Knowledge (XXG)

Prescription Drug Marketing Act

Source ๐Ÿ“

38: 238: 421: 48:
An Act to amend the Federal Food, Drug, and Cosmetic Act to ban the reimportation of drugs produced in the United States, to place restrictions on the distribution of drug samples, to ban certain resales of drugs by hospitals and other health care facilities, and for other
497: 620: 490: 610: 483: 436: 268: 469: 283: 600: 313: 585: 615: 464: 263: 441: 323: 115: 135: 125: 538:. It was passed in response to the development of a wholesale sub-market (known as the "diversion market") for prescription drugs. 519: 393: 171: 605: 573: 328: 96: 88: 219: 557: 545: 459: 318: 58: 383: 376: 541:
The PDMA was modified by the Prescription Drug Amendments of 1992 (P.L. 102-353, 106 Stat. 941) on August 26, 1992.
431: 426: 295: 273: 37: 366: 548:(FDA) issued regulations implementing the PDMA in 1990 (21 C.F.R. Part 205) and 1999 (21 C.F.R. Part 203). 288: 249: 17: 361: 81: 568: 163: 563: 523: 388: 245: 398: 356: 148: 237: 527: 371: 346: 139: 594: 403: 203: 167: 531: 351: 175: 100: 535: 534:, adulterated, misbranded, sub potent, and expired prescription 621:
United States statutes that abrogate Supreme Court decisions
611:
United States federal controlled substances legislation
518:) of 1987 (P.L. 100-293, 102 Stat. 95) is a law of the 231:
Regulation of therapeutic goods in the United States
213: 146: 131: 121: 111: 106: 87: 77: 72: 64: 53: 44: 491: 8: 601:Pharmaceutical industry in the United States 30: 530:and is designed to discourage the sale of 526:distribution to ensure safe and effective 498: 484: 236: 227: 196:on March 31, 1988 (passed voice vote) 184:by House Committee on Energy and Commerce 616:United States federal health legislation 522:. It establishes legal safeguards for 314:Department of Health and Human Services 230: 190:on May 4, 1987 (passed voice vote) 31:Prescription Drug Marketing Act of 1987 29: 18:Prescription Drug Marketing Act (PDMA) 7: 264:Federal Food, Drug, and Cosmetic Act 220:Prescription Drug Amendments of 1992 442:Single Convention on Narcotic Drugs 116:Federal Food, Drug and Cosmetic Act 25: 520:United States federal government 394:Abbreviated New Drug Application 36: 27:Legislation in the United States 574:Regulation of therapeutic goods 512:Prescription Drug Marketing Act 279:Prescription Drug Marketing Act 454:Non-governmental organizations 1: 558:Food and Drug Administration 546:Food and Drug Administration 460:National Academy of Medicine 319:Food and Drug Administration 59:100th United States Congress 384:Randomized controlled trial 222:P.L. 102-353, 106 Stat. 941 637: 416:International coordination 427:Uppsala Monitoring Centre 296:Marihuana Tax Act of 1937 274:Controlled Substances Act 218: 155: 126:21 U.S.C.: Food and Drugs 35: 367:Investigational New Drug 182:Committee consideration 132:U.S.C. sections amended 606:Pharmaceuticals policy 250:Over-the-counter drugs 178:) on February 24, 1987 324:Department of Justice 362:New Drug Application 569:Inverse benefit law 399:Fast track approval 308:Government agencies 149:Legislative history 32: 246:Prescription drugs 564:Drug distribution 524:prescription drug 508: 507: 389:Pharmacovigilance 226: 225: 206:on April 22, 1988 194:Passed the Senate 90:Statutes at Large 16:(Redirected from 628: 500: 493: 486: 357:Drug development 284:Hatch-Waxman Act 240: 228: 214:Major amendments 188:Passed the House 162:in the House as 151: 142:ยงยง 331, 353, 381 91: 40: 33: 21: 636: 635: 631: 630: 629: 627: 626: 625: 591: 590: 582: 554: 528:pharmaceuticals 504: 475: 474: 455: 447: 446: 417: 409: 408: 342: 334: 333: 309: 301: 300: 259: 248: 209: 200:Signed into law 147: 89: 54:Enacted by 28: 23: 22: 15: 12: 11: 5: 634: 632: 624: 623: 618: 613: 608: 603: 593: 592: 589: 588: 581: 580:External links 578: 577: 576: 571: 566: 561: 553: 550: 506: 505: 503: 502: 495: 488: 480: 477: 476: 473: 472: 467: 462: 456: 453: 452: 449: 448: 445: 444: 439: 434: 429: 424: 418: 415: 414: 411: 410: 407: 406: 401: 396: 391: 386: 381: 380: 379: 372:Clinical trial 369: 364: 359: 354: 349: 347:Drug discovery 343: 340: 339: 336: 335: 332: 331: 326: 321: 316: 310: 307: 306: 303: 302: 299: 298: 293: 292: 291: 281: 276: 271: 266: 260: 257: 256: 253: 252: 242: 241: 233: 232: 224: 223: 216: 215: 211: 210: 208: 207: 197: 191: 185: 179: 164:H.R. 1207 156: 153: 152: 144: 143: 133: 129: 128: 123: 122:Titles amended 119: 118: 113: 109: 108: 104: 103: 93: 85: 84: 79: 75: 74: 70: 69: 68:April 22, 1988 66: 62: 61: 55: 51: 50: 46: 42: 41: 26: 24: 14: 13: 10: 9: 6: 4: 3: 2: 633: 622: 619: 617: 614: 612: 609: 607: 604: 602: 599: 598: 596: 587: 584: 583: 579: 575: 572: 570: 567: 565: 562: 559: 556: 555: 551: 549: 547: 542: 539: 537: 533: 529: 525: 521: 517: 513: 501: 496: 494: 489: 487: 482: 481: 479: 478: 471: 468: 466: 463: 461: 458: 457: 451: 450: 443: 440: 438: 435: 433: 430: 428: 425: 423: 420: 419: 413: 412: 405: 404:Off-label use 402: 400: 397: 395: 392: 390: 387: 385: 382: 378: 375: 374: 373: 370: 368: 365: 363: 360: 358: 355: 353: 350: 348: 345: 344: 338: 337: 330: 327: 325: 322: 320: 317: 315: 312: 311: 305: 304: 297: 294: 290: 287: 286: 285: 282: 280: 277: 275: 272: 270: 267: 265: 262: 261: 255: 254: 251: 247: 244: 243: 239: 235: 234: 229: 221: 217: 212: 205: 204:Ronald Reagan 202:by President 201: 198: 195: 192: 189: 186: 183: 180: 177: 173: 169: 165: 161: 158: 157: 154: 150: 145: 141: 137: 134: 130: 127: 124: 120: 117: 114: 110: 105: 102: 98: 94: 92: 86: 83: 80: 76: 71: 67: 63: 60: 56: 52: 47: 43: 39: 34: 19: 586:PDMA article 543: 540: 515: 511: 509: 278: 199: 193: 187: 181: 168:John Dingell 159: 112:Acts amended 107:Codification 532:counterfeit 352:Drug design 595:Categories 560:(FDA, USA) 289:exemptions 160:Introduced 78:Public law 45:Long title 544:The U.S. 136:21 U.S.C. 95:102  73:Citations 65:Effective 49:purposes. 552:See also 341:Process 82:100-293 377:phases 269:CDAPCA 99:  536:drugs 470:NORML 465:RADAR 437:CIOMS 140:ch. 9 138: 97:Stat. 516:PDMA 510:The 57:the 432:WHO 422:ICH 329:DEA 258:Law 166:by 597:: 176:MI 101:95 514:( 499:e 492:t 485:v 174:โ€“ 172:D 170:( 20:)

Index

Prescription Drug Marketing Act (PDMA)
Great Seal of the United States
100th United States Congress
100-293
Statutes at Large
Stat.
95
Federal Food, Drug and Cosmetic Act
21 U.S.C.: Food and Drugs
21 U.S.C.
ch. 9
Legislative history
H.R. 1207
John Dingell
D
MI
Ronald Reagan
Prescription Drug Amendments of 1992

Prescription drugs
Over-the-counter drugs
Federal Food, Drug, and Cosmetic Act
CDAPCA
Controlled Substances Act
Prescription Drug Marketing Act
Hatch-Waxman Act
exemptions
Marihuana Tax Act of 1937
Department of Health and Human Services
Food and Drug Administration

Text is available under the Creative Commons Attribution-ShareAlike License. Additional terms may apply.

โ†‘