Essentials of Healthcare Product Labeling
41
subsection is to be presented in the follow-
ing order: Pregnancy Exposure Registry,
Risk Summary, Clinical Considerations, and
Data.
• Lactation replaced Nursing Mothers.
This new subsection presents information
relating to the presence of the drug in milk,
effects on milk production, and risks to the
breast-feeding child, along with recom-
mendations on minimizing exposure and
mitigating adverse effects. Information in
this subsection is to be presented in the
following order: Risk Summary, Clinical
Considerations, and Data.
• The PLLR introduced a new subsec-
tion, Females and Males of Reproductive
Potential, when necessary, to assist
healthcare professionals in locating recom-
mendations relating to pregnancy testing,
contraception recommendations, and infer-
tility information.
Both the Pregnancy and Lactation subsections
should describe the underlying data.
Pregnancy categories (A, B, C, D, X) had
been in use in prescription labeling since 1979 to
convey distinctions in reproductive and develop-
mental adverse effects in terms of available risk
evidence. This system was limited in its ability
to communicate distinctions among levels of
risk, leading to confusion among healthcare
professionals and misinterpretation for clini-
cal decisions. The PLLR rule eliminated these
categories in favor of a narrative structure for
pregnancy labeling to describe drug exposure
risks and the data on which the information is
based to provide more meaningful information
for healthcare providers.
Current and comprehensive information
is available on the Pregnancy and Lactation
Labeling (Drugs) Final Rule page on the FDA’s
website.49
Drug Abuse and Dependence
This section is included in the prescribing infor-
mation of all medicines with a potential for abuse
or dependence, not limited to those regulated
under the Controlled Substances Act. If it is a
drug controlled by the DEA, its schedule will be
noted (e.g., Schedule II).
In a guidance issued for comment in July
2019,50 the FDA noted the drug abuse and
dependence section should concisely present
information about “a drug’s potential for abuse,
misuse, addiction, physical dependence and
tolerance” and for its safe and effective use in
treatment. As specified in the regulations (21
Figure 5-1. Prescription Drug Labeling Sections 8.1–8.3 (Use in Specific Populations)49
41
subsection is to be presented in the follow-
ing order: Pregnancy Exposure Registry,
Risk Summary, Clinical Considerations, and
Data.
• Lactation replaced Nursing Mothers.
This new subsection presents information
relating to the presence of the drug in milk,
effects on milk production, and risks to the
breast-feeding child, along with recom-
mendations on minimizing exposure and
mitigating adverse effects. Information in
this subsection is to be presented in the
following order: Risk Summary, Clinical
Considerations, and Data.
• The PLLR introduced a new subsec-
tion, Females and Males of Reproductive
Potential, when necessary, to assist
healthcare professionals in locating recom-
mendations relating to pregnancy testing,
contraception recommendations, and infer-
tility information.
Both the Pregnancy and Lactation subsections
should describe the underlying data.
Pregnancy categories (A, B, C, D, X) had
been in use in prescription labeling since 1979 to
convey distinctions in reproductive and develop-
mental adverse effects in terms of available risk
evidence. This system was limited in its ability
to communicate distinctions among levels of
risk, leading to confusion among healthcare
professionals and misinterpretation for clini-
cal decisions. The PLLR rule eliminated these
categories in favor of a narrative structure for
pregnancy labeling to describe drug exposure
risks and the data on which the information is
based to provide more meaningful information
for healthcare providers.
Current and comprehensive information
is available on the Pregnancy and Lactation
Labeling (Drugs) Final Rule page on the FDA’s
website.49
Drug Abuse and Dependence
This section is included in the prescribing infor-
mation of all medicines with a potential for abuse
or dependence, not limited to those regulated
under the Controlled Substances Act. If it is a
drug controlled by the DEA, its schedule will be
noted (e.g., Schedule II).
In a guidance issued for comment in July
2019,50 the FDA noted the drug abuse and
dependence section should concisely present
information about “a drug’s potential for abuse,
misuse, addiction, physical dependence and
tolerance” and for its safe and effective use in
treatment. As specified in the regulations (21
Figure 5-1. Prescription Drug Labeling Sections 8.1–8.3 (Use in Specific Populations)49