PharmLaw Domain 4

Pharmacies must complete DEA Form 224 in order to register with the DEA, ,and this registration is to be renewed with the DEA every ______

3 years

True or false: Paper prescriptions (hard copy prescriptions) for C III, IV, and V may be kept with non-CS prescriptions ONLY IF the controlled prescriptions are marked with a RED “C” (for control) stamp of at least 1 inch in size

True

In general, records must be “readily retrievable” —> meaning the pharmacy can actually get it and provide it to the Board/inspector with in __________

48-72 hours

Federally, prescription records for CS must be kept _______

2 years minimum

True or false: because the drugs are not considered dispensed until the system provides them, drugs in the ADS are counted as pharmacy stock

True

There are many exceptions for e-prescribing, every state has basically the same exceptions: (6)

• Temporary technological failure (system is down)

• Prescription for a hospice patient

• Veterinarians are exempt

• An individual prescriber has a waiver

• Exceptional circumstances (emergencies)

  • Other random things

In general, can C-II prescriptions be issued by fax?

No

C-II prescriptions CAN be issued by fax in the following 3 circumstances:

1. The patient is a resident of a LTCF

2. The patient is in a hospice program

3. The drug is a narcotic to be compounded for direct patient administration (by a HCP)

True or false: Emergency kits are for emergency use only, strictly pursuant to order by a prescriber!

True

Can Emergency Kits contain CSs?

Yes, unless state law explicitly says otherwise

Does an emergency kit itself require a separate DEA registration?

No, if used appropriately, it is basically an extension of the pharmacy that provided it

True or false: STATE law may require the provider pharmacy to submit a separate application to the board for each emergency kit

True

Can an ADS/APD serve as an emergency kit?

Yes

Can central fill pharmacies fill CS and non-CS, as well as initial and/or refill prescriptions?

Yes

True or false: pharmacies must use “safety closure containers” (child-resistant packaging) unless the patient requests not to

True

In general the pharmacy may only be opened/closed (by key or code) by a _______, except in emergency situations

A pharmacist

If there is theft/loss of pseudoephedrine, pharmacies must notify DEA ________ “at the earliest practicable opportunity” and then file a written report within ________

ORALLY, 15 days

Pharmacy must keep a logbook (which may be electronic) of pseudoephedrine sales for _________ minimum

2 years

What must the logbook of pseudoephedrine sales contain in terms of information?

Purchaser’s name and address, product sold, quantity sold, date/time, and signature of the purchased that she/he understands the quantity limits and penalties of improper purchase

True or false: the purchaser of pseudoephedrine must present a valid government-issued photo ID

True

The max OTC pseudoephedrine quantity that can be sold to a person in 1 day is _____

3.6 g

The max OTC pseudoephedrine quantity that can be sold to a person in 30 days is ____

9g

Is there a federal requirement that the purchaser of pseudoephedrine must be 18 years old?

No - no federal law, although many states do have this requirement

In the event that the hospital pharmacy is closed but a drug is needed for a patient’s immediate needs, and unavailable elsewhere, the pharmacy director may…

Authorize 1 supervisory nurse (per shift) to enter the pharmacy to retrieve the drug(s) needed to serve the patient. The nurse must leave clear and thorough documentation for the pharmacist to review upon return.