product specifically de- ulatory sections of the Code of Federal signed for this purpose. Personal combs Regulations are to chapter I of title 21 and brushes may be disinfected by unless otherwise noted. soaking in hot water (above 130 ° F) for 5 to 10 minutes. Thorough vacuuming

8358.703 Definitions. of rooms inhabited by infected patients As used in this subpart: is recommended."

(a) Coal tar. The tar used for medici(2) Pubic (Crab) Lice: Pubic lice may nal purposes that is obtained as a bybe transmitted by sexual contact; product during the destructive distillatherefore, sexual partners should be tion of bituminous coal at temperatreated simultaneously to avoid re- tures in the range of 900 °C to 1,100 °C. infestation. The lice are very small and It may be further processed using eilook almost like brown or grey dots on ther extraction with alcohol and suitthe skin. Pubic lice usually cause in- able dispersing agents and maceration tense itching and lay small white eggs times or fractional distillation with or (nits) on the hair shaft generally close without the use of suitable organic solto the skin surface. In hairy individ- vents. uals, pubic lice may be present on the (b) Dandruff. A condition involving short hairs of the thighs and trunk, an increased rate of shedding of dead underarms, and occasionally on the epidermal cells of the scalp. beard and mustache. Underwear should (c) Psoriasis. A condition of the scalp be disinfected by machine washing in or body characterized by irritation,

itching, redness, and extreme excess shedding of dead epidermal cells.

(d) Seborrheic dermatitis. A condition of the scalp or body characterized by irritation, itching, redness, and excess shedding of dead epidermal cells.

(e) Selenium sulfide, micronized. Selenium sulfide that has been finely ground and that has a median particle size of approximately 5 micrometers (um), with not more than 0.1 percent of the particles greater than 15 um and not more than 0.1 percent of the particles less than 0.5 um.

(4) Salicylic acid, 1.8 to 3 percent. (5) Selenium sulfide, 1 percent.

(c) Active ingredients for the control of psoriasis. (1) Coal tar, 0.5 to 5 percent. When a coal tar solution, derivative, or fraction is used as the source of the coal tar, the labeling shall specify the identity and concentration of the coal tar source used and the concentration of the coal tar present in the final product.

(2) Salicylic acid, 1.8 to 3 percent.

(56 FR 63568, Dec. 4, 1991, as amended at 59 FR 4001, Jan. 28, 1994)

(56 FR 63568, Dec. 4, 1991, as amended at 59 FR 4001, Jan. 28, 1994]

8 358.720 Permitted combinations of

active ingredients. Salicylic acid identified in 8358.710(a) (4) may be combined with sulfur identified in $358.710(a)(6) provided each ingredient is present within the established concentration and the product is labeled for the control of dandruff.

or

8358.710 Active ingredients for the

control of dandruff, seborrheic der

matitis, or psoriasis. The active ingredient of the product consists of any of the following within the specified concentration established for each ingredient:

(a) Active ingredients for the control of dandruff. (1) Coal tar, 0.5 to 5 percent. When a coal tar solution, derivative, or fraction is used as the source of the coal tar, the labeling shall specify the identity and concentration of the coal tar source used and the concentration of the coal tar present in the final product.

(2) Pyrithione zinc, 0.3 to 2 percent when formulated to be applied and then washed off after brief exposure.

(3) Pyrithione zinc, 0.1 to 0.25 percent when formulated to be applied and left on the skin or scalp.

(4) Salicylic acid, 1.8 to 3 percent. (5) Selenium sulfide, 1 percent.

(6) Selenium sulfide, micronized, 0.6 percent.

(7) Sulfur, 2 to 5 percent.

(b) Active ingredients for the control of seborrheic dermatitis. (1) Coal tar, 0.5 to 5 percent. When a coal tar solution, derivative, or fraction is used as the source of the coal tar, the labeling shall specify the identity and concentration of the coal tar source used and the concentration of the coal tar present in the final product.

(2) Pyrithione zinc, 0.95 to 2 percent when formulated to be applied and then washed off after brief exposure.

(3) Pyrithione zinc, 0.1 to 0.25 percent when formulated to be applied and left on the skin or scalp.

$358.750 Labeling of drug products for

the control of dandruff, seborrheic

dermatitis, or psoriasis. (a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product with one or more of the following, as appropriate: (1) “Dandruff (insert product form)"

"antidandruff (insert product form)”.

(2) “Seborrheic dermatitis (insert product form)”.

(3) “Psoriasis (insert product form)”.

(b) Indications. The labeling of the product states, under the heading "Indications,” the phrase listed in paragraph (b)(1) of this section and may contain any of the terms listed in paragraph (b)(2) or (b)(3) of this section. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in paragraph (b) of this section, may also be used, as provided in $330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(1) (For relief of” or “Controls”) “the symptoms of"' (select one or more of the following, as appropriate: “dandruff," "seborrheic dermatitis," and/or “psoriasis.")

(2) The following terms or phrases may be used in place of or in addition to the words "For the relief of” or "Controls" in the indications in paragraph (b)(1) of this section: "fights," "reduces," "helps eliminate," "helps stop," "controls recurrence of," "fights recurrence of," "helps prevent recurrence of," "reduces recurrence of," "helps eliminate recurrence of," "helps stop recurrence of."

(3) The following terms may be used in place of the words “the symptoms of' in the indications in paragraph (b)(1) of this section: ("skin" and/or "scalp," as appropriate) (select one or more of the following: "itching," "irritation," "sredness," "flaking, "scaling,'') “associated with."

(c) Warnings. The labeling of the product contains the following warnings under the heading "Warnings":

(1) For products containing any ingredient identified in 9 358.710. (1) “For external use only."

(ii) “Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

(iii) “If condition worsens or does not improve after regular use of this product as directed, consult a doctor.

(2). For any product containing coal tar identified in $ 358.710(a), (b), of (c). (1) "Use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application."

(ii) “Do not use for prolonged periods without consulting a doctor."

(3) For products containing coal tar when formulated to be applied and left on the skin (e.g., creams, ointments, lotions). “Do not use this product in or around the rectum or in the genital area or groin except on the advice of a doctor."

(4) For products containing coal tar identified in 8 358.710(C) for the control of psoriasis. Do not use this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor."

(5) For products containing any ingredient identified in $ 358.710(0) or (c) for the

control of seborrheic dermatitis of psoriasis. “If condition covers a large area of the body, consult your doctor before using this product."

(d) Directions. The labeling of the product contains the following information under the heading "Directions.” More detailed directions applicable to a particular product formulation may also be included.

(1) For products containing active ingredients for the control of dandruff, seborrheic dermatitis, or psoriasis when formulated to be applied and then washed off after brief (a few minutes) exposure (e.g, shampoos, preshampoo rinses, postshampoo rinses). "For best results use at least twice a week or as directed by a doctor."

(2) For products containing active ingredients for the control of dandruff, seborrheic dermatitis, of psoriasis when formulated so as to be applied and left on the skin or scalp (e.g., creams, ointments, lotions, hairgrooms). Apply to affected areas one to four times daily or as directed by a doctor."

(3) For products containing active ingredients for the control of seborrheic dermatitis or psoriasis of the skin when formulated as soaps. “Use on affected areas in place of your regular soap."

(e) The word “physician” may be substituted for the word “doctor" in any of the labeling statements in this section.

PART 361-PRESCRIPTION DRUGS

FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH

AUTHORITY: 21 U.S.C. 321, 351, 352, 353, 355, 371; 42 U.S.C. 262.

8361.1 Radioactive drugs for certain

research uses.

(a) Radioactive drugs (as defined in $310.3(n) of this chapter) are generally recognized as safe and effective when administered, under the conditions set forth in paragraph (b) of this section, to human research subjects during the course of a research project intended to obtain basic information regarding the metabolism (including kinetics, distribution, and localization) of a radioactively labeled drug or regarding human physiology, pathophysiology, or biochemistry, but not intended for immediate therapeutic,

therapeutic, diagnostic, or similar purposes or to determine the safety and effectiveness of the drug in humans for such purposes (i.e., to carry out a clinical trial). Certain basic research studies, e.g., studies to determine whether a drug localizes in a particular organ or fluid space and to describe the kinetics of that localization, may have eventual therapeutic or diagnostic implications, but the initial studies are considered to be basic research within the meaning of this section.

(b) The conditions under which use of radioactive drugs for research are considered safe and effective are:

(1) Approval by Radioactive Drug Research Committee. A Radioactive Drug Research Committee, composed and approved by the Food and Drug Administration in accordance with paragraph (c) of this section, has determined, in accordance with the standards set forth in paragraph (d) of this section, that:

(i) The pharmacological dose is within the limits set forth in paragraph (b)(2) of this section;

(ii) The radiation dose is within the limits set forth in paragraph (b)(3) of this section;

(iii) The radiation exposure is justified by the quality of the study being undertaken and the importance of the information it seeks to obtain;

(iv) The study meets the other requirements set forth in paragraph (d) of this section regarding qualifications of the investigator, proper licensure for handling radioactive materials, selection and consent of research subjects, quality of radioactive drugs used, research protocol design, reporting of adverse reactions, and approval by an appropriate Institutional Review Committee; and

(v) The use of the radioactive drug in human subjects has the approval of the Radioactive Drug Research Committee.

(2) Limit on pharmacological dose. The amount of active ingredient or combination of active ingredients to be administered shall be known not to cause

any clinically detectable pharmacological effect in human beings. If the same active ingredients (exclusive of the radionuclide) are to be administered simultaneously, e.g., under a “Investigational New Drug Application" or for a therapeutic use in accordance with labeling for a drug approved under part 314 of this chapter, the total amount of active ingredients including the radionuclide shall be known not to exceed the dose limitations applicable to the separate administration of the active ingredients excluding the radionuclide.

(3) Limit on radiation dose. The amount of radioactive material to be administered shall be such that the subject receives the smallest radiation dose with which it is practical to perform the study without jeopardizing the benefits to be obtained from the study.

(i) Under no circumstances may the radiation dose to an adult research subject from a single study or cumulatively from a number of studies conducted within 1 year be generally recognized as safe if such dose exceeds the following: Whole body, active blood-forming organs, lens of the eye, and gonads:

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(ii) For a research subject under 18 years of age at his last birthday, the radiation dose shall not exceed 10 percent of that set forth in paragraph (b)(3)(i) of this section.

(iii) All radioactive material included in the drug either as essential material or as a significant contaminant or impurity shall be included when determining the total radiation doses and dose commitments. Radiation doses from x-ray procedures that are part of the research study (i.e., would not have occurred but for the study) shall also be included. The possibility of followup studies shall be considered for inclusion in the dose calculations.

(iv) Numerical definitions of dose shall be based on an absorbed fraction method of radiation absorbed dose calculation, such as the system set forth by the Medical Internal Radiation Dose Committee of the Society of Nuclear Medicine, or the system set forth by the International Commission on Radiological Protection.

(c) A Radioactive Drug Research Committee, in order to comply with paragraph (b)(1) of this section, shall be composed, shall function, and shall obtain and maintain approval of the Food and Drug Administration in conformity with the following:

(1) Membership. A Radioactive Drug Research Committee shall consist of at least five individuals. Each committee shall include the following three individuals: (i) A physician recognized as a specialist in nuclear medicine, (ii) a person qualified by training and experience to formulate radioactive drugs, and (iii) a person with special competence in radiation safety and radiation dosimetry. The remainder of the committee shall consist of individuals qualified in various disciplines pertinent to the field of nuclear medicine (e.g., radiology, internal medicine, clinical pathology, hematology, endocrinology, radiation therapy, radiation physics, radiation biophysics, health physics, and radiopharmacy). Membership shall be sufficiently diverse to permit expert review of the technical and scientific aspects of proposals submitted to the committee. The addition of consultants in other pertinent medical disciplines is encouraged. A Radioactive Drug Research Committee shall be either associated with a medical institution operated for care of patients and with sufficient scientific expertise to allow for selection of committee members from its faculty, or with a committee established by a State authority to provide advice on radiation health matters. Joint committees involving more than one medical institution which have been established in order to achieve a high level and diversity of experience will be acceptable. The Director of the Center for Drug Evaluation and Research may modify any of the foregoing requirements in a particular situation where alternative factors provide substantially the same composition and association.

(2) Function. Each Radioactive Drug Research Committee shall select a chairman, who shall sign all applications, minutes, and reports of the committee. Each committee shall meet at least once each quarter in which research activity has been authorized or conducted. A quorum consisting of more than 50 percent of the membership must be present with appropriate representation of the required fields of specialization. Minutes shall be kept and shall include the numerical results of votes on protocols involving use in human subjects. No member shall vote on a protocol in which he is an investigator.

(3) Reports. Each Radioactive Drug Research Committee shall submit an annual report on or before January 31 of each year to the Food and Drug Administration, Center for Drug Evaluation and Research, HFD-160, 5600 Fishers Lane, Rockville, MD 20857. The annual report shall include the names and qualifications of the members of, and of any consultants used by, the Radioactive Drug Research Committee, and, for each study conducted during the preceding year, a summary of information presented in the following format:

REPORT ON RESEARCH USE OF RADIOACTIVE

DRUG

1. Title of the research project.

2. Brief description of the purpose of the research project.

3. Name of the investigator responsible.
4. Pharmacological dose:
a. Active ingredients.

b. Maximum amount administered per subject.

5. Name of the radionuclide(s) used, including any present, as significant contaminants or impurities.

6. Radiation absorbed dose. Provide the maximum dose commitement to the whole body and each organ specified in 21 CFR 361.1(b)(3)(1) that was received by a representative subject and the calculations or references that were used to estimate these maximum dose commitments. The report shall include the dose contribution of both the administered radionuclide(s) and any Xray procedures associated with the study. If the study elicits data on the uptake or excretion of the radioactive drug pertinent to the estimation of dose commitment, report the mean value and range of values. For each subject provide:

(a) Age, sex, and approximate weight.

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