SUBCHAPTER C—DRUGS: GENERAL PART 200—GENERAL use the distinctive envelopes for ordi- nary mail. Subpart A—General Provisions (a) Use first class mail and No. 10 white envelopes. Sec. 200.5 Mailing of important information (b) The name and address of the agen- about drugs. cy or the drug manufacturer or dis- 200.7 Supplying pharmacists with indica- tributor is to appear in the upper left tions and dosage information. corner of the envelope. 200.10 Contract facilities (including con- (c) The following statements are to sulting laboratories) utilized as extra- mural facilities by pharmaceutical man- appear in the far left third of the enve- ufacturers. lope front, in the type and size indi- 200.11 Use of octadecylamine in steam lines cated, centered in a rectangular space of drug establishments. approximately 3 inches wide and 21⁄4 200.15 Definition of term ‘‘insulin’’. inches high with an approximately 3⁄8 inch-wide border in the color indicated: Subpart B [Reserved] (1) When the information concerns a Subpart C—Requirements for Specific significant hazard to health, the state- Classes of Drugs ment: 200.50 Ophthalmic preparations and dis- IMPORTANT pensers. 200.51 Aqueous-based drug products for oral DRUG inhalation. WARNING Subpart D [Reserved] Subpart E—Prescription Drug Consumer The statement shall be in three lines, Price Listing all capitals, and centered. ‘‘Important’’ shall be in 36 point Gothic Bold type. 200.200 Prescription drugs; reminder adver- ‘‘Drug’’ and ‘‘Warning’’ shall be in 36 tisements and reminder labeling to pro- point Gothic Condensed type. The rec- vide price information to consumers. tangle’s border and the statement AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 353, therein shall be red. 355, 358, 360e, 371, 374, 375. (2) When the information concerns SOURCE: 40 FR 13996, Mar. 27, 1975, unless important changes in drug package la- otherwise noted. beling, the statement: Subpart A—General Provisions IMPORTANT § 200.5 Mailing of important informa- PRESCRIBING tion about drugs. Manufacturers and distributors of INFORMATION drugs and the Food and Drug Adminis- tration occasionally are required to The statement shall be in three lines, mail important information about all capitals, and centered. ‘‘Important’’ drugs to physicians and others respon- shall be in 36 point Gothic Bold type. sible for patient care. In the public in- ‘‘Prescribing’’ and ‘‘Information’’ shall terest, such mail should be distinctive be in 36 point Gothic Condensed type. in appearance so that it will be The rectangle’s border and the state- promptly recognized and read. The ment therein shall be blue. Food and Drug Administration will (3) When the information concerns a make such mailings in accordance with correction of prescription drug adver- the specifications set forth in this sec- tising or labeling, the statement: tion. Manufacturers and distributors of drugs are asked to make such mailings as prescribed by this section and not to 5 VerDate Mar<15>2010 08:48 May 17, 2010 Jkt 220068 PO 00000 Frm 00015 Fmt 8010 Sfmt 8010 Y:\SGML\220068.XXX 220068 wwoods2 on DSKDVH8Z91PROD with CFR § 200.7 21 CFR Ch. I (4–1–10 Edition) IMPORTANT tion (NDA) or to the sponsor of an In- vestigational New Drug (IND) Applica- CORRECTION tion, any information obtained during OF DRUG the inspection of an extramural facil- ity having a specific bearing on the INFORMATION compliance of the manufacturer’s, ap- plicant’s, or sponsor’s product with the The statement shall be in four lines, all Federal Food, Drug, and Cosmetic Act. capitals, and centered. ‘‘Important’’ The Food and Drug Administration’s shall be in 36 point Gothic Bold type. ‘‘Correction,’’ ‘‘Of Drug,’’ and ‘‘Infor- position is that by the acceptance of mation’’ shall be in 36 point Gothic such contract work, the extramural fa- Condensed type. The rectangle’s border cility authorizes such disclosures. and the statement therein shall be (d) The Food and Drug Administra- brown. tion does not consider results of valida- tion studies of analytical and assay § 200.7 Supplying pharmacists with in- methods and control procedures to be dications and dosage information. trade secrets that may be withheld There are presently no regulations from the drug manufacturer by the under the Federal Food, Drug, and Cos- contracted extramural facility. metic Act that prevent a manufacturer [40 FR 13996, Mar. 27, 1975, as amended at 55 of prescription drugs from sending the FR 11576, Mar. 29, 1990] pharmacist data he needs on indica- tions and dosage in exercising his im- § 200.11 Use of octadecylamine in portant professional function of check- steam lines of drug establishments. ing against possible mistakes in a pre- The Food and Drug Administration scription. The Food and Drug Adminis- will not object to the use of tration believes manufacturers should octadecylamine in steam lines where be encouraged to supply such printed the steam may be used for autoclaving matter to the pharmacist for his pro- surgical instruments and gauze if the fessional information. Obviously, such octadecylamine in the steam is not printed matter should not be displayed more than 2.4 parts per million. to prospective purchasers to promote over-the-counter sale of prescription § 200.15 Definition of term ‘‘insulin.’’ drugs. For purposes of sections 801 and 802 of § 200.10 Contract facilities (including the act and this title, the term insulin consulting laboratories) utilized as means the active principle of the pan- extramural facilities by pharma- creas that affects the metabolism of ceutical manufacturers. carbohydrates in the animal body and (a) Section 704(a) of the Federal which is of value in the treatment of Food, Drug, and Cosmetic Act specifi- diabetes mellitus. The term includes cally authorizes inspection of con- synthetic and biotechnologically de- sulting laboratories as well as any fac- rived products that are the same as, or tory, warehouse, or establishment in similar to, naturally occurring insulins which prescription drugs are manufac- in structure, use, and intended effect tured, processed, packed, or held. and are of value in the treatment of di- (b) The Food and Drug Administra- abetes mellitus. tion is aware that many manufacturers [63 FR 26698, May 13, 1998] of pharmaceutical products utilize ex- tramural independent contract facili- ties, such as testing laboratories, con- Subpart B [Reserved] tract packers or labelers, and custom grinders, and regards extramural facili- Subpart C—Requirements for ties as an extension of the manufactur- Specific Classes of Drugs er’s own facility. (c) The Food and Drug Administra- § 200.50 Ophthalmic preparations and tion reserves the right to disclose to dispensers. the pharmaceutical manufacturer, or (a)(1) Informed medical opinion is in to the applicant of a new drug applica- agreement that all preparations offered 6 VerDate Mar<15>2010 08:48 May 17, 2010 Jkt 220068 PO 00000 Frm 00016 Fmt 8010 Sfmt 8010 Y:\SGML\220068.XXX 220068 wwoods2 on DSKDVH8Z91PROD with CFR Food and Drug Administration, HHS § 200.200 or intended for ophthalmic use, includ- sterile. These articles, which are regu- ing preparations for cleansing the eyes, lated as drugs if packaged with the should be sterile. It is further evident drugs with which they are to be used, that such preparations purport to be of should be packaged so as to maintain such purity and quality as to be suit- sterility until the package is opened able for safe use in the eye. and be labeled, on or within the retail (2) The Food and Drug Administra- package, so as to afford adequate direc- tion concludes that all such prepara- tions and necessary warnings to mini- tions, if they are not sterile, fall below mize the hazard of injury resulting their professed standard of purity or from contamination during use. quality and may be unsafe. In a state- [40 FR 13996, Mar. 27, 1975, as amended at 47 ment of policy issued on September 1, FR 50455, Nov. 5, 1982] 1964, the Food and Drug Administra- tion ruled that liquid preparations of- § 200.51 Aqueous-based drug products fered or intended for ophthalmic use for oral inhalation. that are not sterile may be regarded as (a) All aqueous-based drug products adulterated within the meaning of sec- for oral inhalation must be manufac- tion 501(c) of the Federal Food, Drug, tured to be sterile. and Cosmetic Act (the act), and, fur- (b) Manufacturers must also comply ther, may be deemed misbranded with- with the requirements in § 211.113(b) of in the meaning of section 502(j) of the this chapter. act. This ruling is extended to affect all preparations for ophthalmic use. By [65 FR 34089, May 26, 2000] this regulation, this ruling is applica- ble to ophthalmic preparations that Subpart D [Reserved] are regulated as drugs. By the regula- tion in § 800.10 of this chapter, this rul- Subpart E—Prescription Drug ing is applicable to ophthalmic prep- Consumer Price Listing arations that are regulated as medical devices. § 200.200 Prescription drugs; reminder (3) The containers of ophthalmic advertisements and reminder label- preparations shall be sterile at the ing to provide price information to time of filling and closing, and the con- consumers. tainer or individual carton shall be so (a) Prescription drug reminder adver- sealed that the contents cannot be used tisements and reminder labeling in- without destroying the seal. The pack- tended to provide price information to aging and labeling of ophthalmic prep- consumers are exempt from the re- arations that are over-the-counter quirements of §§ 201 .100 and 202.1 of this drugs shall also comply with § 211.132 of chapter if all of the following condi- this chapter on tamper-resistant pack- tions are met: aging requirements.