chapter 3 (UMPJE) - controls

Who is in charge of adding, deleting, or rescheduling controls?

US Attorney General

A pharmacy may compound narcotics pursuant to a RX, however the DEA limits the compounding of "aqueous or oleaginous solutions or solid dosage forms" to no more than ___% concentration

20%

Concentration limits of CODEINE (2)

• CV limit 200 mg/100 mL

• CIII limit 1.8 g/100 mL and 90 mg/dosage unit

Concentration limit of MORPHINE (1)

• CIII limit 50 mg/100 mL

Concentration limit of OPIUM (2)

• CV limit 100 mg/100 mL

• CIII limit 500 mg/100 mL and 25 mg/dosage unit

Concentration limit of DIHYDROCODEINE (2)

• CV limit 100 mg/100 mL

• CIII limit 1.8 g/100 mL and 90 mg/dosage unit

DEA registration form (224a) must be renewed every ____ years

3

• 224 is the registration form

• 224a is the renewal form

HOW TO VERIFY A DEA REGISTRATION # (3 steps)

1. Add 1st, 3rd, and 5th digits

2. Add 2nd, 4th, 6th digits and multiple sum by 2.

3. Add the sum of steps 1 and 2, and the last digit of the sum should correspond to the last digit of the DEA number

What letter should a DEA registration # start with for a MD vs. PA? (3)

• Everyone besides mid levels start with A, B, or F

• Mid levels like PA, NP, CRNA start with M

• Department of defense contractors will start with G

DEA FORM 224

New application for DEA registration (includes retail pharmacies, hospitals, practitioners, etc)

DEA FORM 224A

• Renewal form for DEA registration, that is renewed every 3 years

DEA FORM 225

• New DEA registration application for manufacturers, distributors, researchers, labs, importers, exporters

• Renewed yearly

DEA FORM 363

• New application for narcotic treatment facilities

DEA FORM 222

• Ordering CII's

• Single copy form that contains 20 order lines per form

• KEEP FOR 2 YRS

How long should 222 forms be kept for?

2 years and must be kept separate from other pharmacy records

A CII's supplier has to provide a partial qty on the 222. The remaining qty must be sent within ___ days or the order becomes void!

60 days

What happens if you lose your 222 form?

• You must prepare another 222

• Statement containing the serial number and date the form was lost

Can a pharmacy fax a 222 to a supplier?

Yes but only for them to prepare the order, but for the supplier to ship the product they must have the OG 222 form!

What is CSOS?

• Controlled Substances Ordering System

• Orders CII's online with no line item limit

How are CIII-CV's ordered?

Through a normal ordering process from a wholesaler or manufacturer

What must the invoice contain when ordering CIII-CV? (7)

• Name of controls

• Dosage form

• Strength

• Number of units per container

• Quantity recieved (containers)

• Date

• Name, address, DEA # of registrant from where the controls were recieved

Book says to know this

Does a pharmacy have to register with the DEA as a distributor when transferring controls?

NO as long as the total quantity of controls distributed during a calendar year does not exceed 5%!

What is the 5% rule?

• A pharmacy may transfer controls to another pharmacy/MD office w/out DEA distributor registration if the total amount transferred during the calendar year is ≤5% of the pharmacy’s total annual controlled substance dispensing volume.

• >5% = pharmacy must register as a DEA distributor

DEA FORM 41

• On site destruction of controls in a pharmacy (Rx destroyer at work)

• Where the pharmacy destroys them thereselves

What is the preferred method of destroying controls?

• Authorized reverse distributor

• Controls are transferred from the pharmacy to the reverse distributor to destroy

What is an authorized collector?

• Allows a pharmacy to collect controls from the patient after they were dispensed to assist in disposal (secure drop box for ultimate users or can be at a LTCF)

• Can either transfer to a reverse distributor, destroy onsite with DEA form 41, or contact a DEA special agent

What is the mail back program for destroying controls?

• You mail them to a authorized collectors registered address

• Must notify DEA within 3 business days of receipt if damaged, unexpected, opened, etc.

delete

delete

T/F: You can store controls dispensed throughout the non-controlled stock to deter theft

True

T/F: You can store controls on a single unsecured shelf

False - it must be in a secure locked cabinet if stored all together

If a theft or significant loss of controls occurs, you must notify the DEA in writing within ___ business day of discover and notify the police

1

DEA FORM 106

• Theft & loss reporting form

• Must be submitted to the DEA within 45 days of discovery, but must notify DEA within 1 business day!!!

DEA form 106 must be submitted to the DEA within ___ days

45

DEA FORM 107

• Theft & loss of listed chemicals (pseudoephedrine)

• Must be submitted within 15 calendar days and notify local DEA office

What classes of controls must the federal transfer warning be included on?

• CII-CIV (not on CV)

• Caution federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed

Inventory of controls must be done every ___ years

2

Inventory counts of controls ** (2)

• EXACT count for all CII's

• ESTIMATE is allowed for CIII-CV unless the container holds ≥1,000 tablets or capsules

Records of controls must be maintained for ____ years and kept separately or be readily retrievable from other records

2

How should written & verbal controlled RX be stored? (3 vs. 2 file)

T/F: Written controlled prescriptions must be signed manually by the practitioner and dated

True

What must a written controlled RX contain? (12)

• Name of patient

• Address of patient

• Drug name

• Drug strength

• Drug dosage form

• Qty

• Directions

• Number of refills (except CII)

• Name of prescriber

• Address of prescriber

• DEA # of prescriber

• If written for a CII to be filled at a later date, the earliest date on which a pharmacy may fill the RX

Can you accept a verbal RX for a CII?

NAWRRR - unless its an emergency

Can you accept a verbal RX for a CIII?

YES - you can for CIII-CV, just not for CII

Can you accept a faxed CII?

NO - unless:

1. Narcotic for home infusion or IV pain therapy

2. LTCF

3. Narcotic for hospice care patient

What are the 3 exceptions for faxing a CII?

1. Narcotic for home infusion or IV pain therapy

2. LTCF

3. Narcotic for hospice care patient

What forms of a CII prescription can be accepted?

Written or electronic

What is EPCS?

• Electronic prescription for controlled substances

• Allows for electronic CIIs

Prescriber vs pharmacy requirements

Telemedicine and buprenorphine

• DEA allows buprenorphine prescribing by audio-only or audio-video encounters

• No initial in person eval required through 12/31/2026

Only up to ___ months of buprenorphine may be prescribed before an inperson evaluation is required

6

T/F: Original prescriptions for controls may generally not be transferred for initial filling?

True

Can you transfer CII's?

• There is no refills so generally there is no transfers

• A one-time transfer of a CII is allowed between pharmacies that share a real-time online database system

What cannot be changed on a CII prescription? (4)

• Patient name

• Drug name

• Name of prescribing physician

• Date issued

What is the quantity limit for CII's?

• There is no specific quantity limit for CII on a single prescription under federal law!

Must receive the prescription within ___ days after authorizing an emergency CII prescription

7

PARTIAL FILLS OF CII: unable to fill - 72 hour rule

• If a pharmD cant fill the entire qty on a CII, a partial qty may be provided as long as the remaining qty is provided within 72 hours

• If the remaining qty cannot be provided, the pharmD must notify the prescriber

PARTIAL FILLS OF CII: patient or prescriber request - 30 day rule

• Remaining portions must be filled within 30 days from issue date

• Oral emergency CII still limited to 72 hrs

• Request can be made when prescription is issued or after consultation with a pharmacist

PARTIAL FILL OF CII: long term care and terminally ill - 60 day rule

• Federal law allows for partial fills as many times as needed

• Must be completed within 60 days!

3 SITUATIONS WITH PARTIAL FILLS

After ___ months, a CIII-CIV prescription is no longer valid, even if refills remain

6 months

How many refills are allowed for CIII-CIV prescriptions?

5 times in 6 month period

How many refills are allowed for CV prescriptions?

Up to 1 year of refills (same as non controls)

Can you transfer a CIII-CV?

Refills can be transferred???

T/F: CV's can actually be sold without a prescription

True - Robitussin AC (contains codeine)

OTC sale of CV total quantity limits

4 oz of Robitussin AC every 48 hours

What is the only indication that methadone can be dispensed for?

PAIN

A physician who is NOT a part of a narcotic TX program may administer (not prescribe) methadone to an addicted individual for no more than a ___ day period until the pt can be enrolled in a narcotic TX program

3 day

What is the only drug that can be dispensed by a pharmacy to treat OUD?

BUPRENORPHINE

What are the limits for psuedoephedrine?

• 3.6 g/day

• No more than 9 g of base per 30 days

Combat Methamphetamine Act of 2005

• Passed to further control the sale of OTC products containing precursor chemicals used in the illicit manufacturing of methamphetamine

• Listed chemical products: ephedrine, pseudoephedrine, and phenylpropanolamine

What are the most common exceptions for not being a mandatory PDMP check (4)?

• Patients with specific diseases (cancer or SCD)

• Hospice or palliative care

• Technological failure

• Emergency situations

Can you post date multiple CII prescrptions?

No, this means puting date acting like it will be filled in a month

• Instead the prescriber must indicate earliest fill date on other prescriptions written

• Total 90 day supply max between all prescriptions written

Does federal law make you spell out the quantity?

NO!!! Just has to be clear

What element must be required on controlled RX for doggies?

Name and address of owner

- Dog breed, weight, etc is NOT required

Can a prescriber write "QS" for quantity on a CII?

No - the quantity must be specified before filling

T/F: There are no federal expiration date for CII's

TRUE !! but pharmDs use their judgement, if I got a script for oxy after a surgery and decided to fill it 6 months later, the pharmD can see when is written and not fill it i belive

A prescription for a CIV is written with refill as needed. How many times can this be filled?

A. Zero

B. 5 times

C. 11 times

D. As many times as the patient wants for 6 months

A. Zero

When transferring a CIII-CV between 2 pharmacies that dont share an electronic database, what must the transferring pharmd write on the invalidated RX?

A. Transferred

B. Void

C. Cancelled

D. No longer valid

Regarding the emergency period for a CII, how many days supply can the PharmD dispense?

A. 3 days max

B. 7 days max

C. A quantity sufficient to treat the patient only during the emergency period

D. No more than 30 dosage units

C. A quantity sufficient to treat the patient only during the emergency period

If a patient is out of refills for their insulin, and the MD is unreachable on a holiday. How much can the pharmD dispense?

A. Exactly 72 hours

B. Up to 30 day supply or the smallest standard unit

C. Nothing, dispensing without a refill is always a violation of federal law

D. Only a 24 hour supply until the doctors office opens

A pharmD dispenses an emergency refill of a non-controlled med. How soon must they notify the prescriber?

A. Immediately by telephone

B. Within 72 hours of dispensing

C. Within 7 days

D. At the time of the next regular refill

T/F: A prescriber manual signature is required on an emergency fill

FALSE - since its an emergency

What is the limit on emergency refills per patient?

once per year

UMPJE disaster protocols allow pharmD to dispense up to a ____ day supply of life essential non controlled meds

30

WHO CAN SIGN A 222?

• The registrant (individual MD, partner, or officer for coporations) OR a POA.

• The POA does not need to be sent to the DEA but must be maintained in the pharmacy.

- Can be pharmD, tech, buyer, or other authorized employer

• POA must be signed by the person granting the power, the person receiving the power, and 2 witnesses!

WHO CAN SIGN/RENEW A 224?

• Electronically signed

• An applicant can authorize another individual to sign by doing a POA

• No witnesses needed

T/F: If you forget to renew the 224A on the 3rd year, you can have a 1 calendar month grace period

True

WHO CAN SIGN CSOS?

• CSOS is a digital certificate that is unique to an individual and specific DEA registration

• A CSOS signing certificate can only be issued by the registrant or a POA to order controls

- Can be pharmD, tech, buyer, or other authorized employer

• This POA MUST be signed by 2 witnesses and be sent to DEA so they can get their certificate!

A pharmacy uses a reverse distributor to destroy a container of expired CII powder. Who is responsible for completing the DEA 41.

A. The pharmacy

B. The reverse distributor

C. The manufacturer

D. The local police

B. The reverse distributor

Since they are the ones that are going to be destroying the drugs, not the pharmacy

T/F: you can keep 222 forms at a central location

False