13996 RULES AND REGULATIONS Title 21-Food and Drugs Old New Old New PART 200-GENERAL Section Section Section Section Subpart A--General Provislons CHAPTER I-FOOD AND DRUG ADMIN- 133.11 ---- 211.58 3.509 ----- 201.314 Sec. ISTRATION, DEPARTMENT OF HEALTH, 133.12 ---- 211.110 3.510 ----- 201.315 200.5 Mailing of important information EDUCATION, AND WELFARE 133.13 ---- 211.60 3.512 ----- 200.31 about drugs. 133.14 ---- 211.62 [Recodification Docket No. 9] 3.513 ----- 200.7 200.7 Supplying pharmacists with Indi- ---- 211.115 3.514 ----- 201.55 133.15 cations and dosage information. SUBCHAPTER C-DRUGS: GENERAL 133.100 ____ 225.1 3.515 ----- 201.160 con- --- 22520 200.10 Contract facilities (including 3.516 ----- 250.105 133.101 sulting laboratories) Utilized as Reorganization and Republication --- 225.30 3.518 ----- 201.161 133.102 extramural facilities by pharma- 133.103 --- 225.10 The Commissioner of Food and Drugs, 132.1 ----- 207.3 ceutical manufacturer=. 133.104 --- 225A2 for the purposes of establishing an 132.2 ----- 207.20 200.11 Use of octadecylamine in steam of informative reg- 132.3 ----- 207.21 133.105 --- 225.102 lines of drug establishments. orderly development 133.106 --- 225.40 ulations for the Food and Drug Admin- 132.4 ---- 207.22 200.15 Definition of term "Insulin." 132.5 ----- 207.25 133.107 --- 225.80 istration, furnishing ample room for ..... 200.18 Use of secondhand containers for 132.6 ----- 207.30 133.108 225.58 the shipment or storage of food expansion of such regulations in years 225.110 132.7 ----- 207.31 133.109 and animal feed. ahead, and providing the public and af- 132.8 ----- 207.35 133.110 --- 225.115 --- Subpart B-ManufacturnlProcedures Affecting fected industries with regulations that 132.9 ----- 207.37 133.200 226.1 Novi DrugStatus are easy to find, read, and understand, 132.10 ---- 207.26 133.201 --- 226.20 has initiated a recodification program for 132.11 ---- 207.39 133.202 --- 226.30 200.30 Sterilization of drugs by irradia- the Code of Fed- 132.31 ---- 207.40 133.203 --- 226.10 tion. Chapter I of Title 21 of --- eral Regulations. 132.51 ---- 207.65 133.204 226.2 200.31 Timed release dosage forms. 133.1 ----- 210.3 133.205 --- 226.102 This is the ninth document in a series Subpart C--Requirements for Specific Classes or 133.2 ----- 211.1 133.206 -.... 226A0 Drugs of recodification documents that will 133.3 ----- 211.20 133.207 -- 226.80 eventually include all regulations ad- 133.4 ---- 211.30 133.208 226.58 200.50 Ophthalmic preparations and dis- ministered by the Food and Drug Ad- 133.5 ----- 211.10 133.209 --- 226.110 pensers, ministration. 133.6 ------- 211.42 133.210 --- 226.115 Subpart D-Sutability of Specific Drug This recodiflcation document repre- 133.7 ----- 211.101 133.300 --- 229.25 Components re- 133.8 ----- 211.40 138.1 ----- 299.3 200.100 Use of on bile from condemned sents a reorganization of material ----- Subchapter C-Drugs that 133.9 211.55 138.2 299.20 livers from slaughtered animals maining in ---- has general applicability, rather than 133.10 211.80 in the manufacture of drugs. 200.101 Suprarenal glands from hog car- strictly human or animal use. In addi- ' The changes being made are nonsub- casses prior to final inspection, tion certain related sections under Parts stantive in nature and for this reason 1 and 3 have been redesignated as part notice and public procedure are not pre- AuTnoRITy: Sec. 701, 52 Stat. 1055; 21 of the revised Subchapter C-Drugs: requisites to this promulgation. For the U.S.C. 371, unless otherwise noted. General. convenience of the user, the entire text of Subpart A-General Provisions The following table shows the relation- Parts 200, 201, 202, 207, 210, 211, 225, 226, ship of the CFR section numbers inder 229, 250, 290, and 299 of Subehapter C § 200.5 Mailing of important inforniu- tion about drugs. the former Subchapters A and C to their is set forth below. redesignation reflected in the new Parts Manufacturers and distributors of Dated: March 21, 1975. 200 through 299: drugs and the Food and Drug Adminis- Old New Old New S A D. FINE, tration occasionally are required to mal Section Section Section Section Associate Commissioner for Important Information about drugs to 1.100 ----- 299.5 3.21 -------- 250.102 Compliance. physicians and others responsible for public interest, such 1.101 -----.- 201.6 3.22 -------- 200.101 Therefore, 21 CFR is amended by re- patient care. In the 1.101a ---- 201.60 3.27 -------- 250.203 mail should be distinctive In appearance of Parts 1 and 3 1.102 ----- 201.50 3.28 -------- 200.50 designating portions so that It will be prolnptly recognized and Parts 132, 133, and 1.102a ---- 201.61 3.29 -------- 201.307 of Subehapter A and read. The Food and Drug Administration 1.102b ---- 201.1 3.30 -------- 201.308 138 of Subchapter C as Parts 200, 201, will make such mailings In accordance 226, 229, 250, 290, 1.102c ------ 201.51 3.35 -------- 201.303 202, 207, 210, 211, 225, with the specifications set forth In this 1.102d ---- 201.62 3.36 -------- 250.103 and 299 of Subchapter C-Drugs: Gen- section. Manufacturers and distributors 1.103 ------ 201.15 3.37 -------- 201.309 eral, and republished to read as follows: 1.104 ----- 201.10 3.40 -------- 250.201 of drugs are asked to make such mailings 1.105 ---- 202.1 33.-------- 201.310 SUBCHAPTER C-DRUGS: GENERAL as prescribed by-this section and not to 1,106(a) --- 201.5 3.44 -------- 201.311 Part use the distinctive envelopes for ordinary --- 1.106(b) 201.100 3.45 -------- 200.30 200-General mall. 1.106(c) --- 201.105 3.48 -------- 250.106 (a) Use first class mail and No. 10 1.106(d) --- 201.109 3.50 -------- 250.104 201-Labeling white envelopes. ---- 1.106(f) 201.110 3.52 -------- 250.107 (b) The name and address of the 1.106(g) --- 201.115 3.53 -------- 250.10 202-Prescription Drug Advertising or dis- 1.106(h) - 201.116 3.56 -------- 201A05 207-Registration of Producers of Drugs and agency or the drug manufacturer 1.106(1) ---- 201.117 3.61 ------- 200.18 Listing of Drugs in Commercial DIs- tributor Is to appear In the upper left 1.106(J) ---- 201.119 3.62 -------- 2994 tribution corner of the envelope. 1.106(k) --- 201.120 3.63 -------- 250.11 (c) The following statements are to 1.106(1) ---- 201.122 3.64 -------- 250.12 210-Current Good Manufacturing Practices in Manufacturing, Processing, Pack- appear in the far left third of the en- 1.106(m) --- 201.125 3.67 -------- 201.305 ing, or Holding of Drugs: General velope front, in the type and size indi- - 1.106(n) 201.127 3.71 -------- 250.100 In a rectangular spabo 1.105(o) --- 201.128 3.74 -------- 201.56 cated, centered 211-Current Good Manufacturing Practice approximately 3 inches wide and 22/ 1.107 ----- 201.150 3.76 -------- 200.10 for Finished Pharmaceuticals 1.108(a) 3.77 -------- 290.35 Inches high with an approximately %- & (b) ---- 201.16 3.81 -------- 201.200 225--Current Good Manufacturing Practice Inch-wide border in the color indicated: 1.108(c) ---- 290.6 3.84 -------- 201.410 for Medicated Feeds (1) When the information concerns 1.109 ----- 290.5 3.90 -------- 250.300 226-Current Good Manufacturing Practice a significant hazard to health, the state- 1.110 ----- 290.10 3.91 -------- 250.250 for Medicated Premixes ment: r ----- 200.15 250.109 1.115 3.94 -------- IMAPORTANT 201.300 229-Current Good Manufacturing Practice 3.3 --------- 3.95 -------- 250.110 DRUG 3.4 --------- 201.302 3.501 ----- 200.5 for Certain Other Drug Products WARNZING 3.7--------- 250.108 3.502 ----- 201.19 250-Special Requirements for Specific Hu- 3.8 --------- 250.101 3.503 ----- 201.312 man Drugs The statement shall be In three lines, all 3.11 -------- 201.301 3.505 ----- 201.313 capitals, and centered. "Important" shall Drugs 3.12 ------- 201.304 3.506 ----- 200.11 290-Controlled be in 36 point Gothic Bold type. "Drug" 3.15 -------- 201.306 3.507 _- ---201.17 29-Drugs; Official Names and Established and "Warning" shall be in 38 point 3.16 -------- 200.100 3.508 ----- 201.18 Names Gotl e Condensed type. The rectangle's FEDERAL REGISTER, VOL. 40, NO. 60-THURSDAY, MARCH 27, 1975 HeinOnline -- 40 Fed. Reg. 13996 1975 RULES AND REGULATIONS 13997 border-and -the statement therein shall Claimed Exemption for Investigational (b) The Commissloner concludes that be red. New Drug (IND), any information ob- such dangerous or potentially dangerous (2) When the information concerns tained during the inspection of an extra- practices include, but are not limited to, important changes In drug package mural facility having a specific bearing the following: labeling, the statement: on the compliance of the manufacturer's, (1) 'Some vegetable growers and IMPORTA.NT applicant's, or sponsor's product with packers employ used poultry crates for PRESCRIBING the Federal Food, Drug, and Cosmetic shipment of fresh vegetables, including INFORMATION Act. The Food and Drug Administration's cabbage and celery. Salmonella orga- The statement shall be in three lines, all position is that by the acceptance of such nisms are commonly present on dressed capitals, contract work, the extramural facility poultry and in excreta and fluid exu- and centered. "Important" shall authorizes such disclosures. dates from dressed birds. Thus wooden be in 36 point Gothic Bold type.