ASHP Chapter 3 Drug Enforcement Agency Requirements

Question 1

DEA registration Requirements::
Which form for pharmacy MUST register with the DEA?

Answer 1

DEA form 224
- to register a new Pharmacy,
DEA form MUST be completed online or a paper copy may be requested via writing

Question 2

Where the certificate DEA form 224 must be maintained ?

Answer 2

The certificate must maintain at the Register location, and kept on hand for the inspection purpose

Question 3

If a person owns and operate more than one pharmacy, what requirement from DEA ?

Answer 3

If a person owns and operates more than one pharmacy, EACH place , a business must be registered

Question 4

DEA registration requirements for renewal registration:
How many years does DEA form must renew?

Answer 4

Renewal of registration must be renew every three years ?

Question 5

What form does pharmacy ‘s DEA requires for renewal of registration?
And when can pharmacy renewal be done before, is expired ?

Answer 5

The renew a registration using DEA form, 224a, renewal, application for DEA registration.
-renewal can be done online, no more than 60 days before prior to current expiration date .
-if the registration has not renew in 50 days before expiration date, a DEA form 224a is sent to the address registered.

Question 6

If the register has not renewed 50 days before the expiration day, what will happen?

Answer 6

The DEAform 224a is sent to the address registered

Question 7

If DEA form 224a it’s not received within 30 days what happened?

Answer 7

If DEA form 224a it’s not received within 30 days, the registrant must contact the local DE a registration specialist

Question 8

DEA registration requirements.
What is the requirement -renew y registration -Retail chain?

Answer 8

Corporations that owns or operates to a chain of pharmacies will submit DEA 224b, Retail Pharmacy Chain Affidavit for Chain Renewal
-The original affidavit and a list of the corporations registrations must be mailed to the Registration Chain Renewal division of the DEA

Question 9

DEA Registration Requirement:
-what steps must be done for modifications?

Answer 9

-Any modifications (I.e. Address change) must be approved by the DEA.

-If the modification is approved, a new certificate of registration will be issued along with the new DEA form 222s,if registered

-The registration should maintain a new registration and the old registration station until expiration

Question 10

DEA Registration Requirements:
-What must be done for transfer of business?

Answer 10

-14 days prior to the transfer from one pharmacy registrant to another, in person or by certified mail, must submit to the following information to the DEA Special Agent in Charge of the area.

Question 11

Transfer of business requirements fill out information?

Answer 11

A. 1-the name.
2-address.
3-registration number.
4-registrant transferors (- - authorization business activity after registration discontinue the business)
B- 1-the name
2-address
3-registration number
4-registrant-transferee (authorized, business activity of the person acquiring the business)

C- whether the business activities will be continued after location registered by the person, discontinuing business, or moved to another location, is the latter, the address of the new location should be listed); and

D- the date on which the transfer of control substances will occurred

Question 12

DEA registration requirements -Transfer a business (continue):
-on the day of transfers:

Answer 12

-On the day of the transfers, and inventory of all controlled substances must be taken. This will act as the final inventory for the registrant going out of business, and the initial inventory of the registrant acquiring the control substances.

Question 13

DEA registration requirements:
-what should be done for scheduled II CS when transferring of business for control substances ?

Answer 13

-For Schedule II CS, the receiving registrant must complete a DEA Form 222 transferring the drugs.
-For Schedule III-V, the transferred must be done in writing, and show the drug names, dosage, form, strength, quantity, and the date transferred.
-The document must also include the names, addresses, and DEA registration numbers of all parties involved in the transfer.

Question 14

DEA Registration Requirements:
-Reasons for :
-denial ?
-suspensions ? - -revocation of registration ?

Answer 14

1-falsifying the application.
2-convicted of a felony related to a control substances.
3-has had a state, license, revoked, suspend it, or denied
4-committed an act that would rendered the registration inconsistent.
5-has been excluded from participation in a program (medical, Medicare)
6-any act that may threatened public health and safety

Question 15

DEA Forms:
-which form for all pharmacy that dispense controlled substances,?
-how many years must be renewed for registration?

Answer 15

-DEA form 224.
-Must be with you every 3 years

Question 16

What is DEA form for pharmacy renewal 224a?

Answer 16

DEA form 224a is for pharmacy DEA renewal registration form.

Question 17

What is the DEA form 224b?

Answer 17

DEA form 224b is DEA renewal registration form for chained pharmacies

Question 18

What is DEA form 222 ?

Answer 18

DEA form 222 is the order form used to order Schedule II controlled substances

Question 19

What is DEA form 41?

Answer 19

DEA form 41 - it is form used by pharmacies to destroy control substances

Question 20

What is DEA form 106?

Answer 20

DEA form 106-it is for used to report that on lost of controlled substances: include

1-name and address of firm(pharmacy)
2-DEA registration number
3-date of theft or lost (or when discovered if not known)
4-name and telephone number of local police department, if notify
5-type of that(that is night break in or on robbery)
6 List of identifying marks, symbols, or price quote.(if any used by the pharmacy on the label of the container and
7-a listing of control substances missing, including the string, dosage, form, and size of container(in milliliter if liquid form) or corresponding national drug code numbers

Question 21

What is DEA form 107?

Answer 21

DEA form 107-it is for report that or lost chemicals

— all records must kept readily retrievable and separate from all other records for two years

Question 22

What is CSOS?

Answer 22

CSOS is the DEA controlled substances ordering system.
-electronic ordering of control substances via CSOS is optional and registrant are still permit to submit paper DEA form 222 if they like

Question 23

How long the DEA 222 form must be kept?

Answer 23

-All records must be kept for 2 years in a readily reachable area, separate from all the records

Question 24

What does CSOS allow electronic transmission schedule?

Answer 24

CSOS allows electronic transmission of schedule II controlled substances between manufacturers, distributors, Pharmacies, and all the DEA entities
-CSOS can include C I-V

Question 25

What are the different between paper DEA 222 and CSOS ?

Answer 25

Paper DEA form 222.
-Only C I-II allowed.
-only 10 lines per form
-Only one location frills
-Reports each month.
-Handwritten

CSOS:
-can include C I-V
-any numbers of lines?
-Multiple fill locations.
-Report every two business days.
-Identifies drug by its national drug court (NDC)

Question 26

CSOS allow what with signature?

Answer 26

CSOS allows:
-ordering is permit via a digital signature
1-the registry will obtain a digital signature
2-along with any individual granted power of attorney by the register it
CSOS digital certificate will be active until the DEA registration expires

Question 27

What causes CSOS to Unaccepted or Defective Order?

Answer 27

Unaccepted or Defected Order:
1-not all filled completed.
2-order is not signed using a digital signature.
3-digital certificate has expired.
4-the purchasers public key will not validate the certificate.
5-validation of the order shows that the order is invalid in someway

-If an order cannot be filled supplier must provide the purchaser with an explanation 

Question 28

DEA controlled substance ordering system (CSOS) :
when supplier cancel or voiding of an electronic order :

Answer 28

Cancellation or avoiding of an electronic order
- all or part of the order can be divided by supplier
-The supplier must notify the purchaser, and indicate which items were not shipped or voided.
-If the entire order is voided, the supplier must make a copy of the order, and indicate void and return to the purchaser.
-This must be kept by the purchase it for 2 years

Question 29

How many schedules divided into of controlled substance .?

Answer 29

Controlled substances are divided into schedules, I -V
-Schedule one medication have a high potential for abuse and currently have not accepted medical use in the United States.
Schedule IImedication also have a high potential for abuse, and may result in dependency.
Schedule III medication have a moderate to low potential for abuse.
Schedule VI medication have low potential for abuse.
Schedule V medication also have low potential abuse

Question 30

Which controlled substances are at a highest risk for diversion?

Answer 30

-opioids
-Athletic performance- in enhancing drugs
-non-opioid psychotropic drug

Question 31

DEA controlled substance:

—Physical inventories:
1-initial inventory

Answer 31

1-initial inventory
- The registrant must take an actual physical count of all controlled substances upon being granted DEA registration.
-if there are no stocks on hand, a zero inventory should be indicated.
-Definition of inventory does not have to be turned in, but does have to be kept on record

Question 32

Physical inventory:
1-what does initial inventory requirements?

Answer 32

1-the date of the inventory
2-whether the inventory was taking at the beginning of clothes of business,
3-the name of each controlled substance inventoried
4-the finished form of each of these substances (e.g. 10 milligram tablet),
5-The number of dosage units of eight finished form in the commercial container (e.g. 100 tablets bottle)
6-The number of commercial containers of H finished form (e.g. four 100 tablets bottles),
7-account of the substance-if the system is listed in scheduled II call Ma an exact count or measure of the contents or if the system is listed in schedule III ,IV, or V,
An estimated count or measure of the contents, unless the container holds more than 1000 tablets or capsules, in which case, and exact count of the contents is required

Question 33

Physical inventory
-Initial inventory requirements continue

Answer 33

— initial inventory required( continues)
-The DEA recommend the names, address, and DEA registration number of the registrant, and signature of the person conducting the inventory be included on the initial inventory

Question 34

Physical inventory :
how many years require the inventory for control substance?

Answer 34

Biennial inventory
-conducted every two years and requires the same information as the initial inventory
-Not required to submit a copy to the DEA

Question 35

Physical inventories
-Newly schedule CS

Answer 35

An inventory of control substances , not previous listed or rescheduled, must be taking us effective day, or when medication is rescheduled

Question 36

Robbery or theft
what is need to be done when you notify CS drug is missing

Answer 36

1-notified the DA and loco police
-directions to must notify, in writing, the DA Diversion Field Office within one business day of the discovery.
-The statement must be signed by the registrant a copy must be kept
2-complete DEA form 106
-used to document the actual circumstances of the event and the quantity involve

Question 37

Robbery or theft

Answer 37

1-notify the DEA and local office
2-complete DEA form 106
3-if investigation find out theft

Question 38

What are information DEA 106 should include:

Answer 38

1-name and address of the fairness ( pharmacy)
2-DEA registration number
3-date of theft or loss(or when discovered if not known)
4-name and telephone number of local police department (if notified)
5- types of theft (e.g. night reckon, armed robbery)
6-list of identifying marks, symbols, I’ll price code, if any use by the pharmacy on the label all containers
7-a list of controlled substance missing,, including the strength, dosage, form, inside of container (in milliliter in liquid form) or corresponding national drug numbers

Question 39

Robbery or theft
-If the investigation finds no theft

Answer 39

-DEA form 106 does not to be filed
-registrant must notify the DEA in writing regarding the findings to results initial report and why no DEA form 106 was filed

Question 40

Procedures for sales of OTCs
what is COMBAT METHAMPHETAMINE EPIDEMIC ACT ? And what year??

Answer 40

Combat methamphetamine epidemic act of 2005
-it is the product containing-
1-pseudoephedrine ,
2-ephedrine,or
3-Phenylpropanolamine

These products kept behind the counter pharmacy are in lock in cabinet.

Question 41

What are requirement of buying these products containing 
One the ingredients ?

Answer 41

Logbook must be kept on all approaches and maintained for at least two years
1-must include the purchasers name and address
2-signature of the purchaser.
3-product sold.
4-quantities showed.
5-date and time

Question 42

What kind of training that employees must have to certify selling this products under
Combat meta-amphetamine epidemic act of 2005?

Answer 42

Training:
1-Employee must be trained on dispensing and understand the requirement of the law
2-training must be certified and sent to the DEA for record

Question 43

Combat Methamphetamine  epidemic act of 2005 limits quantity?

Answer 43

Quantity limit
1-quantity sold to an individual in a day to 3.6 g of the chemical-based without regard to the number of transaction.

2-non-liquids:
- product packaging is limited to blister packs containing no more than two dosage units per blister.
-where blister packs are not technically visible, the product must be packaged in a unit does package or pouch
3-individuals:
- purchases in a 30 days. I limited to 9 g of which no more than seven point grams may u a contact carrier or the US post service