Code of Federal Regulations Title 21 Food and Drugs Parts 200 to 299, Revised as of April 1, 2022

THIS TITLE Title 21-FOOD AND DRUGS is composed of nine volumes. The parts in these volumes are arranged in the following order: Parts 1-99, 100-169, 170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300 to end. The first eight volumes, containing parts 1-1299, comprise Chapter I-Food and Drug Administration, Department of Health and Human Services. The ninth volume, containing part 1300 to end, includes Chapter II-Drug Enforcement Administration, Department of Justice, and Chapter III-Office of National Drug Control Policy. The contents of these volumes represent all current regulations codified under this title of the CFR as of April 1, 2022. Subpart A-General Provisions § 200.5 Mailing of important information about drugs. Manufacturers and distributors of drugs and the Food and Drug Administration occasionally are required to mail important information about drugs to physicians and others responsible for patient care. In the public interest, such mail should be distinctive in appearance so that it will be promptly recognized and read. The Food and Drug Administration will make such mailings in accordance with the specifications set forth in this section. Manufacturers and distributors of drugs are asked to make such mailings as prescribed by this section and not to use the distinctive envelopes for ordinary mail. (a) Use first class mail and No. 10 white envelopes. (b) The name and address of the agency or the drug manufacturer or distributor is to appear in the upper left corner of the envelope. (c) The following statements are to appear in the far left third of the envelope front, in the type and size indicated, centered in a rectangular space approximately 3 inches wide and 21⁄4 inches high with an approximately 3⁄8 inch-wide border in the color indicated: (1) When the information concerns a significant hazard to health, the statement: IMPORTANT DRUG WARNING The statement shall be in three lines, all capitals, and centered. 'Important' shall be in 36 point Gothic Bold type. 'Drug' and 'Warning' shall be in 36 point Gothic Condensed type. The rectangle’s border and the statement therein shall be red. (2) When the information concerns important changes in drug package labeling, the statement: IMPORTANT PRESCRIBING INFORMATION The statement shall be in three lines, all capitals, and centered. 'Important' shall be in 36 point Gothic Bold type. 'Prescribing' and 'Information' shall be in 36 point Gothic Condensed type. The rectangle’s border and the statement therein shall be blue. (3) When the information concerns a correction of prescription drug advertising or labeling, the statement: IMPORTANT CORRECTION OF DRUG INFORMATION The statement shall be in four lines, all capitals, and centered. 'Important' shall be in 36 point Gothic Bold type. 'Correction,' 'Of Drug,' and 'Information' shall be in 36 point Gothic Condensed type. The rectangle’s border and the statement therein shall be brown. § 200.7 Supplying pharmacists with indications and dosage information. There are presently no regulations under the Federal Food, Drug, and Cosmetic Act that prevent a manufacturer of prescription drugs from sending the pharmacist data he needs on indications and dosage in exercising his important professional function of checking against possible mistakes in a prescription. The Food and Drug Administration believes manufacturers should be encouraged to supply such printed matter to the pharmacist for his professional information. Obviously, such printed matter should not be displayed to prospective purchasers to promote over-the-counter sale of prescription drugs