Drug Nomenclature

Drug nomenclature is the systematic naming of drugs, especially pharmaceutical drugs. Drugs, in the majority of circumstances, have 3 types of names: chemical names, the most important of which is the IUPAC name; generic or nonproprietary names, the most important of which are the International Nonproprietary Names (INNs); and trade names, which are brand names. Generic names for drugs are nowadays constructed out of affixes and stems that classify the drugs into different categories and also separate drugs within categories. A marketed drug might also have a company code or compound code.

Chemical names

The chemical names are the scientific names, based on the molecular structure of the drug. There are various systems of chemical nomenclature and thus various chemical names for any one substance. The most important is the IUPAC name. Chemical names are typically very long and too complex to be commonly used in referring to a drug.[1] Sometimes, a company that is developing a drug might give the drug a company code,[3] which is used to identify the drug while it is in development. For example, CDP870 is UCB’s company code for Cimzia.[1] Many of these codes, although not all, have prefixes that correspond to the company name. Example: 1-(Isopropylamino)-3-(1-naphthyloxy) propan-2-ol (propranolol).

Nonproprietary (generic) names

During development, the company will apply for regulatory approval of the drug by the relevant national regulatory agency (such as the U.S. Food and Drug Administration [FDA]), and it will apply for a generic (nonproprietary) name for that country (such as the United States Adopted Name [USAN] or Japanese Accepted Name [JAN]). It will also apply for an International Nonproprietary Name (INN) through the World Health Organization (WHO). Nowadays the national nonproprietary names are usually the same as the INN. The generic names usually indicate via their stems what drug class the drug belongs to.[4] For example, one can tell that aciclovir is an antiviral drug because its name ends in the -vir suffix.

Combination drug products

For combination drug products—those with 2 or more drugs combined into 1 dosage form—single nonproprietary names beginning with “co-” exist in both British Approved Name (BAN) form and in a formerly maintained USP name called the pharmacy equivalent name (PEN). Otherwise the 2 names are simply both given, joined by hyphens or slashes. For example, suspensions combining trimethoprim and sulfamethoxazole are called either trimethoprim/sulfamethoxazole or co-trimoxazole. Similarly, co-codamol is codeineacetaminophen, and co-triamterzide is triamterenehydrochlorothiazide. The USP ceased maintaining PENs, but the similar “co”-prefixed BANs are still current.

Trade (brand) names

For drugs that make it all the way through development, testing, and regulatory acceptance, the pharmaceutical company then gives the drug a trade name. The term trade name is a standard term in the pharmaceutical industry for a brand name or trademark name. For example, Lipitor is Pfizer‘s trade name for atorvastatin, a cholesterol-lowering medication.

 

An international nonproprietary name (INN) is an official generic and nonproprietary name given to a pharmaceutical drug or active ingredient.[2] International nonproprietary names make communication more precise by providing a unique standard name for each active ingredient, to avoid prescribing errors.[1] The INN system has been coordinated by the World Health Organization (WHO) since 1953.

Having unambiguous standard names for each drug (standardization of drug nomenclature) is important because a drug may be sold by many different brand names, or a branded medication may contain more than one drug. For example, the branded medications Celexa, Celapram and Citrol all contain the same active ingredient: citalopram; and the branded preparation Lemsip contains two active ingredients: paracetamol and phenylephrine.

Each drug’s INN is unique but may contain a word stem that is shared with other drugs of the same class, for example the beta blocker drugs propranolol and atenolol share the -olol suffix, and the benzodiazepine drugs lorazepam and diazepam share the -azepam suffix.

The WHO issues INNs in English, Latin, French, Russian, Spanish, Arabic, and Chinese, and a drug’s INNs are often cognate across most or all of the languages, with minor spelling or pronunciation differences, for example: “paracetamol” (en) “paracetamolum” (la), “paracétamol” (fr) and “парацетамол” (ru). An established INN is known as a recommended INN (rINN), while a name that is still being considered is called a proposed INN (pINN).

 

Name Stem examples are:[3]

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Drug Labeling

General Requirements for Prescription Drug Labeling

  • Summary for the safe and effective use of the drug
  • Informative and accurate
  • Not promotional, false, or misleading
  • No implied claims or suggestions for use if evidence of safety or effective is lacking
  • Based whenever possible on data derived from human experience

Highlights: Concise, one-half page summary of information in the Full Prescribing Information

  • Limitations Statement
  • Product Names and Date of Initial U.S. Approval
  • Boxed Warning
  • Recent Major Changes
  • Indications and Usage
  • Dosage & Administration
  • Dosage Forms & Strengths
  • Contraindications
  • Warnings & Precautions
  • Adverse Reactions (listing of most common ARs)
  • Drug Interactions
  • Use in Specific Populations
  • Patient Counseling Information Statement

 

Complete Physician Labelling Rules as listed in 21 CFR 201.56

Title 21Chapter ISubchapter CPart 201Subpart B → §201.56


Title 21: Food and Drugs
PART 201—LABELING
Subpart B—Labeling Requirements for Prescription Drugs and/or Insulin


§201.56   Requirements on content and format of labeling for human prescription drug and biological products.

(a) General requirements. Prescription drug labeling described in §201.100(d) must meet the following general requirements:

(1) The labeling must contain a summary of the essential scientific information needed for the safe and effective use of the drug.

(2) The labeling must be informative and accurate and neither promotional in tone nor false or misleading in any particular. In accordance with §§314.70 and 601.12 of this chapter, the labeling must be updated when new information becomes available that causes the labeling to become inaccurate, false, or misleading.

(3) The labeling must be based whenever possible on data derived from human experience. No implied claims or suggestions of drug use may be made if there is inadequate evidence of safety or a lack of substantial evidence of effectiveness. Conclusions based on animal data but necessary for safe and effective use of the drug in humans must be identified as such and included with human data in the appropriate section of the labeling.

(b) Categories of prescription drugs subject to the labeling content and format requirements in §§201.56(d) and 201.57. (1) The following categories of prescription drug products are subject to the labeling requirements in paragraph (d) of this section and §201.57 in accordance with the implementation schedule in paragraph (c) of this section:

(i) Prescription drug products for which a new drug application (NDA), biologics license application (BLA), or efficacy supplement was approved by the Food and Drug Administration (FDA) between June 30, 2001 and June 30, 2006;

(ii) Prescription drug products for which an NDA, BLA, or efficacy supplement is pending on June 30, 2006; or

(iii) Prescription drug products for which an NDA, BLA, or efficacy supplement is submitted anytime on or after June 30, 2006.

(2) Prescription drug products not described in paragraph (b)(1) of this section are subject to the labeling requirements in paragraph (e) of this section and §201.80.

(c) Schedule for implementing the labeling content and format requirements in §§201.56(d) and 201.57. For products described in paragraph (b)(1) of this section, labeling conforming to the requirements in paragraph (d) of this section and §201.57 must be submitted according to the following schedule:

(1) For products for which an NDA, BLA, or efficacy supplement is submitted for approval on or after June 30, 2006, proposed conforming labeling must be submitted as part of the application.

(2) For products for which an NDA, BLA, or efficacy supplement is pending on June 30, 2006, or that has been approved any time from June 30, 2005, up to and including June 30, 2006, a supplement with proposed conforming labeling must be submitted no later than June 30, 2009.

(3) For products for which an NDA, BLA, or efficacy supplement has been approved anytime from June 30, 2004, up to and including June 29, 2005, a supplement with proposed conforming labeling must be submitted no later than June 30, 2010.

(4) For products for which an NDA, BLA, or efficacy supplement has been approved anytime from June 30, 2003, up to and including June 29, 2004, a supplement with proposed conforming labeling must be submitted no later than June 30, 2011.

(5) For products for which an NDA, BLA, or efficacy supplement has been approved anytime from June 30, 2002, up to and including June 29, 2003, a supplement with proposed conforming labeling must be submitted no later than June 30, 2012.

(6) For products for which an NDA, BLA, or efficacy supplement has been approved anytime from June 30, 2001, up to and including June 29, 2002, a supplement with proposed conforming labeling must be submitted no later than June 30, 2013.

(d) Labeling requirements for new and more recently approved prescription drug products. This paragraph applies only to prescription drug products described in paragraph (b)(1) of this section and must be implemented according to the schedule specified in paragraph (c) of this section.

(1) Prescription drug labeling described in §201.100(d) must contain the specific information required under §201.57(a), (b), and (c) under the following headings and subheadings and in the following order:

Highlights of Prescribing Information

Product Names, Other Required Information

Boxed Warning

Recent Major Changes

Indications and Usage

Dosage and Administration

Dosage Forms and Strengths

Contraindications

Warnings and Precautions

Adverse Reactions

Drug Interactions

Use in Specific Populations

Full Prescribing Information: Contents

Full Prescribing Information

Boxed Warning

1 Indications and Usage

2 Dosage and Administration

3 Dosage Forms and Strengths

4 Contraindications

5 Warnings and Precautions

6 Adverse Reactions

7 Drug Interactions

8 Use in Specific Populations

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

8.4 Pediatric use

8.5 Geriatric use

9 Drug Abuse and Dependence

9.1 Controlled substance

9.2 Abuse

9.3 Dependence

10 Overdosage

11 Description

12 Clinical Pharmacology

12.1 Mechanism of action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 Nonclinical Toxicology

13.1 Carcinogenesis, mutagenesis, impairment of fertility

13.2 Animal toxicology and/or pharmacology

14 Clinical Studies

15 References

16 How Supplied/Storage and Handling

17 Patient Counseling Information

(2) Additional nonstandard subheadings that are used to enhance labeling organization, presentation, or ease of use (e.g., for individual warnings or precautions, or for each drug interaction) must be assigned a decimal number that corresponds to their placement in labeling. The decimal numbers must be consistent with the standardized identifying numbers listed in paragraph (d)(1) of this section (e.g., subheadings added to the “Warnings and Precautions” section must be numbered 5.1, 5.2, and so on).

(3) Any reference in Highlights to information appearing in the full prescribing information must be accompanied by the identifying number (in parentheses) corresponding to the location of the information in the full prescribing information.

(4) Omit clearly inapplicable sections, subsections, or specific information. If sections or subsections required under paragraph (d)(1) of this section are omitted from the full prescribing information, the heading “Full Prescribing Information: Contents” must be followed by an asterisk and the following statement must appear at the end of Contents: “* Sections or subsections omitted from the full prescribing information are not listed.”

(5) Any risk information that is required under §201.57(c)(9)(iv) is considered “appropriate pediatric contraindications, warnings, or precautions” within the meaning of section 505A(l)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355A(l)(2)), whether such information appears in the “Contraindications,” “Warnings and Precautions,” or “Use in Specific Populations” section of labeling.

(e) Labeling requirements for older prescription drug products. This paragraph applies only to approved prescription drug products not described in paragraph (b)(1) of this section.

(1) Prescription drug labeling described in §201.100(d) must contain the specific information required under §201.80 under the following section headings and in the following order:

Description

Clinical Pharmacology

Indications and Usage

Contraindications

Warnings

Precautions

Adverse Reactions

Drug Abuse and Dependence

Overdosage

Dosage and Administration

How Supplied

(2) The labeling may contain the following additional section headings if appropriate and if in compliance with §201.80(l) and (m):

Animal Pharmacology and/or Animal Toxicology

Clinical Studies

References

(3) Omit clearly inapplicable sections, subsections, or specific information.

(4) The labeling may contain a “Product Title” section preceding the “Description” section and containing only the information required by §201.80(a)(1)(i), (a)(1)(ii), (a)(1)(iii), and (a)(1)(iv) and §201.100(e). The information required by §201.80(a)(1)(i) through (a)(1)(iv) must appear in the “Description” section of the labeling, whether or not it also appears in a “Product Title.”

(5) The labeling must contain the date of the most recent revision of the labeling, identified as such, placed prominently immediately after the last section of the labeling.

(6) The requirement in §201.80(f)(2) to reprint any FDA-approved patient labeling at the end of prescription drug labeling or accompany the prescription drug labeling must be implemented no later than June 30, 2007.

[71 FR 3986, Jan. 24, 2006, as amended at 79 FR 72101, Dec. 4, 2014]