






















Study with the several resources on Docsity
Earn points by helping other students or get them with a premium plan
Prepare for your exams
Study with the several resources on Docsity
Earn points to download
Earn points by helping other students or get them with a premium plan
Community
Ask the community for help and clear up your study doubts
Discover the best universities in your country according to Docsity users
Free resources
Download our free guides on studying techniques, anxiety management strategies, and thesis advice from Docsity tutors
A comprehensive overview of the regulations and practices surrounding controlled substances in the united states. It covers topics such as the scheduling of drugs by the hhs, emergency dispensing, partial fillings, inventory requirements, reporting lost or stolen substances, registration and renewal processes, destruction of controlled substances, prescription expiration and dispensing limits, labeling requirements, and the regulations around pseudoephedrine sales. The document also touches on the kefauver-harris amendment, good manufacturing practices, the drug facts panel, and various device classifications by the fda. This information would be highly relevant for healthcare professionals, particularly pharmacists, who need to ensure compliance with the complex legal framework governing controlled substances.
Typology: Exams
1 / 30
This page cannot be seen from the preview
Don't miss anything!
Who decides which schedule a drug is in? ✔✔The HHS (Secretary of Human Health Services) gives a scientific evaluation to the attorney general and then pretty much decides which schedule the drug should be in. The attorney general can make a drug schedule 1 on the grounds that it can cause "imminent hazard to the general public" without consulting the secretary of HHS
How long does a prescriber have to give a hard copy to the pharmacist, after administration of an emergency CII prescription? ✔✔The prescriber has 72 hours to mail or hand in the prescription otherwise the pharmacy must contact the DEA and DCU! Failure to contact the DEA would make the pharmacy unauthorized to take emergency CII prescriptions
What words must be on the hard copy after administration of an emergency CII prescription? ✔✔"Authorization for Emergency Dispensing"
How many drugs can be given in an emergency CII prescription? ✔✔Only enough to cover 72 hours
Are partial fillings for CIII - CV prescriptions allowed? ✔✔Yes
How many partial fillings are allowed on a CIII prescription? ✔✔More than 5 partial fillings are allowed. However, only 5 refills are allowed on a CIII prescription.
What is the three drawer method for filing prescriptions? ✔✔1. CII drugs
What are the two two drawer methods for filing prescriptions? ✔✔1. CIIs
How long do pharmacy inventory records need to be kept? ✔✔2 years with the CII records kept separately from the CIII-CV records
Can a pharmacy do its inventory at a different date than the regular biennial inventory date? ✔✔Yes, they can do the date they originally counted the inventory (when the pharmacy opened) OR another significant date for the pharmacy.
There is a 6 month rule where they can do the inventory within 6 months of the picked date.
Either way if they are not doing the biennial date, they must notify the DEA and DCU.
What happens to copy 1, 2, and 3 of the DEA 222 Form? ✔✔The purchaser keeps copy 3 and then sends copy 1 and 2 to the supplier. The supplier keeps copy 1 and sends copy 2 to the DEA. In short:
copy 3 = purchaser
copy 2 = DEA
copy 1 = supplier
Can you white out or erase a mistake on a DEA 222 form? ✔✔no! write VOID on the spot on all three copies and file it with your new copy.
Can you throw away a DEA 222 Form with a mistake on it? ✔✔NO! You should keep it with your new copy.
Who has to sign the DEA 222 form? ✔✔Only the registrant OR someone with Power of Attorney (not just the pharmacist or pharmacy manager)
What does the pharmacy need to record on copy 3 of the DEA 222 Form? ✔✔Record the number of containers and the date received
So the supplier received an order for hydromorphone and they do not have enough so they send some but not all to the purchaser. How long does the supplier have to fill the rest of that order? ✔✔The supplier has 60 days to fill the order
but the purchaser can cancel part or all of the order and then the SUPPLIER (and not the purchaser) just has to write "cancelled" and drawing a line on copy 1 and 2.
Are electronically transmitted CII - CV prescriptions allowed? ✔✔So they are allowed but you still need the written prescription before dispensing..... so in the law it says they are allowed but they pretty much are not...
What does the Ryan Haight Online Pharmacy Consumer Protection Act deal with? ✔✔Trying to reduce illegal online sale of controlled substances. It requires that pharmacies that sell controlled substances online get the prescriptions directly from the prescriber and have modifications to their DEA registrations
What is a DEA 106 Form for? ✔✔Lost or stolen controlled substances
If controlled substances are lost who is responsible for reporting the loss- the purchaser or the supplier? ✔✔After the shipment has been signed for or taken custody by the purchaser then the purchaser needs to file the DEA 106 Form. Before that, the supplier needs to report that loss. (these things include a retail pharmacy or central fill pharmacy)- whoever has custody of the controlled substances needs to report the loss.
In NJ you also need to submit a DDC 52 Form to the DCU for lost and stolen controlled substances.
Does the DCU need to be notified of any controlled substances loss or theft? ✔✔Yes (most things that the DEA needs to be notified the DCU needs to be notified too)
How often does a pharmacy have to register with the Attorney General? ✔✔TRIENNIALLY (every 3 years!) this is the only one that is every 3 years from what I know- a chain can do it all in one and same with a hospital pharmacy but if a hospital pharmacy has a outpatient pharmacy those two have to register separately
How often does a manufacturer need to register with the Attorney General? ✔✔Every year
How often does a distributor need to register with the Attorney General? ✔✔Every year
What is the maximum amount of controlled substances allowed to be transferred to another pharmacy without the pharmacy being required to register as a distributor? ✔✔less than 5%
What does it mean if the DEA number has a hyphen. Ex. AC 0123455-86? ✔✔It means it is being prescribed by a physician, intern, or resident under a hospital's DEA number
Where can grandma get rid of her extra oxycodones? ✔✔Authorized manufacturers, distributors, retail pharmacies, hospitals (which have on-site pharmacies), and narcotic treatment programs who have modified their DEA registrations to include disposal programs. This was called the "Final Rule" or Secure and Responsible Drug Disposal Act of 2010
There are also mail-back programs, collection receptacles and collection events (which pharmacies can participate in)
What is a pharmacy that becomes a "collector" mean? and is there a special instruction within New Jersey to do this? ✔✔A collector is allowed to do on-site destruction of controlled substances as well as be allowed to take people's unused medications.
In New Jersey, there is an additional step- within 5 days of becoming a "collector" they must inform the DCU (Drug Control Unit)
What is the difference about damage/spilled controlled substances that are recoverable vs non- recoverable (like spilled down the sink) ✔✔The recoverable damaged controlled substances must be destroyed and a DEA 41 Form must be filled out.
A non-recoverable damaged controlled substances are recorded in the controlled substances record and do not need a DEA 41 Form.
How long does a pharmacy have to notify the DEA of a theft or significant loss of a controlled substance? ✔✔one business day!
How does a prescriber get multiple CII drugs and CIII - CV drugs through a pharmacy so they can distribute it to their patients? ✔✔For CII drugs they need a DEA 222 Form and for CIII-CV drugs they need an invoice.
However, this can not be done for methadone for detoxification purposes (but pain purposes are okay)
Expiration for CII prescription?
Expiration for CIII - CV prescription? ✔✔CII prescription expiration = 30 days after issued
CIII - CV prescription expiration = 6 months after issued
-name of transferring pharmacist
-date of transfer
What must the transferee pharmacist have to do? ✔✔-write "Transfer" on the prescription
-date of issue of new prescription
-original number of refills
-number of refills remaining
-dates and locations of all previous refills
-original date of dispensing
-pharmacy name, address, DEA number, and prescription number of transferring pharmacy
-name of transferring pharmacy
-pharmacy name, address, DEA number and prescription number from which the prescription information was originally filled
Can a pharmacy intern take down a prescription? ✔✔Yes, but not a tech
How many refills are allowed on a CIII - CV prescription? ✔✔5 max refills within the 6 months before the prescription expires
How long do you need to keep controlled substances refill information? ✔✔5 years
Can a practitioner authorized additional refills on a CIII-CV oral refill authorization?
If so, what are the requirements? ✔✔Yes they need:
-the total number of refills can not exceed 5 refills on one prescription or extend beyond 6 months for that prescription
-that pharmacist initials, dates, writes the quantity authorized and number of additional refills on the reverse side of the original prescription
-THE QUANTITY OF EACH REFILL CAN NOT EXCEED (BUT CAN BE LESS) THAN THE QUANTITY AUTHORIZED FOR THE INITIAL FILLING
Can a pharmacist refuse the inspection or withdraw consent at any time during an inspection if the inspector only has a Notice of Inspection? ✔✔Yes, however they can not refuse a Search Warrant or Administrative Inspection Warrant
Is faxing a CII prescription allowed? ✔✔So yes but you need the original hard copy of the prescription before dispensing.
Unless it is for:
Long term detoxification = more than 30 but less than 180 days
Maintenance = more than 21 days
Can Suboxone and Subutex be dispensed at a retail pharmacy? ✔✔Yes
Is it law to lock up controlled substances? ✔✔Most pharmacies do it and it is recommended but it is not a law because it can be just dispersed throughout the pharmacy so theft would require some time to locate it all.
When can a long term care facility have controlled substances on hand?
And what are the terms and conditions? ✔✔In emergency kits!
-as long as the source (pharmacy or physician) has a DEA registration
-limited access to emergency kits and limited quantity in the kits
-maintain complete records of the controlled substances in the kit
-the controlled substances are administered by authorized personnel only
What is the 2 very specific requirements New Jersey has for the labeling for commercial packages of controlled substances? ✔✔1. The schedule symbol must be in the upper right hand corner
2.The symbol must be in a font that is two times the size of the largest print on the rest of the bottle or half the height of the label
What are the four letters a DEA number can start with for a Type A (practitioner)?
Mid-Level Practitioner?
Wholesaler?
Buprenorphine guy? ✔✔Type A: A, B, F, or G
Mid-level: M
Wholesaler: P or R
Buprenorphine guy: X
List of things that have to be on every label: ✔✔-the pharmacy name and address
-the pharmacy telephone number
-generic or brand name along with the other
-quantity
-strength
-prescription number
-"use by date"
A transmitting pharmacy wants to send over a prescription to a central fill pharmacy electronically. What does the transmitting pharmacy have to do? ✔✔write on the face of the prescription "central fill" then record it
Can a physician write a prescription for an animal? ✔✔No. A veterinarian can not prescribe anything for a human and a physician can not prescribe anything for an animal
Would the animal's name be on the prescription? ✔✔No. The species of animal, the owner's name and address would be on the prescription.
Sentences for burglary or robbery?
burglary or robbery with a weapon?
death resulted? ✔✔burglary or robbery = 20 years and/or $25,
burglary or robbery with weapon = 25 years and/or $35,
death resulted: life in prison and/or $50,
How much pseudoephedrine can someone purchase in one day? ✔✔3.6 grams
How much pseudoephedrine can someone purchase in 30 days? ✔✔9 grams
How much pseudoephedrine can someone purchase over the mail in 30 days? ✔✔7.5 grams
Can pseudoephedrine be out on the sales floor? ✔✔No it must be behind the counter
What is recorded in the logbook for pseudoephedrine sales? ✔✔name, address, date and time of purchase. Can be either electronic or written.
How much pseudoephedrine is allowed to be sold without having to be recorded in a logbook? ✔✔60mg
How long do you have to keep an entry in the pseudoephedrine logbook? ✔✔2 years
Is there an age requirement for purchasing pseudoephedrine? ✔✔Nope, not in the federal or NJ state law