Guidance for Industry

National Uniformity for Nonprescription Drugs —

Ingredient Listing for OTC Drugs

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

April 1998

Procedural Guidance #2
Guidance for Industry

National Uniformity for Nonprescription Drugs —

Ingredient Listing for OTC Drugs

Additional copies are available from:

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Rockville, MD 20857

(Tel) 301-827-4573

(Internet) http://www.fda.gov/cder/guidance/index.htm

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

April 1998

Procedural Guidance #2
This guidance has been prepared by the Regulations Policy Staff in the Center for Drug Evaluation and 1

Research (CDER) at the Food and Drug Administration (FDA). This guidance represents the Agency’s current thinking

on implementation of the Modernization Act’s amendments to section 502(e)(1) for OTC drug products. It does not

create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach

may be used if such approach satisfies the requirement of the applicable statute, regulations, or both.

GUIDANCE FOR INDUSTRY1

National Uniformity for Nonprescription Drugs —

 Ingredient Listing for OTC Drugs

I. INTRODUCTION

Section 412 of Title IV of the Food and Drug Administration Modernization Act of 1997 (the

Modernization Act), signed into law by President Clinton on November 21, 1997, amended

section 502(e) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 352(e)(1)) to

require that the established name and quantity (or, if determined to be appropriate, the

proportion) of each active ingredient appear on the label of all over-the-counter (OTC) drug

products intended for human use. 

In addition, section 502(e)(1), as amended by the Modernization Act, requires the listing of the

established name of each inactive ingredient on the outside container of the retail package and, if

determined to be appropriate by the Secretary, on the immediate container as well, as prescribed

in regulations promulgated by the Secretary. If the drug is an OTC drug that is not a cosmeticdrug, then the inactive ingredients must be listed in alphabetical order. These new requirements

regarding the listing of inactive ingredients do not apply to nonprescription drugs that are not

intended for human use.

This guidance is intended to clarify the administrative processes that will be followed in

implementing these amendments to section 502(e) of the Act as they apply to OTC drug products

for human use. 

II. FDA POLICY — ACTIVE INGREDIENTS

In the Federal Register of February 27, 1997 (62 FR 9024), FDA proposed a rule that would

establish a standardized format for the labeling of OTC drug products. The rule is intended to

make OTC drug product labeling easier to read and understand and will require the redesign of

OTC drug labels in accordance with a predetermined schedule of effective dates. The proposed

rule includes a standardized format for listing the name and the quantity per dosage unit (or, when

appropriate, the proportion) of each active ingredient. 
2

To minimize the burden faced by manufacturers, packers, and distributors dealing with labeling

changes, FDA advises that it does not intend to object if manufacturers, packers, and distributors

choose to defer relabeling their products to comply with the new requirement to list the quantity

of OTC active ingredients until no later than the earliest applicable implementation date as

specified in the Agency’s forthcoming final OTC labeling rule.

Full or abbreviated applications received after February 19, 1998, are expected to provide labels

or labeling listing the quantity of active ingredients in compliance with the requirements of the

Modernization Act.

III. FDA POLICY — INACTIVE INGREDIENTS

Section 502(e)(1)(iii) of the Federal Food, Drug, and Cosmetic Act, as amended by section

412(c) of the Modernization Act, states that a drug is misbranded unless its label bears "the

established name of each inactive ingredient listed in alphabetical order on the outside container of

the retail package and, if determined to be appropriate by the Secretary, on the immediate

container, as prescribed in regulations promulgated by the Secretary. . . ."

The Agency has received several letters since the signing of the Modernization Act from a trade

association representing nonprescription drug manufacturers asking whether the phrase "as

prescribed in regulations promulgated by the Secretary" modifies the entire provision, or only the

clause regarding the listing of inactive ingredients on the immediate container.

Consistent with what it believes to have been the intent of this provision, the Agency intends to

interpret both clauses — the clause for the listing of inactive ingredients on the outside container

and the clause for the listing of inactive ingredients on the immediate container — as requiring

implementing regulations before becoming effective. 

The final rule establishing a standard format for the labeling of OTC drug products based on the

proposed rule of February 27, 1997 (62 FR 9024), will provide the implementing regulations for

this requirement of the Modernization Act for OTC drug products. The FDA will consider, as

part of that rulemaking process, whether an additional opportunity for public comment is required

for any provisions in the final rule that are intended to implement section 502(e)(iii) as amended

by the Modernization Act.

This interpretation does not revoke or supersede in any way existing regulatory and statutory

requirements governing the labeling of inactive ingredients.