Essentials of Healthcare Product Labeling
33
Introduction
A product’s labeling presents the information
necessary for a product’s safe and effective
use. It is the culmination of drug development
and the essential element for drug approval.
Labeling approval by the US Food and Drug
Administration (FDA) signals the point at which
a new drug or biologic may be sold throughout
the US and its territories. Beyond its role as the
information component of a product, pharma-
ceutical labeling in the US has implications for
the product’s commercial success as well as global
influence and the potential for liability actions.
Labeling, therefore, attracts intense scrutiny
at the highest levels of company management
across many different functions, as well as from
interested parties outside the company.
Prevailing Laws and Authorities
Congress established authority for the regula-
tion of drugs through the Federal Food, Drug,
and Cosmetic Act (FD&C Act) from which
the FDA derives its oversight authority. Other
laws underlying the regulation of pharmaceutical
labeling are described in Table 5-1.1-10
In addition to the FDA, other agencies that
influence requirements for pharmaceutical label-
ing include the following:
• Drug Enforcement Agency (DEA): over-
sight of controlled substances3
• US Customs and Border Protection Agency:
country of origin labeling requirements for
substances manufactured (“substantially
transformed”) outside the US (19 CFR
134.11)11,12
• US Pharmacopoeia (USP): labeling
standards for the expression of purity
and potency, nomenclature, and package
warnings statements for certain products13
Prescription Medicines
As defined in the FD&C Act, the label of a
pharmaceutical product is the “display of written,
printed, or graphic matter upon the immedi-
ate container of any article.”1 Any information
required on the label also must appear on the
outer wrapper or container or be visible through
the container, if any. The FD&C Act defines the
broader term, labeling, as “all labels and other
written, printed, or graphic matter (1) upon any
article or any of its containers or wrappers, or (2)
Pharmaceutical
Labeling in the US
Cathleen O’Connell, PhD, MS, RPh, Susan Merchant,
Zahra Martinez, PharmD, RPh, and Jocelyn Jennings,
MS, RAC-US, RAC-Drugs, RAC-Devices, FRAPS
CHAPTER 5
33
Introduction
A product’s labeling presents the information
necessary for a product’s safe and effective
use. It is the culmination of drug development
and the essential element for drug approval.
Labeling approval by the US Food and Drug
Administration (FDA) signals the point at which
a new drug or biologic may be sold throughout
the US and its territories. Beyond its role as the
information component of a product, pharma-
ceutical labeling in the US has implications for
the product’s commercial success as well as global
influence and the potential for liability actions.
Labeling, therefore, attracts intense scrutiny
at the highest levels of company management
across many different functions, as well as from
interested parties outside the company.
Prevailing Laws and Authorities
Congress established authority for the regula-
tion of drugs through the Federal Food, Drug,
and Cosmetic Act (FD&C Act) from which
the FDA derives its oversight authority. Other
laws underlying the regulation of pharmaceutical
labeling are described in Table 5-1.1-10
In addition to the FDA, other agencies that
influence requirements for pharmaceutical label-
ing include the following:
• Drug Enforcement Agency (DEA): over-
sight of controlled substances3
• US Customs and Border Protection Agency:
country of origin labeling requirements for
substances manufactured (“substantially
transformed”) outside the US (19 CFR
134.11)11,12
• US Pharmacopoeia (USP): labeling
standards for the expression of purity
and potency, nomenclature, and package
warnings statements for certain products13
Prescription Medicines
As defined in the FD&C Act, the label of a
pharmaceutical product is the “display of written,
printed, or graphic matter upon the immedi-
ate container of any article.”1 Any information
required on the label also must appear on the
outer wrapper or container or be visible through
the container, if any. The FD&C Act defines the
broader term, labeling, as “all labels and other
written, printed, or graphic matter (1) upon any
article or any of its containers or wrappers, or (2)
Pharmaceutical
Labeling in the US
Cathleen O’Connell, PhD, MS, RPh, Susan Merchant,
Zahra Martinez, PharmD, RPh, and Jocelyn Jennings,
MS, RAC-US, RAC-Drugs, RAC-Devices, FRAPS
CHAPTER 5