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Click ‘Get Form’ to open the Prescription Drug Pedigree in our editor.
Begin by entering the wholesaler’s name at the top of the form. This identifies who is completing the pedigree.
Fill in the drug details, including the Legend Drug Name, Strength, Dosage Form, and Container Size. If applicable, check the box indicating that this is a repackaged drug.
Provide optional NDC information and complete the Reference Number, Lot Number, Quantity, Unique Serial #, Document Type, and Reference Date related to the sale.
In the Ownership History section, input details about the manufacturer and any wholesalers involved in previous transactions. Ensure to include names, addresses, dates purchased, and signatures where required.
Complete all necessary fields for each transaction listed under Physical Distribution History. Repeat as needed for additional sales.
Finally, sign and date at the bottom of the form to affirm that all information is accurate and complete.
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A product pedigree describes its design and how it was built and shows that it was built in accordance with the drawings and other documentation defining the product configuration. Evaluating the pedigree of a failed product can help to rule in or rule out hypothesized failure causes.
What is meant by pedigree?
(PEH-dih-gree) A diagram of family history that uses standardized symbols. A pedigree shows relationships between family members and indicates which individuals have certain genetic pathogenic variants, traits, and diseases within a family as well as vital status.
What is a pedigree statement?
Pedigree means a statement or record in a written form or electronic form, approved by the board, that records each wholesale distribution of any given prescription drug (excluding veterinary prescription drugs), which leaves the normal distribution channel.
What is a pedigree in pharma?
A drug pedigree is a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to them.
Is there a $2000 cap on prescription drugs for seniors?
Pedigree documentation is like your dogs birth certificate. It holds critical information about your dogs lineage, helping you understand not only where your dog comes from but also crucial details about their health and genetics.
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Prescription drug pedigree examplePrescription drug pedigree templatePrescription drug pedigree pdfSection 582 of the FD&C ActDSCSA21 U.S.C. 360eee-1Drug supply chain Security ActDSCSA requirements for pharmacies
Related links
The R.F.I.D. Act of 2006 and E-Pedigrees
by S Ghosh 2007 Cited by 14 e-pedigree solution for all prescription drug products, but RFID costs will drop as use increases. Pharmaceutical companies can justify RFID costs because
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