SOLUTION VERIFIED
◉ CSOS digital certificate is valid until when? Answer: Until DEA
registration under which it is issued expires or until the CSOS CA is
notified that the certificate should be revoked
◉ Why would CSOS certificate be revoked? Answer: - certificate
holder is no longer authorized to sign schedule II orders for the
registrant
- if the information on which the certificate is based changes
- if digital certificate used to sign electronic orders has been
compromised, stolen, or lost
◉ Electronic order for controlled substances on CSOS may not be
filled if what? Answer: - required data fields not completed
- order not signed using a digital signature issued by DEA
- digital certificate has expired or been revoked prior to signature
- purchaser's public key will not validate the digital certificate
- validation of the order shows that the order is invalid for any
reason
,◉ If a DEA CSOS order cannot be filled, what must the supplier do?
Answer: Notify purchaser and provide statement as to the reason
(like impoperly prepared or altered)
◉ For CSOS orders, when must the supplier send a copy to the DEA?
Answer: within 2 business days
◉ A pharmacy cannot process electronic prescriptions for controlled
substances until ______________________________________ Answer: The
pharmacy application provider obtains a third party audit or
certification review that determines that the application complies
with DEA's requirements and the application provider provides the
audit/certification report to the pharmacy
◉ What is a 2-factor authentication? Answer: - Prescribers must use
this to write prescriptions for controlled substances
- Must have 2 of the following: something you know (i.e. password),
something you have (i.e. a hard token stored separately from the
computer being accessed), and something you are (biometric ID)
◉ What act was instated to amend the CSA to prevent illegal
distribution of controlled substances on the internet? Answer: Ryan
Haight Online Pharmacy Consumer Protection Act
,◉ What did the Ryan Haight Act do? Answer: - Requires online
pharmacies to get a modification of existing DEA registration to
allow for operation of an online pharmacy
◉ Online pharmacies must register with the DEA ____ days prior to
engaging in internet pharmacy involving controlled substances
Answer: 30 days
◉ What are the 2 exemptions to the definition of "online pharmacy"?
Answer: - Pharmacies registered with the DEA whose dispensing of
controlled substances via the internet consist solely of refilling
prescriptions for CS in C-III thru V
- Filling new prescriptions in C-II thru V where the pharmacy had
previously filled a non-internet prescription for the same patient
and at the patient's request contacts the prescriber for a new
prescription
◉ What 6 statements must be put on an online pharmacy's home
page? Answer: - Pharmacy complies with the Act
- Name, address, email addresses, and phone number of the
pharmacy
- Name, professional degree, and states of licensure for the PIC as
well as a phone number for the PIC
- List of states where the pharmacy is licensed
, - Certification that the pharmacy is registered with the DEA as an
online pharmacy
- Name, address, phone number, professional degree, and states of
licensure of any practitioner that has a contractual relationship with
the pharmacy
◉ What is a monthly reporting requirement for online pharmacies?
Answer: Must report to DEA on a monthly basis, the quantity of each
CS dispensed by the pharmacy if they dispense at least 100
prescriptions or at least 5000 dosage units/month
◉ What accreditation is available for online pharmacies and who
supplies it? What does it do? Answer: - Verified Internet Pharmacy
Practice Site (VIPPS) accreditation from NABP
- Legitimizes the pharmacy from other rogue online pharmacies and
allows the website to have a .pharmacy domain instead of .com
◉ Who is responsible for reporting in-transit loss of controlled
substances? Answer: Supplier (purchaser is only responsible after
they receive and sign for the order)
◉ What form must be submitted if an in-transit loss or theft is
realized after a purchaser signs for a controlled order? Answer: DEA
Form 106