Law - Exam II - 3
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When can a drug be returned from a community medical center and redispensed?
- (a) The decision to accept delivery of the drug or device for relabeling and redispensing rests solely with the contracting pharmacist or pharmacy;
- (b) The drug or device has been in the control of the community health center at all times;
- (c) The drug or device is in the original and unopened labeled container with a tamper-evident seal intact. Such container shall bear the expiration date or calculated expiration date and lot number; and
- (d) The relabeling and redispensing is not otherwise prohibited by law.
Any person or entity, including, but not limited to, an immunosuppressant drug manufacturer or transplant center, may donate immunosuppressant drugs to a participant or return previously prescribed immunosuppressant drugs to the transplant center where_______________________________.
they were originally prescribed
____________________________________________________ may donate immunosuppressant drugs to a participant or return previously prescribed immunosuppressant drugs to the transplant center where they were originally prescribed.
Any person or entity, including, but not limited to, an immunosuppressant drug manufacturer or transplant center
It is important to note, that at this time Department of Correctional Services facilities, detention facilities, or jails cannot return drugs for credit or relabeling and redispensing, until_____________________________________________.
the Jail Standards Board, in consultation with the Board of Pharmacy, adopts and promulgates rules and regulations relating to such returns
In Nebraska, a drug or device DISPENSED under what conditions cannot be returned or redistributed?
Dispensed to an ambulatory patient from a chain community pharmacy, independent community pharmacy, outpatient hospital pharmacy or to patients in an assisted living facility in Nebraska
When can a controlled substance be accepted for return and/or redispensed to other patients?
Can a prescription that has been filled and not picked up by the patient (i.e., not dispensed), be returned to stock?
Yes, as long as lot numbers and expiration dates are not mixed in your inventory. The mixing of lot numbers and expiration dates in your inventory is considered misbranding in most situations
In Nebraska, it is it acceptable to leave the drug in the prescription container on a shelf in the prescription department with the prescription container label on it?
Yes, if the patient’s name is obliterated and redispensed to another patient within one year or less from the filling date on the prescription container label
(T/F) The charge paid for the original prescription cannot be reversed for drugs returned to stock.
- False, they must be reversed
- Failing to reverse the charge can result in substantial fines for the pharmacy.
What if the transaction has been completed, the patient goes home with the dispensed prescription, and then comes back and wants to return the drug?
- You cannot accept the dispensed drug for return and place it back into stock, because you don’t know what has happened to the dispensed drug in the interim.
- Even if it is in a sealed container.
What if a patient doesn’t accept the delivery of a dispensed prescription to their home?
You can accept the dispensed drug for return and place it back into stock, because the delivery person knows the conditions under which it has been kept.
Can you accept a returned drug if dispensed prescriptions are mailed to a patient and they are returned because of a wrong address?
- You cannot accept the dispensed drugs for return and place them back into stock, because you don’t know what has happened once they have left your control.
- They would have to be destroyed.
What if the wrong drug or the wrong strength of the correct drug is dispensed to a patient pursuant to a valid prescription?
- You should correct the situation by dispensing the correct drug or the correct strength to the patient.
- The wrong drug or wrong strength can be returned to stock if the error is noticed while the patient is still in the pharmacy.
- This scenario includes controlled substances.
- The wrong drug or wrong strength must be destroyed if the transaction has already been completed as previously described.
(T/F) According to federal and Nebraska guidelines, drugs dispensed for administration to inpatients within a hospital (i.e., not pursuant to a prescription) can be returned to stock and redispensed to other inpatients within the hospital.
- But not allowed for ophthalmic products, otic products, topical products, products for bedside use, etc.
Federal and Nebraska laws do not address the return of ____________________ that have been purchased.
nonlegend drugs (OTC for personal use)
A nonlegend drug cannot be returned if it is_____________________________________.
outdated or if the tamper-evident or tamper-resistant packaging is not intact
Federal and Nebraska laws do not address the disposal or destruction of___________________________.
(T/F) The Environmental Protection Agency (EPA) regulates the practice of non-legend drug disposal.
False, though they may in the future
The American Pharmacists Association (APhA) suggests what method for the disposal of drugs?
Crushed or diluted in water, mixed with kitty litter or another solid medium (e.g., coffee grounds or sawdust), sealed in a plastic bag, and then placed in the trash.
The federal Resource Conservation and Recovery Act (RCRA) of 1976 requires:
The development of a successful plan for appropriate storage, logging, and reporting of pharmaceutical waste as well as training of appropriate individuals
The FDA currently recommends what disposal method for drugs?
That certain medications be flushed because of their abuse potential
According to federal law, a registrant must contact the nearest _______________________ for instructions on the disposal of controlled substances that are part of its inventory.
DEA Diversion Field Office
Prior authorization by the DEA Diversion Field Office is not required if a controlled substances is going to be destroyed by______________________, ____________________ or __________________________.
an authorized member of a state law enforcement authority or regulatory agency (e.g., a state pharmacy inspector) or by a reverse distributor
What is a reverse distributor?
A company registered with the DEA who specializes in the handling of outdated or unneeded drug products, including controlled substances.
The _______________________ is responsible for verifying that the reverse distributor is registered with the DEA.
Controlled substances must not be sent to the DEA unless the registrant has received__________________________________.
prior approval from the DEA
A DEA Form 41, which may be obtained from a _______________________ or the __________________.
- pharmacy inspector
- DEA's website
_____________________, is used to document the destruction of controlled substances that are part of a registrant's inventory.
A DEA Form 41
What is required to be documented on a DEA Form 41?
- The name of drug or preparation; number of containers; contents (number of grams; tablets, ounces or other units per container); and controlled substance content (each unit).
- Registrant's DEA number; telephone number; signature of the applicant or authorized agent; date the controlled substances were surrendered/destroyed; signature of the person receiving/destroying the controlled substances; and signature of the person witnessing the receipt/destruction.
(T/F) DEA form 41: The original is sent to the pharmacy registrant, a copy is retained by the pharmacy inspector or the reverse distributor, and a copy is sent to the DEA.
False, the original is sent to the DEA, a copy is retained by the pharmacy inspector or the reverse distributor, and a copy is retained by the registrant
Effective 10/9/14, federal law allowed authorized __________________________________________________________to collect controlled substances from ultimate users (i.e., patients) by voluntarily administering mail-back programs and maintaining collection receptacles.
manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics with an on-site pharmacy, and retail pharmacies
An authorized entity can become an authorized collector by modifying______________________.
Their DEA registration
Authorized collectors may maintain collection receptacles located __________________________.
inside their registered location
An authorized collector must have ______________________________ in order to operate a mail-back program.
an on-site method of destruction (e.g., incineration)
A registrant cannot dispose of controlled substance inventory in______________________________________.
a collection receptacle, mail-back package, or take-back event
According to federal law, ______________________ and ___________________________are allowed to voluntarily maintain collection receptacles at a long-term care facility (LTCF).
authorized hospitals/clinics and retail pharmacies
The contents of a sealed inner liner from a collection receptacle, which is waiting to be transferred or destroyed, may be stored at the LTCF for up to __________________________ in a securely locked, substantially constructed cabinet or a securely locked room with controlled access.
three business days
The contents of a sealed inner liner from a collection receptacle, which is waiting to be transferred or destroyed, may be stored at the LTCF for up to three business days in a___________________________________ or _____________________________.
securely locked, substantially constructed cabinet or a securely locked room with controlled access
In Nebraska, Complete records of the destruction of controlled substances shall be maintained by the registrant for __________________ after the date of destruction.
In Nebraska, Schedule ___________________ drugs may be destroyed by a pharmacy inspector, by a reverse distributor, or by the administration.
II, III, IV, or V
In Nebraska, Schedule II, III, IV, or V drugs may be destroyed by a____________________, ______________________ or_____________________.
pharmacy inspector, by a reverse distributor, or by the administration
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