Chapter 5: Pharmaceutical Labeling in the US
54 Regulatory Affairs Professionals Society (RAPS)
84. Martin IG. Electronic labeling: a paperless future?
Drug Information Journal. 1998 32:917-919.
85. Food and Drug Administration. Electronic Distribution
of Prescribing Information for Human Prescription
Drugs, Including Biological Products, Proposed
Rule, 79 Fed. Reg. 75506. Dated 18 December 2014.
Accessed 31 August 2023. https://www.govinfo.gov/
content/pkg/FR-2014-12-18/pdf/2014-29522.pdf
86. US Government Accountability Office. Report to
Congressional Committees: Electronic drug labeling –
no consensus on the advantages and disadvantages of
its exclusive use. Dated July 2013. Accessed 31 August
2023. https://www.gao.gov/assets/660/655760.pdf
87. US Congress. House Appropriations Committees
Significant Items House Committee Report. Item 44
Prescription drug labeling inserts. Dated 26 April 2016.
Accessed 6 November 2023. https://www.govinfo.
gov/content/pkg/CRPT-114hrpt531/pdf/CRPT-
114hrpt531.pdf
88. Office of Management and Budget – Office of
Information and Regulatory Affairs. Electronic
Distribution of Prescribing Information for Human
Prescription Drugs Including Biological Products
(RIN 0910-AG18). Published Spring 2019. Accessed
31 August 2023. https://www.reginfo.gov/public/do/
eAgendaViewRule?pubId=201904&RIN=0910-AG18
54 Regulatory Affairs Professionals Society (RAPS)
84. Martin IG. Electronic labeling: a paperless future?
Drug Information Journal. 1998 32:917-919.
85. Food and Drug Administration. Electronic Distribution
of Prescribing Information for Human Prescription
Drugs, Including Biological Products, Proposed
Rule, 79 Fed. Reg. 75506. Dated 18 December 2014.
Accessed 31 August 2023. https://www.govinfo.gov/
content/pkg/FR-2014-12-18/pdf/2014-29522.pdf
86. US Government Accountability Office. Report to
Congressional Committees: Electronic drug labeling –
no consensus on the advantages and disadvantages of
its exclusive use. Dated July 2013. Accessed 31 August
2023. https://www.gao.gov/assets/660/655760.pdf
87. US Congress. House Appropriations Committees
Significant Items House Committee Report. Item 44
Prescription drug labeling inserts. Dated 26 April 2016.
Accessed 6 November 2023. https://www.govinfo.
gov/content/pkg/CRPT-114hrpt531/pdf/CRPT-
114hrpt531.pdf
88. Office of Management and Budget – Office of
Information and Regulatory Affairs. Electronic
Distribution of Prescribing Information for Human
Prescription Drugs Including Biological Products
(RIN 0910-AG18). Published Spring 2019. Accessed
31 August 2023. https://www.reginfo.gov/public/do/
eAgendaViewRule?pubId=201904&RIN=0910-AG18