United States Government Publishing Office
publisher
pbl
distributor
dst
United States
National Archives and Records Administration
Office of the Federal Register
author
aut
Government Organization
text
government publication
eng
FR
Regulatory Information
2019_register
executive
2019-05-31
article
Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain; Establishment of a Public Docket; Request for Comments
Notices
D09002ee1c162f7ec
D09002ee1c162f866
United States
Department of Health and Human Services
originator
org
United States Government Agency or Subagency
United States
Food and Drug Administration
originator
org
United States Government Agency or Subagency
The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket to solicit public comment on a potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) to require that certain solid, oral dosage forms of immediate-release (IR) opioid analgesics commonly prescribed for treatment of acute pain be made available in fixed- quantity unit-of-use blister packaging for outpatient dispensing. This could reduce the amount of unused opioid analgesics, thereby reducing opportunities for misuse, abuse, inappropriate access, and overdose, and possibly reducing the development of new opioid addiction.
84 FR 25283
https://www.govinfo.gov/app/details/FR-2019-05-31/2019-11283
2019-11283
fr31my19-71
4164-01-P
Docket No. FDA-2019-N-1845
https://www.govinfo.gov/app/details/FR-2019-05-31/2019-11283
https://www.govinfo.gov/content/pkg/FR-2019-05-31/html/2019-11283.htm
https://www.govinfo.gov/content/pkg/FR-2019-05-31/pdf/2019-11283.pdf
7 p.
25283
25289
84 FR 25283
Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain; Establishment of a Public Docket; Request for Comments; Federal Register Vol. 84, Issue
NOTICE
2019-11283
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2019-07-30
Docket No. FDA-2019-N-1845
4164-01-P
2019-11283
Notice; establishment of a public docket; request for comments.
The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket to solicit public comment on a potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) to require that certain solid, oral dosage forms of immediate-release (IR) opioid analgesics commonly prescribed for treatment of acute pain be made available in fixed- quantity unit-of-use blister packaging for outpatient dispensing. This could reduce the amount of unused opioid analgesics, thereby reducing opportunities for misuse, abuse, inappropriate access, and overdose, and possibly reducing the development of new opioid addiction.
Submit either electronic or written comments by July 30, 2019.
Patrick Raulerson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6260, Silver Spring, MD 20993, 301-796- 3522, Patrick.Raulerson@fda.hhs.gov.
Establishment of a Public Docket:
Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain
,
Patrick.Raulerson@fda.hhs.gov
http://dx.doi.org/10.15585/mmwr.mm675152e1
http://michigan-open.org/emergency-department-prescribing-recommendations/
https://mha.ohio.gov/Portals/0/assets/Initiatives/GCOAT/Guidelines-ED-Acute-Care.pdf
https://opioidprescribing.info/
https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-Aug-2017.pdf
https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM626666.pdf
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
https://www.samhsa.gov/data/
https://www1.nyc.gov/assets/doh/downloads/pdf/basas/opioid-prescribing-guidelines.pdf
www.hcup-us.ahrq.gov/reports/statbriefs/sb223-Ambulatory-Inpatient-Surgeries-2014.pdf
Federal Register
Vol. 84, no. 105
Office of the Federal Register, National Archives and Records Administration
2019-05-31
continuing
daily
deposited
born digital
330 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2019-05-31
P0b002ee1a13d60ed
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr31my19
https://www.govinfo.gov/app/details/FR-2019-05-31
https://www.govinfo.gov/content/pkg/FR-2019-05-31/pdf/FR-2019-05-31.pdf
https://www.govinfo.gov/content/pkg/FR-2019-05-31/xml/FR-2019-05-31.xml
fdlp
25173
25492
DGPO
2019-05-31
2023-10-04
FR-2019-05-31
machine generated
eng
FR
FR-2019-05-31
84
105