“The Trump Administration wants to start a drug-importation program from Canada for both small-molecule and biologic products. The program would be a “time-limited Section 804 importation program” (SIP), with the SIP program sponsored by “a pharmacist, a wholesaler, or another State or non-federal governmental entity” and subject to FDA review. Additional language in the notice of proposed rulemaking (NPRM) gives guidance on how manufacturers themselves could set up reimportation. The NPRM is available in draft form today (Dec. 18), and is expected to be published officially in the Federal Register on Dec. 23.”
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California Designated Representative Online Training for Drug/Device Wholesalers
Heavy Phone Call Volume at The California State Board of Pharmacy Office
According to an email sent by the Board (dated July 22, 2019):
“The Board of Pharmacy is currently experiencing heavy call volume. If you are not able to reach staff by phone, please email us. Visit the Contact Us page on the board’s website, www.pharmacy.ca.gov., for an email address related to your concern.
The board’s main phone number is (916) 518-3100. Staff is available 8 a.m. to 5 p.m. Monday through Friday. Thank you for your patience and understanding.”
“Question: I need to take a California Designated Representative training course. What kind of topics will be covered in an approved training program?
Answer: It depends on the kind of California Designated Representative license type you are applying for. In other words, the required topics are different for the wholesaler, third-party logistics provider (3PL), and reverse distributor. . . .”
“A designated representative is an individual who performs clerical, inventory control, housekeeping, delivery, maintenance, or similar functions related to the distribution or dispensing of dangerous drugs or dangerous devices. To work as a designated representative, you must possess and keep a current certificate as a designated representative.”