2013 NDNL Questions
Number Question
Notes
13-1
 Specifically, what differentiates “manufacturing”
from “compounding” in the FD&C Act and WA
law?
 What are the requirements for non-sterile versus
sterile compounding in Washington.
 What are the appropriate standards for
ingredients and other components used in
compounding? How do these requirements
differ from FDA’s Compliance Policy Guide?
 What are the limitations on distribution of
compounded products?
13-2
Under what circumstances may a pharmacy sell OTC,
legend or controlled substances to another pharmacy?
To a practitioner for office use? May partial containers
be “sold”? Are there quantity or financial restrictions?
How do legend vs. controlled substances differ?
13-3
What are the boundaries on technician, assistant or
pharmacy intern utilization in in-patient versus outpatient practice settings? How does the use of each
impact pharmacy licensure? What are the requirements
for a “utilization plan”?
13-4
What are the limitations for number of prescriptions on a
Schedule II prescription form?
13-6
Under what circumstances may a drug intended for
human use be dispensed for veterinary use?
13-7
May veterinarians compound “secret formulations” for
use on their clients in WA?
13-9
In satisfying DEA’s interpretation of CSA and
promulgated regulations, who are and are not
practitioner’s agents when preparing prescriptions for
signature?
13-10
What are pharmacist as prescriber boundaries under
collaborative practice agreements? For instance,
 Are there parallel responsibilities to those that
the practitioner would normally complete?
 Must a pharmacist practicing under a
collaborative agreement be employed by a
licensed pharmacy?
12-13
Prepare a chart showing the number of refills (or
multiple prescriptions for the same drug) allowed for
legend, C-III - C-V drugs. Include columns to show DEA
vs. Washington requirements, duration, day's supply and
quantity restrictions. Contrast with DEA's "multiple
prescriptions" requirements for C-IIs.
Contrast single-prescription versus multiple-prescription
C-II prescriptions.
Page 1 of 2
2013 NDNL Questions
Number Question
12-14
When may a pharmacist partially fill a Schedule II
prescription?
When a pharmacist is only able to provide a partial
quantity of a Schedule II prescription, how long does
s/he have to provide the remaining quantity?
Differentiate between community, long-term care, adult
family home and hospice
12-37
Under what circumstances may a pharmacist fill
prescriptions written in another state or country?
Include prescriptive authority considerations. What
documentation is necessary?
12-47
What wording is required under the signature lines of
prescriptions in Washington?
•
How is this requirement satisfied for
electronically transmitted prescriptions?
•
What are the specific compliance elements for
“tamper-resistant prescription pads”?
•
Contrast hard-copy vs. electronic prescriptions.
•
Computer generated FAXes
•
Are “electronic signatures” permitted?
•
Are TRP's required if the Rx is from an out of
state practitioner?
•
What if the out of state prescription is for a
Medicaid patient?
DEA Number verification
Page 2 of 2
Notes