Federal Cds Laws

Front 1

Who has scheduling authority?

Back 1

Attorney General

Front 2

When can the Attorney General schedule a drug w/o consult with the HHS Secretary?

Back 2

Only if the drug must be placed into CI status to avoid an imminent hazard to public safety

Front 3

When is an emergency (telephone or fax) CII order OK?

Back 3

1. No other therapeutic option

2. CII is absolutely needed immediately

3. It's not possible for doc to give a written script

Front 4

What are the FEDERAL requirements for emergency C-II dispensing?

Back 4

1. Immediately reduce to writing

2. Only dispense enough drug to get thru the emergency period

3. Make an effort to ascertain the script is legit

4. "Authorization for emergency dispensing" must be written on the cover script

5. Cover script must be forwarded to pharmacy within 7 days OR postmarked within 7 days.

6. RPh needs to attach the script to the oral script

Front 5

What are the two main rules for partially filling a C-II to a regular dude?

Back 5

1. You have 72 hours to get the dude the balance

2. You have to note the quantity dispensed on the face of the script

Front 6

What are the unique situations when it's OK to dispense partial C-IIs?

Back 6

1. LTCF

2. Hospice patient

Front 7

How for LTCF or hospice patients, how long can you partial C-IIs out?

Back 7

60 days (date of issue?)

Front 8

If you're gonna partial a C-II what do you gotta record?

Back 8

1. Who did it?

2. How much was dispensed?

3. How much remains?

4 When was this done?

Front 9

Is it OK to partial a C3-5?

Back 9

Yes. So long as you don't dispense past 6 months.

Front 10

What are the 3 filing methods for CDS?

Back 10

1. 2s, 3-5s, legend
2. 2-5, legend
3. 2s, everything else

Front 11

Where does the C stamp need to be?

Back 11

lower right hand corner

Front 12

How often should CDS inventory be taken?

Back 12

q2 years

Front 13

When can C3-5s be estimated?

Back 13

<1000 ct bottles

Front 14

How long must inventory records be kept?

Back 14

2 years

Front 15

You can keep CDS inventory records centrally as long as you notify the DEA in _______, with _______ days advance notice.

Back 15

triplicate; 14 days

Front 16

Upon written request from DEA the records must be provided within ________

Back 16

2 business days

Front 17

How to order 222 forms?

Back 17

222a

Front 18

Who gets what copy of the 222?

Back 18

Copy 1 supplier
Copy 2 DEA
Copy 3 Registrant

Front 19

If a 222 cannot be filled completely, the supplier has _____ days to get the purchaser the balance.

Back 19

60

Front 20

What 3 special CIIs need their own form?

Back 20

Carfentanil
Etorphine
Diprenorphine

Front 21

Can a purchaser cancel part of a CII order?

Back 21

Yes! Notify the supplier in writing

Front 22

Can a supplier void part of a CII order?

Back 22

Yes! Notify the purchaser in writing.

Front 23

In transit losses. Who submits what form?

Back 23

It depends who has "custody" of the CII's.

If the supplier notices the loss of a CDS before delivered to the purchaser, the supplier must fill out a DEA 106.

Vise vira, if the purchaser signs for the order the purchaser must fill out a 106.

Front 24

I'm a pharmacist at Rite Aid and put out a 222 for McKesson last week. I still haven't received my order and I think it's been lost. What do I have to do?

Back 24

1. Execute another 222

2. Execute 3 copies of a statement that states: date of original form, serial number of the original form, statement of it's proposed loss

3. Attach a copy of this statement to every copy of the new 222

Front 25

I'm at rite aid and had my used (or unused) 222s stolen from my control box. What do I do?

Back 25

1. contact local special agent in charge

2.State the serial number of each form lost - if i dont know, then list the approximate date of receipt

Front 26

How often must pharmacies register with the attorney general for DEA/ CDS activity? What about mfgrs or distributors?

Back 26

q3 years; q1year

Front 27

A pharmacist can mfgr (w/o registering as a mfgr) an aqueous or solid CDS as long as.....

Back 27

the total CDS concentration is <20% of the complete soln

Front 28

A pharmacy can distribute drugs to other pharmacies or doctors (w/o registering as a distributor) as long as.....

Back 28

total sales from distribution are <5% in a year

Front 29

Form used to register pharmacies w/ DEA? Initally? Subsequent?

Back 29

224; 224a

Front 30

Chestertown pharmacy changed its name to C-town drugs. What must be done WRT DEA registration?

Back 30

1. notify DEA in writing for any address or name change

Front 31

The owner/ registrant of Chestertown pahrmacy dies. What happens to the DEA registration?

Back 31

DEA must be notified and the registration is terminated. Same goes for corporations going out of business.

Front 32

Can DEA registrations be transferred?

Back 32

Only after the DEAs approval pending a written request.

Front 33

Talk about 1/yr DEA authorization to destroy CDS.

Back 33

1. Submit a DEA form 41

2. Submit a written request to nearest DEA office at least 2 weeks before proposed date proposing a method of destruction and at least 2 witnesses

3. Witnesses can be MD, RN, RPh, Midlevel, or Law Enforcement

Front 34

When can you get a blanket authorization to destroy CDS?

Back 34

Registrants that are regularly required to dispose of CDS (e.g., MedTurn). MedTurn must keep records of each disposal and file periodic reports with local Special Agent in Charge of DEA.

Front 35

If you notice CDS theft or loss, when must you notify the DEA?

Back 35

1 business day of the discovery

NOT necessarily with a 106. You just need to notify them in writing (usually fax). You can do your own investigation and if you find that nothing was really lost or stolen then you dont need to submit a 106.... but you should write back to the dea and let them know why a 106 wasnt submitted.

Front 36

Can a non-DEA registered LTCF have an emergency kit? If yes, under what conditions?

Back 36

Yes;

1. Obtain the kit/drugs from a DEA registrant

2. Proper security safegaurds

3. The supplying registrant AND LTCF maintain accurate records

4. COnditions for use are clearly defined

Front 37

When are C-II Rx labeling requirements waived?

Back 37

1. Institutional patients

2. NMT 7 ds

3. Appropraite safeguards

4. Not in posession of ultimate end user

Front 38

When are C-III-V Rx labeling requirements waived?

Back 38

1. Institutional patients

2. NMT 34 ds or 100 DUs, whichever is less

3. Appropraite safeguards

4. Not in posession of ultimate end user

Front 39

What needs to be in the label if a CDS was filled at a CF pharmacy?

Back 39

1. the retail pharmacy name and addy

2. A unique identifier of the CF pharmacy (DEA number for example)

Front 40

What must the tranmitting pharmacy (retail pharmacy) do to an Rx if it wants it filled centrally?

Back 40

1. Write central fill on face of rx

2. Record:

A. name + addy + dea of CFP

B. RPh @ transmitting pharmacy

C. Date of transmission

3. Keep a receipt:

A. Date of receipt

B. How was it delivered

C. Who accepted delivery

Front 41

What must the CF pharmacy do if it wants to fill centrally for a tranmitting pharmacy?

Back 41

1. Keep a copy of the Rx

2. Name, addy, DEA of retail pharmacy

3. Date of recipt of Rx

4. RPh that filled the rx centrally

5. Date rx was filled centrally

6. How and when was the rx delivered back to retailer?

Front 42

My pharmacy is going out of business. I'm not transferring any business activity. What do I have to do?

Back 42

1. Return registration
2. Return 222s
3. Fill out a DEA 41

Front 43

My pharmacy is going out of business. I'm transferring business activity. What do I have to do?

Back 43

1. Contact DEA 14 days advance with a proposal

2. Transfer must be to another registrant

Front 44

How long are CDS records kept under federal law?

Back 44

2 years

Front 45

Can you employ someone who has been convicted of a felony related to CDS?

Back 45

no