VA General Regulatory Processes Flashcards
What is a Scheduled Listed Chemical Product?
A product that contains ephedrine, pseudoephedrine or phenylpropanolamine.
What is a federal schedule VI drug?
There’s no such thing! VA classifies prescription drugs that are not in another schedule as Schedule VI, but there is no federal schedule VI.
If a pharmacy goes out of business, what does it need to surrender to the DEA?
Its DEA registration certificate and and DEA form 222s it has
If a pharmacy moves to a new location, does it need to get a new DEA registration?
No, the registrant can apply for a modification of registration
If a pharmacy goes out of business, can it destroy all of its records?
No, records need to be retained for as long as they would be kept if the pharmacy were open. Controlled substances inventories, prescriptions, and other records need to be kept for 2 years.
If one pharmacy is being sold to another, what information must be submitted to the DEA?
- name, address, registration number and authorized business activity of the seller and of the buyer
- whether the business activities will be continued at the location or moved
- the new address, if the business is being moved
- date the controlled substances will be transferred
When the controlled substances are transferred to the new pharmacy it is being sold to, do you need to take an inventory? Do you need to send a copy of the inventory to the DEA? Do you need to do anything else to transfer the controlled substances?
- YES
- No, but the person transferring the business and the person acquiring the business must both keep a copy
- Schedule II drugs are transferred using form (DEA Form 222). Schedules III-V must be documented, including the names, addresses and DEA registration numbers of the parties involved in the transfer.
What are some reasons the DEA may deny, suspend or revoke a registration?
- there is false information in the application
- the applicant has a controlled substance felony conviction
- the applicant’s state license is suspended or revoked
- the applicant has committed an act which would render the DEA registration inconsistent with the public interest
- the applicant has been excluded from participating in medicaid or medicare
What factors does the DEA consider in determining “public interest”?
- recommendations of the state licensing board or professional disciplinary authority
- the applicants experience in dispensing or conducting research with controlled substances
- the applicant’s controlled substances conviction record
- compliance with controlled substances laws
- any other conduct which may threaten the public health and safety
A hotel gift shop wants to be able to sell a Scheduled Listed Chemical Product (SLCP) such as pseudoephedrine. Are they allowed to?
The store needs to self-certify with the DEA as a regulated seller.
Does a pharmacy need to self-certify with the DEA to sell SLCPs?
NO. If the pharmacy is already registered to handle CS it doesn’t need a separate DEA chemical registration to sell SLCPs.
If SLCPs are lost or stolen, how long does the pharmacy or regulated seller have to report it?
They must report the loss or theft to the DEA within 15 days after discovering it.
What paperwork is required to transfer schedules III-V controlled substances?
Written documentation showing:
- drug name and dosage form
- strength
- quantity
- date transferred
- names and addresses of the parties involved
- DEA registration numbers of the parties involved
How long do the transferring records need to be kept?
2 years
How can a pharmacy dispose of controlled substances?
By transferring them to a DEA registered reverse distributor. Requirements for paperwork are the same as for any other transfer- DEA 222 form for Schedule II drugs, and written documentation for Schedule III-V drugs.
A pharmacy is considering hiring someone who has a criminal record. Is this allowed?
Some people are barred from employment in positions that allow access to controlled substances. This includes people who:
- Have been convicted of a felony relating to a controlled substances
- Have had an application for DEA registration denied, revoked, or surrendered for cause
Is it possible to get a wavier to employ someone who would otherwise be barred from employment? What information should go into the waiver request?
Yes, a waiver request may be sent to the DEA. The waiver has to be approved before the person can have access to CS.
Info needed:
1. information about the person’s past controlled substance violations
2. Current status of the person’s state license
3. Extent of proposed access to controlled substances
4. what safeguards will be in place to prevent diversion
5. Information about the registrant (the employer)
What is “Corresponding Responsibility”?
The practitioner who writes a prescription may only write it for a legitimate medical need, within a valid patient-prescriber relationship. The pharmacist has a “corresponding responsibility” - a responsibility to exercise professional judgement to determine whether the prescription is valid, and to only fill valid prescriptions.
I think a prescription is invalid and I decline it. It turns out the prescription actually was valid. Can I be prosecuted?
No. If the prescription is questionable, the pharmacist isn’t required to dispense it.
IF a pharmacist overlooks a questionable prescription for a controlled substance and dispenses it, can he be prosecuted?
Yes! If there was a reason to believe it was not issued for a legitimate medical purpose, this is a felony offense.
Can Schedule II CS be prescribed electronically?
Yes, as long as the pharmacy is using software that complies with DEA regulations. The software must be audited and certified and the same rules apply to electronic prescriptions that apply to paper. For example, if a notation would be required on a paper prescription the same information is required in electronic records.
Can you print out electronic prescriptions, delete them and store your records as paper?
No. When a prescription is received electronically, the prescription and all required annotations must be stored electronically.
The DEA must be notified of any significant theft or loss of controlled substances. If you report the theft the local police, does that fulfill the requirement?
No. You always have to notify the DEA within one business day.
What form do you use to report the theft or loss?
DEA Form 106
What information should be on a DEA Form 106?
- name and address of the pharmacy
- DEA registration number
- Date of theft or loss
- name and telephone number of local police department
- type of theft
- list of identifying marks, symbols, or price codes used by the pharmacy containers
- a listing of CS missing, including the strength, dosage form and size of the container or NDC numbers
After reporting a loss, the pharmacist realizes that there actually was no loss. Does the pharmacist need to notify the DEA?
Yes, in writing.
If a controlled substance is lost in transit, is the purchaser or the supplier responsible for notifying the DEA?
If the purchaser has signed for the shipment already they are responsible. If the purchaser refuses the shipment and returns it to the supplier the supplier is responsible.
