Guidance for Industry 

Contents of a Complete 

Submission for the Evaluation 

of Proprietary Names 

DRAFT GUIDANCE
 

This guidance document is being distributed for comment purposes only. 

Comments and suggestions regarding this draft document should be submitted within 60 days of 

publication in the Federal Register of the notice announcing the availability of the draft 

guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and 

Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments 

should be identified with the docket number listed in the notice of availability that publishes in 

the Federal Register. 

For questions regarding this draft document contact Carol Holquist 301-796-2360 (CDER), or 

(CBER) Ele Ibarra-Pratt at 301-827-3028 (CBER). 

U.S. Department of Health and Human Services 

Food and Drug Administration 

Center for Drug Evaluation and Research (CDER) 

Center for Biologics Evaluation and Research (CBER) 

November 2008 

Labeling 
 

 

 

Guidance for Industry 

Contents of a Complete 

Submission for the Evaluation 

of Proprietary Names 

Additional copies are available from: 

Office of Communications
 

Division of Drug Information
 

Center for Drug Evaluation and Research
 

Food and Drug Administration 

10903 New Hampshire Ave. 

Bldg. 51, Room 2201
 

Silver Spring, MD 20993-0002
 

(Tel) 301-796-3400

 http://www.fda.gov/cder/guidance/index.htm 

and/or

 Office of Communication, Training and
 

Manufacturers Assistance, HFM-40 

Center for Biologics Evaluation and Research 

Food and Drug Administration 

1401 Rockville Pike, Rockville, MD 20852-1448 

 http://www.fda.gov/cber/guidelines.htm. 

(Tel) 800-835-4709 or 301-827-1800
 

U.S. Department of Health and Human Services 

Food and Drug Administration 

Center for Drug Evaluation and Research (CDER) 

Center for Drug Evaluation and Research (CBER) 

November 2008 

Labeling 
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TABLE OF CONTENTS 

I.	 INTRODUCTION............................................................................................................. 1
 

II.	 BACKGROUND ............................................................................................................... 2
 

A. Recommendations to Minimize Medication Errors....................................................................2
 

B. Medication-Use Systems................................................................................................................3
 

C. Proprietary Name Confusion and Medication Errors................................................................4
 

D. FDA’s Approach to the Evaluation of Proposed Proprietary Names.......................................4
 

E. Regulatory Authority.....................................................................................................................6
 

III. CONTENTS OF A COMPLETE SUBMISSION FOR EVALUATION OF 

PROPOSED PROPRIETARY NAMES..................................................................................... 7
 

A. General Information......................................................................................................................8
 

B. Proposed Proprietary Name .........................................................................................................8
 

1. Primary and Alternate Proprietary Name .......................................................................................8
 

2. Intended Pronunciation of the Proposed Proprietary Name ...........................................................8
 

3. Derivation of Proprietary Name.....................................................................................................9
 

4. Intended Meaning of Proprietary Name Modifiers (e.g., prefix, suffix) ..........................................9
 

5. Pharmacologic/Therapeutic Category.............................................................................................9
 

C. Additional Information about the Product..................................................................................9
 

1. Submission for a Product That Has Proposed Labels and Labeling...............................................9
 

2. Submission for a Product Without Proposed Labeling..................................................................10
 

D. Information about Product Dispensing and Delivery..............................................................12
 

1. Likely Care Environment(s) for Dispensing and Use ....................................................................12
 

2. Delivery System..............................................................................................................................13
 

3. Measuring Device ..........................................................................................................................13
 

E. Assessments of Proprietary Name, Packaging, and/or Labeling.............................................13
 

IV.	 WHEN AND WHERE TO SEND A SUBMISSION FOR A PROPOSED 

PROPRIETARY NAME REVIEW .............................................................................. 13
 

A. Drug Products, Including Biologics, That Are the Subject of an IND, NDA, or BLA — 

Paper Submission.........................................................................................................................14
 

1. Submissions for Proposed Proprietary Names for Prescription Drugs, Including Biologics, 

That Are the Subject of an IND, NDA, or BLA Reviewed by CDER..............................................14
 

2. Submissions for Proposed Proprietary Names for Prescription Drugs, Including Biologics, 

That Are the Subject of an IND, NDA, or BLA Reviewed by CBER ..............................................14
 

3. Submissions for Proposed Proprietary Names for Nonprescription Drugs That Are the 

Subject of an NDA..........................................................................................................................14
 

B. Drugs Products That Are the Subject of an ANDA — Paper Submission .............................14
 

C. Electronic Submissions................................................................................................................14
 

GLOSSARY................................................................................................................................. 16
 

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40 

41 

42 Guidance for Industry1 

43 Contents of a Complete Submission for the Evaluation of 

44 Proprietary Names 

45 

46 

47 

48 This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current 

49 thinking on this topic. It does not create or confer any rights for or on any person and does not operate to 

50 bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of 

51 the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA 

52 staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call 

53 the appropriate number listed on the title page of this guidance. 

54 

55 

56 

57 I. INTRODUCTION 

58 

59 Accurate identification of medications is critical to preventing medication errors2 and potential 

60 harm to the public. This guidance is intended to assist industry in the submission of a complete 

61 package of information that FDA will use in the assessment both of the safety aspects of a 

62 proposed proprietary name, to reduce medication errors, and of the promotional implications of 

63 a proposed name, to ensure compliance with other requirements for labeling and promotion 

64 This guidance applies to proprietary name submissions for the following types of products: 

65 

66 • Prescription drug products, including biologics, that are the subject of a new drug 

67 application (NDA), an abbreviated new drug application (ANDA), or a biologics license 

68 application (BLA), or that are currently the subject of an investigational new drug 

69 application (IND) in anticipation of submission in a marketing application. 

70 • Nonprescription drug products that are the subject of an NDA or ANDA 

71 

72 FDA’s guidance documents, including this guidance, do not establish legally enforceable 

73 responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should 

74 be viewed only as recommendations, unless specific regulatory or statutory requirements are 

75 cited. The use of the word should in Agency guidances means that something is suggested or 

76 recommended, but not required. 

77 

1

 This guidance has been prepared by the Division of Medication Error Prevention and Analysis, Office of 

Surveillance and Epidemiology, in the Center for Drug Evaluation and Research (CDER) in cooperation with the 

Advertising and Product Labeling Branch in the Center for Biologics Evaluation and Research (CBER) at the Food 

and Drug Administration. 

2

 All terms presented in bold italics at first use in this guidance are defined in the Glossary. 

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78 II. BACKGROUND 

79 

80 On September 27, 2007, the reauthorization and expansion of the Prescription Drug User Fee Act 

81 (PDUFA IV) was signed into law as part of Public Law 110-85, 121 Stat. 823. The 

82 reauthorization of PDUFA significantly broadens and strengthens the Food and Drug 

83 Administration’s (FDA) drug safety program, facilitating more efficient development of safe and 

84 effective new medications for the American public. As part of the reauthorization of PDUFA 

85 IV, FDA committed to certain performance goals in its goals letter.3 In that letter, FDA stated 

86 that it would use user fees to implement various measures to reduce medication errors related to 

87 look-alike and sound-alike proprietary names, unclear label abbreviations, acronyms, dose 

88 designations, and error-prone label and packaging designs. 

89 

90 Among these measures, FDA agreed to publish guidance on the contents of a complete 

91 submission package for a proposed proprietary name for a drug or biological product. FDA also 

92 agreed to performance goals for review of proprietary names submitted during the IND phase or 

93 with an NDA or BLA; the goals stipulate that a complete submission is required to begin the 

94 review clock. 

95 

96 

97 A. Recommendations to Minimize Medication Errors 

98 

99 This guidance and other PDUFA IV proprietary name evaluation measures grow out of 

100 initiatives aimed at minimizing medication errors. 

101 

102 In 2000, the Institute of Medicine (IOM) published a report entitled To Err Is Human: Building 

103 a Safer Health System.

4 The report stated that from 44,000 to 98,000 deaths occur yearly due to 

104 medical errors, making medical errors the eighth leading cause of death in the United States. 5 

105 The report identified medication errors as the most common type of error in health care. Seven 

106 thousand (7,000) deaths annually were attributed to medication errors.6 The IOM recommended 

107 that FDA 

3

 See goals letter from the Secretary of Health and Human Services to the Chairman of the Committee on Health, 

Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the 

House of Representatives, as set forth in the Congressional Record, at 

http://www.fda.gov/oc/pdufa4/pdufa4goals.html. (goals letter). 

4

 Kohn LT, Corrigan JM, Donaldson MS, eds. To Err Is Human: Building a Safer Health System. Institute of 

Medicine, National Academies Press: Washington DC. 2000. 

5

 American Hospital Association. Hospital Statistics. Chicago. 1999. See also: Brennan TA, Leape LL, Laird NM., 

et al. Incidence of Adverse Events and Negligence in Hospitalized Patients: Results of the Harvard Medical Practice 

Study I. N Engl J Med. 324:370-376, 1991; Leape LL, Brennan TA, Laird NM, et al. The Nature of Adverse Events 

in Hospitalized Patients: Results of the Harvard Medical Practice Study II. N Engl J Med. 324(6):377-384, 1991; 

Centers for Disease Control and Prevention (National Center for Health Statistics). Births and Deaths: Preliminary 

Data for 1998. National Vital Statistics Reports. 47(25):6, 1999, cited in To Err Is Human, p. 1. 

6 Phillips, DP, Christenfeld, N, and Glynn, LM. Increase in US Medication-Error Deaths between 1983 and 1993. 

The Lancet. 351:643-644, 1998, cited in To Err Is Human, p. 2. 

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108 ● “develop and enforce standards for the design of drug packaging and labeling that 

109 will maximize safety in use” and 

110 ● “require pharmaceutical companies to test proposed drug names to identify and 

111 remedy potential sound-alike and look-alike confusion with existing drug names.”7 

112 

113 In July 2006, the IOM published a report entitled Preventing Medication Errors. In this report, 

114 the IOM cited labeling and packaging issues as the cause of 33 percent of medication errors, 

115 including 30 percent of fatalities from medication errors.8 Given the critical role of the label and 

116 labeling in the safe use of drug products, this statistic is not surprising. The container label, 

117 carton, and (for prescription drug products) professional insert labeling are the primary means 

118 by which practitioners and patients identify and make decisions about using the product. Carton 

119 and container labels communicate critical information including proprietary and established 

120 name, strength, dosage form, container quantity, and expiration date, and are particularly critical 

121 for nonprescription (over-the-counter (OTC)) products. For prescription products, the 

122 professional insert labeling is intended to communicate to practitioners all information relevant 

123 to the approved uses of the product, including the correct dosing and administration. 

124 

125 The July 2006 IOM report stated that “Product naming, labeling, and packaging should be 

126 designed for the end user — the provider in the clinical environment and/or the consumer.”9 

127 The report also urged FDA to incorporate better principles of cognitive and human factors 

128 engineering to address issues concerning information presentation in labeling and 

129 nomenclature.10 

130 

131 In addition to the IOM recommendations, the Secretary of Health and Human Services published 

132 a report titled Bringing Common Sense to Health Care Regulation: Report of the Secretary’s 

133 Advisory Committee on Regulatory Reform (November 2002). This report recommended that 

134 FDA adopt safe labeling practices for all FDA-regulated products to improve patient safety and 

135 decrease preventable adverse drug events. 

136 

137 B. Medication-Use Systems 

138 

139 Medication use within a health care organization can be viewed as a system with several 

140 components and processes, including: 

141 ● inputs (patient and drug therapy information), 

142 ● throughputs (care provided), and 

7

 This effort is also consistent with FDA's May 10, 1999 report to the FDA Commissioner titled Managing the Risks 

From Medical Product Use, which underscored the importance of providing an adequate risk assessment associated 

with the use of drug products, including a mandate to reduce medication errors from proprietary name confusion. 

8

 Aspden P, Wolcott JA, Bootman JL, Cronenwett LR, eds. Preventing Medication Errors. Institute of Medicine, 

The National Academies Press: Washington DC. 2006. Chapter 6: p. 275. 

9

 IOM, Preventing Medication Errors. Chapter 6, Recommendation 4, p. 280. 

10 IOM, Preventing Medication Errors. Chapter 2, p. 61. 

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143 ● outputs (effective, efficient, and safe treatment).11 

144 

145 Depending on the setting and organization, there are many variables interacting within a 

146 medication-use system. These variables include, but are not limited to 

147 ● different processes and procedures, 

148 ● different types of health care providers involved, 

149 ● different patients, 

150 ● different products, 

151 ● different storage and dispensing conditions, and 

152 ● different available technologies. 

153 

154 The many variables and interactions within the medication-use system create ample opportunity 

155 for confusion and medication errors. 

156 

157 C. Proprietary Name Confusion and Medication Errors 

158 

159 In the U.S. medication-use system, health care providers rely on the proprietary name as the 

160 critical identifier of the appropriate therapy in a market of thousands of products; therefore, 

161 accurate interpretation of the product name is essential to ensure that the correct product is 

162 procured, prescribed, prepared, dispensed, and administered to the patient. Products “might be 

163 prone to error in use due to sound-alike or look-alike names, unclear labeling, or poorly designed 

164 packaging.”

12 Product names that look and/or sound alike can lead to medication error and 

165 potential harm to patients by increasing the risk that health care providers could misunderstand 

166 the product name, prescribe the wrong product, dispense and/or administer the wrong product, or 

167 dispense a product incorrectly. Similarly, product names that look and/or sound alike may lead 

168 consumers to select or administer their nonprescription medication incorrectly. 

169 

170 D. FDA’s Approach to the Evaluation of Proposed Proprietary Names 

171 

172 As part of its premarket review of products that are the subject of an NDA, BLA, or ANDA, 

173 FDA evaluates both safety and promotional aspects of the product’s proposed proprietary 

174 name.13 

175 

176 FDA’s safety review of a proposed proprietary name focuses on the prevention of medication 

177 errors. Accurate identification of medications is critical to preventing medication errors and 

178 potential harm to the public. Because medication error due to product misidentification or 

179 confusion can occur at any point in the medication-use system, in its evaluation of a proposed 

180 proprietary name, FDA considers the potential for confusion throughout the entire U.S. 

11 Medication Use: A Systems Approach to Reducing Errors. Joint Commission on Accreditation of Healthcare 

Organizations, 1998. p. 6. 

12 IOM, To Err Is Human, p. 136. 

13 Legal authorities are explained in the next section. 

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181 medication-use system, including product procurement, prescribing and ordering, dispensing, 

182 administration, and monitoring the effects of the medication.14 

183 

184 The overall medication error safety assessment is based on the findings of a Failure Modes and 

185 Effects Analysis (FMEA) of the proprietary name. FMEA is a systematic tool for evaluating a 

186 process and identifying where and how it might fail.15 FMEA is used to analyze whether a 

187 proposed proprietary name has look- or sound-alike similarities to the names of existing products 

188 that could cause confusion and subsequently lead to medication errors in the clinical setting. 

189 

190 To fully assess the safety of proprietary names, it is essential that certain product characteristics 

191 be considered in the overall risk assessment. The proprietary name and product characteristics 

192 provide the framework for how product variables will interact within the medication-use system 

193 and provide the context for the verbal and written communication of the drug name. Product 

194 characteristics can act together with the orthographic and phonologic attributes of the proprietary 

195 name (1) to increase the risk of confusion when there is an overlap in product characteristics 

196 among two or more products, or (2) in some instances, to decrease the risk of confusion by 

197 helping to differentiate products through dissimilarity. FDA considers product characteristics 

198 throughout the risk assessment because the product characteristics provide a context for 

199 communication of the proprietary name and ultimately determine the use of the product in the 

200 usual clinical practice setting. 

201 

202 FDA considers typical product characteristics that could lead to confusion with other products, 

203 including, but not limited to, the following: 

204 ● established name of the product 

205 ● proposed indication 

206 ● dosage form 

207 ● route of administration 

208 ● strength 

209 ● unit of measure 

210 ● dosage units 

211 ● recommended dose 

212 ● typical quantity or volume 

213 ● frequency of administration 

214 ● product packaging 

215 ● storage conditions 

216 ● patient population 

217 ● prescriber population 

218 

219 FDA staff use the product characteristics in the analysis of a proprietary name to anticipate the 

220 clinical setting(s) in which the product is likely to be used. 

221 

222 In addition to the safety review, FDA conducts a promotional review of proposed proprietary 

223 names. This promotional review considers whether the name functions to overstate the efficacy, 

14 IOM, Preventing Medication Errors. 

15 Institute for Healthcare Improvement (IHI). Failure Modes and Effects Analysis. Boston. IHI:2004. 

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224 minimize the risk, broaden the indication, or make unsubstantiated superiority claims for the 

225 product, or is overly “fanciful” by misleadingly implying unique effectiveness or composition, or 

226 is otherwise false or misleading. (See 21 U.S.C 321(n), 352(a) and (n); see also 21 CFR 201.10 

227 (c)(3), 202.1(e)(5)(i), and (e)(6)(i).) 

228 

229 E. Regulatory Authority 

230 

231 FDA’s authority to obtain submissions that address proprietary names and regulate proprietary 

232 names is based on the Federal Food, Drug, and Cosmetic Act (the Act) and Agency regulations. 

233 Among these authorities are the following: 

234 

235 Proprietary names are used in a product’s labels and labeling, as well as in other promotional 

236 materials. Under section 502(a) of the Act (21 U.S.C. 352(a)), a drug, including a biologic, is 

237 misbranded if its labeling is false or misleading in any particular. In addition, section 351(b) of 

238 the Public Health Service Act (42 U.S.C. 262(b)) prohibits falsely labeling or marking any 

239 package or container of any biological product.16 Under section 505(d)(7) of the Act (21 U.S.C. 

240 355(d)(7)), an NDA or ANDA shall not be approved if the drug's labeling is false or misleading 

241 in any particular. (See also 21 CFR 314.125 (b)(6) and (b)(8) (grounds for disapproval of NDA 

242 or ANDA including that proposed labeling is false or misleading in any particular or that 

243 labeling does not comply with requirements of 21 CFR part 201); 21 CFR 314.105(c)(requiring 

244 compliance with statutory standards for labeling in order to approve an NDA or ANDA); 21 

245 CFR 601.4(b)(BLA shall be denied if establishment or product does not meet requirements 

246 specified in FDA regulations, including requirements of part 201).) NDAs, ANDAs, and BLAs 

247 must contain labeling and all other information about the drug that is pertinent to evaluation of 

248 the application, to provide FDA with a basis on which to make the required findings for approval 

249 or licensure. (See 21 CFR 314.50; 21 CFR 601.2.) 

250 

251 Section 201(n) (21 U.S.C. 321(n)) indicates that when a drug is alleged to be misbranded 

252 because its labeling or advertising is misleading, the determination of whether the labeling or 

253 advertising is misleading should take into account (among other things): 

254 

255 not only representations made or suggested by statement, word, design, device, or any 

256 combination thereof, but also the extent to which the labeling or advertising fails to 

257 reveal facts material in the light of such representations or material with respect to 

258 consequences which may result from the use of the article to which the labeling or 

259 advertising relates under the conditions of use prescribed in the labeling or advertising 

260 thereof or under such conditions of use as are customary or usual. 

261 

16 See also section 502(n) of the Act, 21 U.S.C. 352(n) (advertising of a prescription drug 

misbrands unless it contains a true statement of other information in brief summary relating to 

side effects, contraindications, and effectiveness); 21 CFR 202.1(e)(5)(addressing "true 

statement" requirement).; 21 CFR 202.1(k) (prescription drugs misbranded if not compliant with 

section 502(n) of the act and implementing regulations). 

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262 In addition to this general principle, applicable to proprietary names, several FDA regulations 

263 specifically address ways in which the name of a drug may render its labeling misleading. For 

264 example, FDA regulations at 21 CFR 201.6(b) state: 

265 

266 The labeling of a drug which contains two or more ingredients may be misleading by 

267 reason, among other reasons, of the designation of such drug in such labeling by a name 

268 which includes or suggests the name or one or more but not all such ingredients, even 

269 though the names of such ingredients are stated elsewhere in the labeling. 

270 

271 Likewise, 21 CFR 201.10(c) states that the labeling of a drug may be misleading by reason of: 

272 

273 (3) The employment of a fanciful proprietary name for a drug or ingredient in such a 

274 manner as to imply that the drug or ingredient has some unique effectiveness or 

275 composition when, in fact, the drug or ingredient is a common substance, the limitations 

276 of which are readily recognized when the drug or ingredient is listed by its established 

277 name. 

278 . . . . 

279 

280 (5) Designation of a drug or ingredient by a proprietary name that, because of similarity 

281 in spelling or pronunciation, may be confused with the proprietary name or the 

282 established name of a different drug or ingredient. 

283 

284 Based on these authorities, applicants must submit, and FDA reviews, proprietary names as part 

285 of NDAs, ANDAs, and BLAs. To further their business goals, many drug manufacturers prefer 

286 to have FDA evaluate a proposed proprietary name even earlier in the drug development process, 

287 when possible. Consequently, FDA permits manufacturers, if they wish, to seek FDA’s initial 

288 evaluation of a proposed proprietary name prior to the submission of the marketing application, 

289 while the product remains under an IND. However, to ensure that resources are not used to 

290 evaluate proposed proprietary names for products that will not be viable candidates for an NDA, 

291 ANDA, or BLA, or for which proposed indications are not yet sufficiently clear to form the basis 

292 of an evaluation of a name for potential medication errors, FDA does not evaluate proprietary 

293 names until products have completed phase 2 trials. 

294 

295 

296 III. CONTENTS OF A COMPLETE SUBMISSION FOR EVALUATION OF 

297 PROPOSED PROPRIETARY NAMES 

298 

299 This section describes the information FDA recommends that a sponsor or applicant include in 

300 order to ensure that the Agency can conduct a complete review of a proposed proprietary name. 

301 As described in section II.D, FDA evaluates orthographic and phonological characteristics of the 

302 proposed name in connection with product characteristics, to evaluate the acceptability of the 

303 proposed proprietary name. This section provides recommendations applicable to submissions 

304 for products with proposed labels and labeling, and for products for which proposed labels and 

305 labeling have not yet been developed. In accordance with the PDUFA goals, the review clock 

306 for a proprietary name evaluation will not begin if a submission is not complete. FDA will notify 

307 the applicant or sponsor in writing if it considers a submission to be incomplete. 

308 

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309 A. General Information 

310 

311 Each submission should be identified as follows: 

312 

313 • For proprietary name reviews, include the statement “REQUEST FOR PROPRIETARY 

314 NAME REVIEW” in bold, capital letters on the first page of the submission. 

315 

316 • For proprietary names that applicants and sponsors are submitting for reconsideration 

317 following an initial rejection of their proposed names, include the statement “REQUEST 

318 FOR RECONSIDERATION OF PROPRIETARY NAME” in bold, capital letters on the 

319 first page of the submission. 

320 

321 A proprietary name evaluation submission for a drug product, including a biologic, that is the 

322 subject of an IND should include FDA Form 1571; a proprietary name evaluation submission for 

323 a drug product, including a biologic, that is the subject of an NDA, ANDA, or BLA should 

324 include FDA Form 356h. The forms should provide information including the following: 

325 

326 ● Proposed first choice proprietary name 

327 ● Application number (BLA/NDA/ANDA/IND) 

328 ● Applicant or sponsor contact information including the company name, name and title of 

329 the contact person, address, phone number, fax number, and e-mail address 

330 ● Identification of the submission as a Request for Proprietary Name Review, Request for 

331 Reconsideration of Proprietary Name, or Amendment to a Request for Proprietary Name 

332 Review.17 

333 ● A list of contents in the submission 

334 

335 B. Proposed Proprietary Name 

336 

337 All submissions should include the following information about the proposed proprietary name. 

338 

339 1. Primary and Alternate Proprietary Name 

340 

341 The applicant or sponsor should propose up to two proprietary names for review in a submission 

342 and should specify the first choice. The alternate name will be evaluated only in the event the 

343 primary name is found to be unacceptable. 

344 

345 2. Intended Pronunciation of the Proposed Proprietary Name 

346 

347 Although FDA evaluates the various pronunciations of a proposed name to reflect the variations 

348 that might be observed in clinical practice, consideration is given to the pronunciation of the 

17 On FDA Form 1571, we recommend that you include this information under Box 11, by checking "Other" and 

providing the applicable description in the accompanying box. On FDA Form 356h, we recommend you include this 

information in response to the question on “Type of Submission,” by checking “Other” and providing the applicable 

description in the accompanying box. 

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349 name that the applicant or sponsor will promote, as this may influence pronunciation of the name 

350 in practice. 

351 

352 3. Derivation of Proprietary Name 

353 

354 The submission should include an explanation of the derivation of the proposed proprietary 

355 name, if any. 

356 

357 4. Intended Meaning of Proprietary Name Modifiers (e.g., prefix, suffix) 

358 

359 A modifier, such as a prefix or suffix, in the proprietary product name might suggest different 

360 meanings to health care professionals and consumers, which could potentially lead to product 

361 confusion. When an applicant or sponsor submits a product name with a modifier (for example, 

362 with the prefix Lo- or the suffix XR), the submission should include the intended meaning of the 

363 modifier, the rationale for the modifier, and any studies that have been conducted to support the 

364 use of the modifier. 

365 

366 5. Pharmacologic/Therapeutic Category 

367 

368 The submission should include the pharmacologic/therapeutic category under which the product 

369 with the proposed proprietary name will be classified. 

370 

371 C. Additional Information about the Product 

372 

373 This section describes what should be included in a submission when a product has a proposed 

374 label and labeling, and what should be included in a submission when a product does not yet 

375 have a proposed label and labeling. 

376 

377 1. Submission for a Product That Has Proposed Labels and Labeling 

378 

379 a. Proposed Labeling 

380 

381 The submission should include a copy of the proposed labeling in color and reflecting the 

382 presentation that will be used in the marketplace. In the case of a prescription product, the 

383 professional labeling, also referred to as physician labeling or the package insert, provides 

384 important information for FDA’s evaluation of proprietary names and other factors in association 

385 with the name that can contribute to product confusion. If a proposed patient package insert or 

386 proposed Medication Guide is available, it should also be included. See section III.C.2 of the 

387 guidance for a list of information that should be provided if the submission does not include the 

388 proposed labeling. 

389 

390 b. Container Labels and Labeling 

391 

392 The submission should include the proposed container label and other proposed external labeling 

393 or packaging, such as carton labels, pouches or overwraps, and sample labels. The submission 

394 should indicate the size of the actual label and provide the label, labeling, and packaging in color 

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395 and reflect the presentation that will be used in the marketplace, so that FDA can assess the 

396 presentation of the product name and information. For small labels and labeling, please provide 

397 the original copy and a larger copy for ease of review. 

398 

399 FDA will evaluate the proposed container labels and other proposed external labeling to identify 

400 potential problems with the proposed design or presentation of information that could contribute 

401 to confusion in a real world environment and lead to medication errors, where coupled with some 

402 similarity in proprietary names. For example: 

403 

404 ● If critical information, such as the drug name and concentration, is not displayed prominently 

405 or is masked by more prominent but less critical information, these factors could contribute 

406 to confusion and possible medication errors. 

407 

408 ● If product names are obscured by a logo or are illegible because of the font or color of the 

409 text, these factors could lead to name confusion or product selection errors. 

410 

411 ● The similar appearance of labels or labeling among different drugs or different dosage 

412 strengths of drugs could contribute to selection of an incorrect drug or product strength where 

413 product names are similar. 

414 

415 The possibility of this type of error is increased when products have similar names. 

416 

417 2. Submission for a Product Without Proposed Labeling 

418 

419 If the proposed labeling is not available at the time of the proprietary name submission, the 

420 following information should be provided for FDA’s evaluation. (This information is normally 

421 contained in professional labeling.) 

422 

423 a. Established Name 

424 

425 The submission should include the established name. An established name could contribute to 

426 product name confusion. For instance, if the established name itself is similar in appearance or 

427 pronunciation to the proprietary or established names of existing products, it may compound the 

428 potential for confusion if the proposed proprietary name of the product is also similar to other 

429 names. In addition, the established name can factor into the choice of product storage location. 

430 For example, certain institutions store medications by established name, not proprietary name. 

431 Having the established name thus helps FDA to determine what other product names will likely 

432 be displayed on the pharmacy shelf in close proximity to the proposed proprietary name. 

433 

434 b. Prescription Status 

435 

436 Prescription status affects storage location and clinical conditions of use. Therefore, the 

437 submission should include information about whether the product will be available without a 

438 prescription and/or by prescription. If the product is a controlled substance listed in schedule II, 

439 III, IV, or V of the Federal Controlled Substances Act or implementing regulations, the 

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440 submission should also include the assigned schedule (e.g., schedule II). The submission should 

441 note if product scheduling is pending. 

442 

443 c. Dosage Form(s) 

444 

445 The submission should include the finished dosage form, an important product characteristic for 

446 correct prescribing, dispensing, use, and storage of a product. 

447 

448 d. Product Strength(s) 

449 

450 The submission should include all proposed product strengths, because product strength is an 

451 important consideration when prescribing and dispensing a product. Product strength 

452 information is also important when determining potential confusion with other products and/or 

453 product line extensions. For instance, errors in selection of a wrong product can occur because 

454 of overlapping strengths between products that are available in multiple dosage formulations. 

455 Errors can also occur in selecting the correct product strength if the strengths are not presented 

456 clearly on the label or labeling. 

457 

458 e. Proposed Indication(s) for Use 

459 

460 The proposed submission should include the indications for use, which provide insight into the 

461 prescribing and patient populations and potential clinical care environments in which the product 

462 will be used and stored. 

463 

464 f. Route(s) of Administration 

465 

466 The submission should include the route of administration, which provides additional context to 

467 product prescribing, storage, dispensing, clinical care environment, and patient use. For instance, 

468 the route of administration can influence the environment in which the product is prescribed 

469 (e.g., inpatient setting vs. outpatient setting) and prepared for dispensing (e.g., sterile vs. 

470 nonsterile) and ultimately the finished dosage form (e.g., vial, IV admixture bag, tablet). 

471 Similarities and/or dissimilarities in the routes of administration can affect the potential for 

472 medication errors. 

473 

474 g. Usual Dosage, Frequency of Administration, Dosing Interval, Maximum 

475 Daily Dose 

476 

477 The submission should include information about the usual dosage, including the frequency of 

478 administration, the specific dosing interval, and the maximum daily dose. Similarities to or 

479 overlaps with other products in any of these areas can contribute to potential medication errors. 

480 

481 h. Dosing in Specific Populations 

482 

483 The submission should include a description of dosing modifications that are dependent on renal 

484 and/or hepatic function, age, or gender. This information provides insight into additional areas 

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485 of potential overlap or similarity with other product lines or products in dosing or frequency of 

486 administration. 

487 

488 i. Instructions for Use 

489 

490 The submission should include a detailed description of and step-by-step instructions for product 

491 use, if applicable, such as instructions for preparation and administration of IV products. The 

492 description should communicate whether the product will be self-administered by the patient or 

493 will require a skilled health professional to administer it. Instructions for use information can 

494 help identify similarities with other products that, in combination with proprietary name 

495 similarities, could lead to product confusion. 

496 

497 j. Storage Requirement 

498 

499 The submission should include the storage requirement for the product both pre- and post500 dispensing. Storing products with similar names in similar locations (for example, in a 

501 refrigerator) can contribute to medication errors in all levels of the medication-use system 

502 (warehouse, pharmacy, clinical care environment, or patient home). 

503 

504 k. How Supplied and Packaging Configuration 

505 

506 The submission should include information detailing how the product will be supplied and 

507 packaged. This information should include a description of the proposed product packaging, such 

508 as blister packs or inhalers. Product packaging is used by health care practitioners and 

509 consumers to select and administer the correct medication and dose and is the primary means by 

510 which practitioners and patients identify and use the product. The submission should also 

511 include the product strength, net quantity/size of all containers, and whether the product will be 

512 supplied in any physician samples or starter packs. This information also helps to determine the 

513 potential for confusion of the proposed product with other products. For instance, selection of 

514 the wrong product can occur where products with similar names also have similar net quantity, 

515 product strength, and/or packaging. 

516 

517 D. Information about Product Dispensing and Delivery 

518 

519 All submissions should contain the following information about product dispensing and delivery 

520 for FDA to complete a proprietary name review. 

521 

522 1. Likely Care Environment(s) for Dispensing and Use 

523 

524 The submission should include a list of all the likely care environments for dispensing and use of 

525 the product. For example, include information about whether the product is expected to be used 

526 in an inpatient/hospital setting, long-term care facility, clinic, doctor’s office, or home. Also 

527 describe the proposed distribution of the product, such as whether the product is to be dispensed 

528 from a retail or hospital pharmacy setting or distributed directly from the manufacturer or select 

529 wholesaler. This information provides insight into where an error might occur in the medication530 use system. 

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531 

532 2. Delivery System 

533 

534 If applicable, we recommend that the submission include a model and instructions for use of the 

535 product delivery system (e.g., transdermal patch) or product device (e.g., pen injector, inhaler). If 

536 no model is available, the submission should include a detailed description of the delivery system 

537 or device. Submitting this information allows FDA to assess the actual use of the product and 

538 identify possible similarities to a different product with a similar name. 

539 

540 3. Measuring Device 

541 

542 If the product is to be dispensed with a measuring device (such as a calibrated dosing cup), we 

543 recommend that the submission include the device. If no sample device is available, you should 

544 include a description of the device, including its measuring calibration and any text or graphics 

545 to be printed on the device. Submitting the measuring device allows FDA to assess whether 

546 products with similar names could be subject to product confusion and medication error based on 

547 similarities in dosing and administration or in overall appearance. 

548 

549 E. Assessments of Proprietary Name, Packaging, and/or Labeling 

550 

551 FDA encourages applicants to include any assessments of the proprietary name, packaging, 

552 and/or labeling that were conducted or commissioned by the applicant or sponsor. Such research 

553 is often helpful in identifying potential problems with the nomenclature and labeling of products 

554 and would aid the Agency’s review of the proprietary name, packaging, and labeling of a 

555 proposed product. However, FDA does not consider a submission incomplete because this 

556 information is not provided. 

557 

558 

559 IV. WHEN AND WHERE TO SEND A SUBMISSION FOR A PROPOSED 

560 PROPRIETARY NAME REVIEW 

561 

562 FDA generally encourages applicants and sponsors to submit their requests for FDA review of 

563 proposed proprietary names as soon as they have the recommended supporting information as 

564 described in this guidance. However, as explained in section II.E, if the request is submitted at 

565 the IND stage, it should be done no earlier than at the end of phase 2 of the IND process. 

566 Submissions may be in paper or electronic format. For paper submissions, the applicant or 

567 sponsor should submit three (3) copies of the submission to the same address as the original 

568 application with which the proprietary name is associated. For electronic submissions, see 

569 section IV.C below. 

570 

571 Applicants and sponsors should include on the first page of the submission the appropriate 

572 statement “REQUEST FOR PROPRIETARY NAME REVIEW” or “REQUEST FOR 

573 RECONSIDERATION OF PROPRIETARY NAME” in bold capital letters. 

574 

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575 A. Drug Products, Including Biologics, That Are the Subject of an IND, NDA, 

576 or BLA — Paper Submission 

577 

578 1. Submissions for Proposed Proprietary Names for Prescription Drugs, Including 

579 Biologics, That Are the Subject of an IND, NDA, or BLA Reviewed by CDER 

580 

581 Center for Drug Evaluation and Research 

582 Food and Drug Administration 

583 Document and Records Section 

584 5901-B Ammendale Rd 

585 Beltsville, MD 20705-1266 

586 

587 2. Submissions for Proposed Proprietary Names for Prescription Drugs, Including 

588 Biologics, That Are the Subject of an IND, NDA, or BLA Reviewed by CBER 

589 

590 FDA/CBER 

591 Document Control Center, HFM-99 

592 1401 Rockville Pike, Suite 200N 

593 Rockville, MD 20852-1448 

594 

595 3. Submissions for Proposed Proprietary Names for Nonprescription Drugs That 

596 Are the Subject of an NDA 

597 

598 DHHS/FDA/CDER/ONP 

599 5901-B Ammendale Road 

600 Beltsville, MD 20705-1266 

601 

602 B. Drugs Products That Are the Subject of an ANDA — Paper Submission 

603 

604 Center for Drug Evaluation and Research 

605 Food and Drug Administration 

606 Document and Records Section 

607 5901-B Ammendale Rd 

608 Beltsville, MD 20705-1266 

609 

610 C. Electronic Submissions 

611 

612 Applicants and sponsors who want to provide a proposed proprietary name submission 

613 electronically to CDER or CBER should refer to the FDA Web site “Electronic Common 

614 Technical Document (eCTD)” at http://www.fda.gov/cder/regulatory/ersr/ectd.htm and at 

615 http://www.fda/gov/cber/esub/esub.htm. Refer specifically to the following documents 

616 on that Web page: 

617 

618 • Guidance for industry on Providing Regulatory Submissions in Electronic Format — 

619 Human Pharmaceutical Product Applications and Related Submissions Using the 

620 eCTD Specifications 

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621 • eCTD Backbone File Specification for Module 1 

622 • FDA eCTD Table of Contents Headings and Hierarchy 

623 

624 Applicants and sponsors are encouraged to use the Electronic Submissions Gateway 

625 (ESG) to submit regulatory information. For information on the use of the ESG, refer to 

626 http://www.fda.gov/esg/. 

627 

628 

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629 

630 GLOSSARY 

631 

632 Because this guidance covers a wide range of products regulated by the Center for Drug 

633 Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research 

634 (CBER), we have defined, for purposes of this document, a number of terms used in the 

635 guidance to enhance comprehension and avoid potential confusion. 

636 

637 Applicant or sponsor: The entity that submits a proposed proprietary name submission for the 

638 following types of products: 

639 • Prescription drugs products (including biologics) that are the subject of an NDA (21 CFR 

640 314.3(b)), a BLA (21 CFR 601.2), or an ANDA (21 CFR 314.92), or that are currently 

641 the subject of an IND (21 CFR 312.3(b)) in anticipation of submission in a marketing 

642 application 

643 • Nonprescription drug products that are the subject of an NDA (21 CFR 314.3(b)) or 

644 ANDA (21 CFR 314.92) 

645 

646 Established name: The official name of the drug as defined under section 502(e)(3) of the Act 

647 (21 U.S.C. 352(e)(3)) and further described under 21 CFR 299.4, Established names for drugs; 

648 also known as “proper name” for biologics (see section 351(a)(1)(B)(ii) of the Public Health 

649 Service Act, 42 U.S.C. 262(a)(1)(B)(ii)). The established name is usually the name that has been 

650 derived by the U.S. Adopted Names Council (USAN). It is often the generic or common name of 

651 a product and can usually be found in the United States Pharmacopeia. 

652 

653 Label: As defined in section 201(k) of the Act, the term label means 

654 a display of written, printed, or graphic matter upon the immediate container of any 

655 article; and a requirement made by or under authority of this Act that any word, 

656 statement, or other information appear on the label shall not be considered to be complied 

657 with unless such word, statement, or other information also appears on the outside 

658 container or wrapper, if any there be, of the retail package of such article, or is easily 

659 legible through the outside container or wrapper. 

660 

661 Labeling: As defined in section 201(m) of the Act, the term labeling means “all labels and 

662 other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, 

663 or (2) accompanying such article.” Labeling includes outside containers, or wrappers, and 

664 package liners. 

665 

666 Medical error: The Institute of Medicine defines medical error as “the failure of a planned 

667 action to be completed as intended or the use of a wrong plan to achieve an aim.”18 Types of 

668 errors include diagnostic, treatment, preventive, and other (such as failure of communication, 

669 equipment, or system).19 

670 

18 IOM, To Err is Human. Chapter 1, p. 1. 

19 Leape, L, Lawthers, AG, Brennan, TA, et al. Preventing Medical Injury. Qual Rev Bull. 19(5):144-149, 1993, 

cited in To Err is Human, p. 1. 

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671 Medication error: The National Coordinating Council for Medication Error Reporting and 

672 Prevention describes medication error as 

673 any preventable event that may cause or lead to inappropriate medication use or 

674 patient harm while the medication is in the control of the health care professional, 

675 patient, or consumer. Such events may be related to professional practice, health 

676 care products, procedures, and systems, including prescribing; order 

677 communication; product labeling, packaging, and nomenclature; compounding; 

678 dispensing; distribution; administration; education; monitoring; and use.20 

679 

680 Medication-use system: The Institute of Medicine describes medication-use system as the 

681 system that 

682 encompasses the continuum of (1) prescribing by the clinician (or self683 prescribing), followed by transcribing; (2) preparing and dispensing by the 

684 pharmacist; (3) administering by the provider or consumer (self-care); and (4) 

685 monitoring for therapeutic and adverse effects (by nurse, surrogate, or self). 

686 Each of these steps includes critical control points at which decisions and actions 

687 can contribute to safety or errors.21 

688 

689 Product characteristics: The physical characteristics of the product itself (i.e., dosage form, 

690 strength, active ingredient) and environment in which the product is used, including but not 

691 limited to the established name, label, labeling, container, facility, storage conditions, who 

692 prescribes and administers the product, patient population, and other conditions of use. 

693 

694 Proprietary name: The trademark, trade name, or brand name. 

695 

696 

697 

20 National Coordinating Council for Medication Error Reporting and Prevention Web site, 

http://www.nccmerp.org/aboutMedErrors.html. 

21 IOM, Preventing Medication Errors, Chapter 2, p. 67. 

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