BNDD EXAM WITH VERIFIED
SOLUTION
Who is required to have a registration? - ANSWER All persons and businesses in
Missouri who want to conduct any activities with controlled substances, including
purchasing, stocking, ordering, prescribing and administering, must first obtain a state
controlled substances registration.
Order:
A person obtains their *professional license* first and then the *state controlled
substance registration* is obtained second.
The *federal DEA registration* is obtained last.
What about federal DEA registrations? - ANSWER After a professional license and state
controlled drug registration are issued, then a federal DEA registration must be
obtained. The federal registration may be applied for at www.deadiversion.usdoj.gov
How do I apply and what is the process? - ANSWER A person may apply for a new state
controlled substances registration at any time. Once a professional license has been
issued, the pharmacy may apply for and obtain a Missouri Controlled Substances
Registration and then a federal DEA registration. You may apply online at the BNDD
website https://health.mo.gov/safety/bndd or obtain an application from the Bureau's
website and mail it in.
State registrations issued in Missouri only - ANSWER May only be issued at a Missouri
practice location where controlled substance activities take place and patient care
occurs
A registration is required at each place where controlled substances are *stocked*,
*distributed* or *dispensed* in Missouri
The bureau does not require out of state pharmacies or distributors to obtain a Missouri
registration in order to ship into Missouri, as long as they are only shipping and they do
not have a storage facility in Missouri.
Notifying the regulatory authorities if you change practice locations. - ANSWER Notify
state and federal within 30 days of your new location or your controlled substance
registration automatically terminates.
What can cause a registration to close or automatically terminate? - ANSWER The
following circumstances can cause a registration to terminate:
,1. A registration closes on the date of expiration printed on the certificate. There are no
extensions or waivers issued under the law. A new registration must be obtained to
conduct controlled drug activities.
2. When a pharmacy goes out of businesses, ceases legal existence or does not have
their
professional license or pharmacy permit.
3. If and when a business changes ownership. *Registrations cannot be transferred to
another person*. The new owners must have their own registration. When there is a
change of ownership, *the new owner may operate under the registration of the seller
during a 30-day grace period*. By the 31st day, the new owners must have obtained
their own.
5. If and when the person discontinues business or changes practice location. There is a
30-day grace period to notify the BNDD within 30 days of the effective date of the
change.
6. A registration may be terminated at the request of the registrant.
How do I make changes to my existing registration? - ANSWER Changes to an existing
registration may be completed at the BNDD website or by mailing or faxing a written
request to the Bureau. The Bureau will change names, addresses, and adjust drug
schedules for no additional fee.
Will I automatically get a renewal notice? - ANSWER Although not required by law, as a
courtesy the BNDD sends an email to each registrant, 60 days before the expiration date
of their current registration. The BNDD emails the reminder to the address the Bureau
has on file from the registrant's application. Please insure email addresses are up to
date.
Registration certificates should be kept readily retrievable. - ANSWER Your federal DEA
controlled substance registration must be maintained at your registered practice
location and must be readily retrievable upon inspection.
BNDD Registration Certificates - ANSWER The BNDD will no longer be mailing printed
certificates. Registrants may verify and print their registration data from the website at
https://health.mo.gov/safety/bndd.
LTCFs Have Their Own Registrations - ANSWER Retail pharmacies do not need to obtain
registrations at LTCFs to transfer drug stock to LTCFs. In Missouri LTCFs have their own
drug registrations. LTCFs are separately registered and are responsible for controlled
,substances that enter their facilities. There is much more detailed information that
follows in the section addressing LTCFs and pharmacy relationships.
How much can a pharmacy transfer? - ANSWER A pharmacy can transfer up to 5% of
their stock. Once meeting the 5% threshold, they must obtain a license and registration
as a distributor.
State and federal controlled substance laws require all controlled substance records to
be maintained for a period of - ANSWER Two years
These records must be maintained at the registered practice location and must be
readily retrievable and open to inspection and copying by the BNDD.
What are required on the receipt records of controlled substances received- - ANSWER
*4D, Q, DAN(X2), NI*
Registrants must maintain the following information for all controlled substances
received:
1. Date of receipt;
2. Drug name
3. Dosage form
4. Drug strength
5. Quantity received
6. Name, address and DEA number of the supplier
7. Name, address and DEA number of the recipient (No DEA# for LTCFs)
8. Name or initials of employees verifying receipt of the drugs
The receipt records for Schedule III—V drugs should be in a separate file from the DEA
Form 222 Official Order Forms used for Schedule II drugs.
These receipt records may be kept in a *handwritten or typed log* or *may be
maintained electronically.* The third copies of all DEA Form 222 Order Forms must be
signed and dated to verify receipt of the Schedule II drugs.
If a practitioner chooses to use a supplier's invoice, billing record, or packing document
as a record of receipt, it that practitioner's responsibility to review the document to
make sure that the required information is documented on the receipt record.
Do LTCF's have DEA numbers? - ANSWER No
When is the initial inventory
is required for the Initial inventory of controlled substances - ANSWER On the very first
, date that you receive and engage in the stocking and receipt of controlled substances,
The following information must be documented on an inventory:
(*5D, Q*)
1. Date
2. Documentation of whether the inventory was taken at Opening of business (OOB) or
Closing of business (COB) or time of inventory if practice location is open 24 hours a
day.
3. Drug name
4. Drug strength
5. Dosage form
6. Quantity of dosage units on hand
The initial inventory of Schedule II drugs must be maintained on a separate form and
document than the initial inventory of Schedule III—V drugs.
Do not perform an inventory that combines Schedule II drug counts with drugs in
Schedule III—V and do not include any non-controlled drugs on these inventory
documents.
What is required on the dispensing record for controlled substances. - ANSWER
Pharmacies are required to maintain records of all controlled substances dispensed.
(*4D, Q, NA, NI*)
1. Date of dispensing
2. Patient name/owner if animal
3. Patient address/owner if animal
4. Drug name
5. Drug strength
6. Dosage form
7. Quantity
8. Name or initials of employee performing the dispensing
Can control substance inventories be electronic? - ANSWER *All inventories must be on
paper and not electronic.*
After an initial inventory for controlled substances has been completed on the day you
SOLUTION
Who is required to have a registration? - ANSWER All persons and businesses in
Missouri who want to conduct any activities with controlled substances, including
purchasing, stocking, ordering, prescribing and administering, must first obtain a state
controlled substances registration.
Order:
A person obtains their *professional license* first and then the *state controlled
substance registration* is obtained second.
The *federal DEA registration* is obtained last.
What about federal DEA registrations? - ANSWER After a professional license and state
controlled drug registration are issued, then a federal DEA registration must be
obtained. The federal registration may be applied for at www.deadiversion.usdoj.gov
How do I apply and what is the process? - ANSWER A person may apply for a new state
controlled substances registration at any time. Once a professional license has been
issued, the pharmacy may apply for and obtain a Missouri Controlled Substances
Registration and then a federal DEA registration. You may apply online at the BNDD
website https://health.mo.gov/safety/bndd or obtain an application from the Bureau's
website and mail it in.
State registrations issued in Missouri only - ANSWER May only be issued at a Missouri
practice location where controlled substance activities take place and patient care
occurs
A registration is required at each place where controlled substances are *stocked*,
*distributed* or *dispensed* in Missouri
The bureau does not require out of state pharmacies or distributors to obtain a Missouri
registration in order to ship into Missouri, as long as they are only shipping and they do
not have a storage facility in Missouri.
Notifying the regulatory authorities if you change practice locations. - ANSWER Notify
state and federal within 30 days of your new location or your controlled substance
registration automatically terminates.
What can cause a registration to close or automatically terminate? - ANSWER The
following circumstances can cause a registration to terminate:
,1. A registration closes on the date of expiration printed on the certificate. There are no
extensions or waivers issued under the law. A new registration must be obtained to
conduct controlled drug activities.
2. When a pharmacy goes out of businesses, ceases legal existence or does not have
their
professional license or pharmacy permit.
3. If and when a business changes ownership. *Registrations cannot be transferred to
another person*. The new owners must have their own registration. When there is a
change of ownership, *the new owner may operate under the registration of the seller
during a 30-day grace period*. By the 31st day, the new owners must have obtained
their own.
5. If and when the person discontinues business or changes practice location. There is a
30-day grace period to notify the BNDD within 30 days of the effective date of the
change.
6. A registration may be terminated at the request of the registrant.
How do I make changes to my existing registration? - ANSWER Changes to an existing
registration may be completed at the BNDD website or by mailing or faxing a written
request to the Bureau. The Bureau will change names, addresses, and adjust drug
schedules for no additional fee.
Will I automatically get a renewal notice? - ANSWER Although not required by law, as a
courtesy the BNDD sends an email to each registrant, 60 days before the expiration date
of their current registration. The BNDD emails the reminder to the address the Bureau
has on file from the registrant's application. Please insure email addresses are up to
date.
Registration certificates should be kept readily retrievable. - ANSWER Your federal DEA
controlled substance registration must be maintained at your registered practice
location and must be readily retrievable upon inspection.
BNDD Registration Certificates - ANSWER The BNDD will no longer be mailing printed
certificates. Registrants may verify and print their registration data from the website at
https://health.mo.gov/safety/bndd.
LTCFs Have Their Own Registrations - ANSWER Retail pharmacies do not need to obtain
registrations at LTCFs to transfer drug stock to LTCFs. In Missouri LTCFs have their own
drug registrations. LTCFs are separately registered and are responsible for controlled
,substances that enter their facilities. There is much more detailed information that
follows in the section addressing LTCFs and pharmacy relationships.
How much can a pharmacy transfer? - ANSWER A pharmacy can transfer up to 5% of
their stock. Once meeting the 5% threshold, they must obtain a license and registration
as a distributor.
State and federal controlled substance laws require all controlled substance records to
be maintained for a period of - ANSWER Two years
These records must be maintained at the registered practice location and must be
readily retrievable and open to inspection and copying by the BNDD.
What are required on the receipt records of controlled substances received- - ANSWER
*4D, Q, DAN(X2), NI*
Registrants must maintain the following information for all controlled substances
received:
1. Date of receipt;
2. Drug name
3. Dosage form
4. Drug strength
5. Quantity received
6. Name, address and DEA number of the supplier
7. Name, address and DEA number of the recipient (No DEA# for LTCFs)
8. Name or initials of employees verifying receipt of the drugs
The receipt records for Schedule III—V drugs should be in a separate file from the DEA
Form 222 Official Order Forms used for Schedule II drugs.
These receipt records may be kept in a *handwritten or typed log* or *may be
maintained electronically.* The third copies of all DEA Form 222 Order Forms must be
signed and dated to verify receipt of the Schedule II drugs.
If a practitioner chooses to use a supplier's invoice, billing record, or packing document
as a record of receipt, it that practitioner's responsibility to review the document to
make sure that the required information is documented on the receipt record.
Do LTCF's have DEA numbers? - ANSWER No
When is the initial inventory
is required for the Initial inventory of controlled substances - ANSWER On the very first
, date that you receive and engage in the stocking and receipt of controlled substances,
The following information must be documented on an inventory:
(*5D, Q*)
1. Date
2. Documentation of whether the inventory was taken at Opening of business (OOB) or
Closing of business (COB) or time of inventory if practice location is open 24 hours a
day.
3. Drug name
4. Drug strength
5. Dosage form
6. Quantity of dosage units on hand
The initial inventory of Schedule II drugs must be maintained on a separate form and
document than the initial inventory of Schedule III—V drugs.
Do not perform an inventory that combines Schedule II drug counts with drugs in
Schedule III—V and do not include any non-controlled drugs on these inventory
documents.
What is required on the dispensing record for controlled substances. - ANSWER
Pharmacies are required to maintain records of all controlled substances dispensed.
(*4D, Q, NA, NI*)
1. Date of dispensing
2. Patient name/owner if animal
3. Patient address/owner if animal
4. Drug name
5. Drug strength
6. Dosage form
7. Quantity
8. Name or initials of employee performing the dispensing
Can control substance inventories be electronic? - ANSWER *All inventories must be on
paper and not electronic.*
After an initial inventory for controlled substances has been completed on the day you
