Exclusive: Eli Lilly supplied schizophrenia drug to uncertified healthcare providers, Form 483 shows

Eli Lil­ly shipped its schiz­o­phre­nia drug to un­cer­ti­fied phar­ma­cies and was not ad­her­ing to es­tab­lished safe­ty pro­ce­dures, the FDA found af­ter a Sep­tem­ber in­spec­tion at the com­pa­ny’s cor­po­rate of­fices in In­di­ana.

The agency not­ed five de­fi­cien­cies in­volv­ing Zyprexa Rel­prevv, in which the com­pa­ny did not fol­low the ap­proved Risk Eval­u­a­tion and Mit­i­ga­tion Strat­e­gy (REMS), a pro­gram for drugs with se­ri­ous safe­ty con­cerns, ac­cord­ing to a Form 483 ob­tained by End­points News through a FOIA re­quest.

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