Subject: | |
From: | |
Reply To: | |
Date: | Wed, 3 Dec 2014 19:32:09 +0000 |
Content-Type: | text/plain |
Parts/Attachments: |
|
|
The FDA has been looking at this for a long time. They have finally released the final rule for pregnancy & lactation in the package inserts. But there is time as the rule will not take effect until June 30, 2015 for new drugs. For old (existing on the market) drugs it will happen over time.
The FDA published a final rule today (12/3/2014) that sets standards on changes to pregnancy and lactation labeling information for prescription drug and biological products. The final rule replaces the current product letter categories – A, B, C, D and X – used to classify the risks of using prescription drugs during pregnancy with three detailed subsections that describe risks within the real-world context of caring for pregnant women who may need medication.
The rule finalizes many of the provisions in the proposed rule that the FDA issued in May 2008, and will be in effect as of June 30, 2015. Once the final rule is in effect, newly approved drug and biological product applications will be required to use the new format immediately, while the new labeling content and format requirements for previously approved products subject to the Physician Labeling Rule will be phased in gradually. FDA press release: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm425317.htm Final rule (Federal Register): https://www.federalregister.gov/articles/2014/12/04/2014-28241/pregnancy-and-lactation-labeling-requirements-content-and-format-of-labeling-for-human-prescription
Frank J. Nice, RPh, DPA, CPHP
***********************************************
Archives: http://community.lsoft.com/archives/LACTNET.html
To reach list owners: [log in to unmask]
Mail all list management commands to: [log in to unmask]
COMMANDS:
1. To temporarily stop your subscription write in the body of an email: set lactnet nomail
2. To start it again: set lactnet mail
3. To unsubscribe: unsubscribe lactnet
4. To get a comprehensive list of rules and directions: get lactnet welcome
|
|
|