Consumer Product Safety Improvement Act.
The Consumer Product Safety Improvement Act of 2008 (CPSIA) requires manufacturers
and importers of certain consumer products (including certain drug products)
manufactured on or after November 12, 2008, to certify that their products comply
with all applicable rules, bans, standards, or regulations enforced by the
Consumer Product Safety Commission (CPSC). Under the CPSIA, manufacturers and
importers must make available to customers a certificate specifying that the
product complies with the applicable CPSC rule, ban, standard, or regulation.
Such certification must be based on a test of each product or upon a reasonable
Otezla®is sold in special child-resistant packaging that must meet the requirements of the Poison Prevention Packaging Act. Accordingly, Amgen furnishes below links to the General Conformity Certificates for the product identified by corresponding finished drug product batch number.
2019 General Conformity Certificates identified by corresponding finished drug product batch number.
10 mg/20 mg/30 mg.
2020 General Conformity Certificate identified by corresponding finished drug product batch number.
For questions, please call Amgen Medical Information at 1-800-77AMGEN (1-800-772-6436).