Essentials of Healthcare Product Labeling
37
enhance the safe and effective use of prescription
drug products and reduce the number of adverse
reactions resulting from medication errors due
to misunderstood or incorrectly applied drug
information.”16
The PLR format consists of three main
elements:
• Highlights, a succinct description of the
most important information for healthcare
professionals
• Table of contents and
• Labeling details presented in numbered
sections of the Full Prescribing Information
(FPI).
Additionally, provisions of the 2006 rule that
apply to all products, whether or not the pre-
scribing information is required to follow PLR
format, mandate that any FDA-approved patient
labeling (such as a Medication Guide or Patient
Package Insert) either accompany the prescrib-
ing information or be printed following the last
section of the prescribing information.16,31
Labeling for any new prescription drugs
and biologics’ applications, and any that were
approved since June 2001, must conform to the
PLR (21 CFR 201.57) requirements (see Table
5-332). However, as permitted by the PLR imple-
mentation plan, some older products still may
carry prescribing information in the previous
format, as described in 21 CFR 201.80.31
The PLR was one component of a broad
FDA initiative to improve prescription medi-
cine information for healthcare professionals.
The agency also issued guidances to facilitate
compliance with labeling regulations for most
prescribing information sections to help sponsors
develop labeling that will be useful to healthcare
professionals.
Table 5-2. Required Elements for Container Labels of Prescription Drugs and Biologicsa,1,13,23-30
Labeled Element Regulation(s)
Name and address of manufacturer, packer, distributor 21 CFR 201.1 23 610.0, 610.6424
National Drug Code (requested, not required) 21 CFR 201.223
Statement of ingredients, quantity and proportion 21 CFR 201.10, 10023
Lot number 21 CFR 201.18 610.6023,24
Expiration date 21 CFR 201.17, 211.137 23 610.60 24 ICH Q1A(R2) Section
2.2.1025,26
Storage conditions 21 CFR 205.50 27 610.60 28 USP-NF,13 ICH Q10A(R2)
Section 2.2.1025
Bar code 21 CFR 201.2523
Statement of identity (established name) 21 CFR 201.10, 50 23 610.6024
Declaration of net quantity of contents, strength 21 CFR 201.5123
Recommended dosage 21 CFR 201.55, 100 23 610.6024
Route of administration (if not oral) 21 CFR 201.10023
Country of origin (if different from the US) 19 CFR 134.1129
“Rx only” 21 CFR 201.100 30 610.6028
Directions specifying type of container to be used in
dispensing
21 CFR 201.10023
Product identifier Food, Drug, and Cosmetic Act Subchapter 8 –
Pharmaceutical Distribution Supply Chain (§581 and §582)1
a See 21 CFR 606.120 and 121, 610.67 for requirements for blood products.
37
enhance the safe and effective use of prescription
drug products and reduce the number of adverse
reactions resulting from medication errors due
to misunderstood or incorrectly applied drug
information.”16
The PLR format consists of three main
elements:
• Highlights, a succinct description of the
most important information for healthcare
professionals
• Table of contents and
• Labeling details presented in numbered
sections of the Full Prescribing Information
(FPI).
Additionally, provisions of the 2006 rule that
apply to all products, whether or not the pre-
scribing information is required to follow PLR
format, mandate that any FDA-approved patient
labeling (such as a Medication Guide or Patient
Package Insert) either accompany the prescrib-
ing information or be printed following the last
section of the prescribing information.16,31
Labeling for any new prescription drugs
and biologics’ applications, and any that were
approved since June 2001, must conform to the
PLR (21 CFR 201.57) requirements (see Table
5-332). However, as permitted by the PLR imple-
mentation plan, some older products still may
carry prescribing information in the previous
format, as described in 21 CFR 201.80.31
The PLR was one component of a broad
FDA initiative to improve prescription medi-
cine information for healthcare professionals.
The agency also issued guidances to facilitate
compliance with labeling regulations for most
prescribing information sections to help sponsors
develop labeling that will be useful to healthcare
professionals.
Table 5-2. Required Elements for Container Labels of Prescription Drugs and Biologicsa,1,13,23-30
Labeled Element Regulation(s)
Name and address of manufacturer, packer, distributor 21 CFR 201.1 23 610.0, 610.6424
National Drug Code (requested, not required) 21 CFR 201.223
Statement of ingredients, quantity and proportion 21 CFR 201.10, 10023
Lot number 21 CFR 201.18 610.6023,24
Expiration date 21 CFR 201.17, 211.137 23 610.60 24 ICH Q1A(R2) Section
2.2.1025,26
Storage conditions 21 CFR 205.50 27 610.60 28 USP-NF,13 ICH Q10A(R2)
Section 2.2.1025
Bar code 21 CFR 201.2523
Statement of identity (established name) 21 CFR 201.10, 50 23 610.6024
Declaration of net quantity of contents, strength 21 CFR 201.5123
Recommended dosage 21 CFR 201.55, 100 23 610.6024
Route of administration (if not oral) 21 CFR 201.10023
Country of origin (if different from the US) 19 CFR 134.1129
“Rx only” 21 CFR 201.100 30 610.6028
Directions specifying type of container to be used in
dispensing
21 CFR 201.10023
Product identifier Food, Drug, and Cosmetic Act Subchapter 8 –
Pharmaceutical Distribution Supply Chain (§581 and §582)1
a See 21 CFR 606.120 and 121, 610.67 for requirements for blood products.