Chapter 5: Pharmaceutical Labeling in the US
38 Regulatory Affairs Professionals Society (RAPS)
Table 5-3. Required Sections of Prescribing Information for Drugs and Biologics in the US
(PLR Format)32
Element Sections 21 CFR 201.57
Highlights of Prescribing
Information
Highlights limitation statement
Drug names, dosage form, route of administration, controlled substance
symbol (if needed)
Initial US approval
Boxed warning (if any)
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
Patient counseling information statement
Revision date
201.57(a)
Full Prescribing Information Contents (table of contents) 201.57(b)
Full Prescribing Information Boxed warning (if any) 201.57(c)(1)
1 Indications and usage 201.57(c)(2)
2 Dosage and administration 201.57(c)(3)
3 Dosage forms and strengths 201.57(c)(4)
4 Contraindications 201.57(c)(5)
5 Warnings and precautions 201.57(c)(6)
6 Adverse reactions 201.57(c)(7)
7 Drug interactions 201.57(c)(8)
8 Use in specific populations 201.57(c)(9)
8.1 Pregnancy 201.57(c)(9)(i)
8.2 Lactation 201.57(c)(9)(ii)
8.3 Females and males of reproductive potential 201.57(c)(9)(iii)
8.4 Pediatric use 201.57(c)(9)(iv)
8.5 Geriatric use 201.57(c)(9)(v)
9 Drug abuse and dependence 201.57(c)(10)
9.1 Controlled substance (if scheduled) 201.57(c)(10)(i)
9.2 Abuse 201.57(c)(10)(ii)
9.3 Dependence 201.57(c)(10)(iii)
10 Overdosage 201.57(c)(11)
11 Description 201.57(c)(12)
12 Clinical pharmacology 201.57(c)(13)(i)
12.1 Mechanism of action 201.57(c)(13)(i)(A)
12.2 Pharmacodynamics 201.57(c)(13)(i)(B)
12.3 Pharmacokinetics 201.57(c)(13)(i)(C)
13 Nonclinical toxicology 201.57(c)(14)
13.1 Carcinogenesis, mutagenesis, impairment of fertility 201.57(c)(14)(i)
13.2 Animal toxicology and/or pharmacology 201.57(c)(14)(ii)
14 Clinical studies 201.57(c)(15)
15 References 201.57(c)(16)
16 How supplied/storage and handling 201.57(c)(17)
17 Patient counseling information 201.57(c)(18)
38 Regulatory Affairs Professionals Society (RAPS)
Table 5-3. Required Sections of Prescribing Information for Drugs and Biologics in the US
(PLR Format)32
Element Sections 21 CFR 201.57
Highlights of Prescribing
Information
Highlights limitation statement
Drug names, dosage form, route of administration, controlled substance
symbol (if needed)
Initial US approval
Boxed warning (if any)
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
Patient counseling information statement
Revision date
201.57(a)
Full Prescribing Information Contents (table of contents) 201.57(b)
Full Prescribing Information Boxed warning (if any) 201.57(c)(1)
1 Indications and usage 201.57(c)(2)
2 Dosage and administration 201.57(c)(3)
3 Dosage forms and strengths 201.57(c)(4)
4 Contraindications 201.57(c)(5)
5 Warnings and precautions 201.57(c)(6)
6 Adverse reactions 201.57(c)(7)
7 Drug interactions 201.57(c)(8)
8 Use in specific populations 201.57(c)(9)
8.1 Pregnancy 201.57(c)(9)(i)
8.2 Lactation 201.57(c)(9)(ii)
8.3 Females and males of reproductive potential 201.57(c)(9)(iii)
8.4 Pediatric use 201.57(c)(9)(iv)
8.5 Geriatric use 201.57(c)(9)(v)
9 Drug abuse and dependence 201.57(c)(10)
9.1 Controlled substance (if scheduled) 201.57(c)(10)(i)
9.2 Abuse 201.57(c)(10)(ii)
9.3 Dependence 201.57(c)(10)(iii)
10 Overdosage 201.57(c)(11)
11 Description 201.57(c)(12)
12 Clinical pharmacology 201.57(c)(13)(i)
12.1 Mechanism of action 201.57(c)(13)(i)(A)
12.2 Pharmacodynamics 201.57(c)(13)(i)(B)
12.3 Pharmacokinetics 201.57(c)(13)(i)(C)
13 Nonclinical toxicology 201.57(c)(14)
13.1 Carcinogenesis, mutagenesis, impairment of fertility 201.57(c)(14)(i)
13.2 Animal toxicology and/or pharmacology 201.57(c)(14)(ii)
14 Clinical studies 201.57(c)(15)
15 References 201.57(c)(16)
16 How supplied/storage and handling 201.57(c)(17)
17 Patient counseling information 201.57(c)(18)