Dear Team,
I would like to receive some knowledge for the following question.
Lary: Repackager
Elaine: Manufactured by
Alan: Manufactured for and Distributed by
Tom: Distributed by
Bulk NDC: 12345-678-**
100ct bottle NDC: 12345-678-01
10x10 blister NDC: 00000-123-70
Lary is contracted by Alan to repackage controlled substance product bulk (mfg by Elaine) into a 100ct bottle and will be commercialized. The NDC for 100ct bottle is 12345-678-01. That NDC is also Elaine's bulk NDC. 222 is involved for the transaction from Elaine to Lary.
Tom buys Alan's bulk 100ct bottle and have Lary to repackage it into 10x10 blister, NDC 00000-123-70, which will be commercialized. The product will not be physically moved since Lary is the same contracted repackager for both Alan and Tom. Does Lary need to issue to Lary a 222 at this stage (for the ownership exchange)? Or a Transfer of Ownership form would suffice the DEA requirements?
Any feedback is much appreciated!
Thanks,
Trish
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Trisha Nguyen
RA Specialist, II
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