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Pharm Law Iowa > ORDERING CONTROLLED SUBSTANCES > Flashcards

ORDERING CONTROLLED SUBSTANCES Flashcards

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1
Q

On September 30, 2019, DEA issued a final rule entitled New Single-Sheet Format for U.S. Official Order Form for Schedule I and II Controlled Substances (DEA Form 222), what is the “sunset date” for using up the old triplicate forms?

A

October 30, 2021

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2
Q

Which controlled substances are ordered with an official paper order form, DEA Form 222, or the electronic equivalent?

A

Only schedule I and II controlled substances

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3
Q

What form is required for each distribution or transfer of a schedule I or schedule II controlled substance unless
exempted?

A

A DEA Form 222

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4
Q

When a controlled substance has been moved by DEA from schedule I or schedule II to another schedule at the federal level, in many states it may remain a schedule I or
schedule II controlled substance, why?

A

pending any legislative or administrative action that
may result from the federal action. Also States may require transactions that involve substances they classify as schedule I or schedule II to be made via DEA Form 222 or the electronic equivalent.

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5
Q

DEA Forms 222 are issued in mailing envelopes containing a predetermined number of forms based on

A

the business activity of the registrant, each form consisting of one single-sheet.

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6
Q

What if you need more DEA Forms 222 then they send you?

A

A limit, which is based on the business activity of the registrant, will be imposed on the number of DEA Forms 222 that will be furnished upon a requisition for
order forms unless additional forms are specifically requested and a reasonable need for such additional forms is shown.

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7
Q

Who is entitled to obtain a DEA Form 222?

A

Any person with an active registration that is authorized to order schedule I and II controlled substances

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8
Q

What must provided when submitting a DEA Form 222 request?

A

Each requisition must show the name, address, and registration number of the registrant and the number of DEA Forms 222 desired.

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9
Q

Where do you request the DEA Form 222 from?

A

requisition the forms through a DEA secured network connection or by contacting a local DEA Diversion Field Office or the Registration Section of the Administration through the customer service center

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10
Q

What is on a DEA Forms 222?

A

DEA Forms 222 have an order form number and are issued with the name, address, and registration number of the registrant, the authorized activity, and schedules of the registrant.

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11
Q

Can the information on a DEA Forms 222 be altered by the registrant?

A

No, the registrant must report any errors to the local DEA Diversion Field Office or the Registration Section of the Administration to modify the registration.

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12
Q

What can be used to fill in a DEA Form 222?

A

A purchaser must prepare and execute a DEA Form 222 by use of a typewriter, computer printer, pen, or indelible pencil.

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13
Q

When filling out a DEA Form 222 how many items may be entered on each numbered line?

A

Only one item may be

entered on each numbered line.

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14
Q

What is considered an item when filling out a DEA Form 222?

A

An item must consist of one or more commercial or

bulk containers of the same finished or bulk form and quantity of the same substance.

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15
Q

Where must the number of lines completed be noted on that form?

A

on that form at the bottom of the form, in

the space provided.

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16
Q

The purchaser should record the name and
address from whom the controlled substances are being ordered must be entered on the form 21 CFR 1305.12(c). If the purchaser does not have this information where should they get it?

A

then the supplier should ensure it is on the form.

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17
Q

Who gets the original of the DEA Form 222 and who gets the copy?

A

The purchaser must make a copy of the original

DEA Form 222 for its records and then submit the original to the supplier.

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18
Q

The copy of the DEA Form 222 retained by the purchaser may be in what format?

A

The copy retained by the purchaser may be in paper or electronic form.

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19
Q

Each DEA Form 222 must be signed and dated by whom?

A

a person authorized to sign a registration application or a person granted power of attorney

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20
Q

When the items are received, the purchaser must document what on the purchaser’s copy?

A

the actual number of commercial or bulk containers received and the date received.

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21
Q

Who must retain a copy of each executed DEA Form 222 and all copies of unaccepted or defective forms with each statement attached.

A

The purchaser

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22
Q

who must retain the original DEA Form 222 for the

supplier’s files

A

The supplier

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23
Q

Any supplier who is not required to report acquisition/disposition transactions to the Automation of Reports and Consolidated Orders System (ARCOS) under 1304.33(c) (such as a practitioner) must do what?

A

make and submit a copy of the original DEA Form 222 to DEA, either by mail to the Registration Section, or by email to DEA.Orderforms@usdoj.gov.

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24
Q

The copy of the DEA Form 222 must be forwarded when?

A

at the close of the month during which the order is filled. If an order is filled by partial shipments, the copy must be forwarded at the close of the month during which the final shipment is made or the 60-day validity period expires.

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25
Q

DEA Forms 222 must be maintained _________ from all other records of the registrant.

A

separately

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26
Q

DEA Forms 222 are required to be kept available for inspection for how long?

A

a period of two years.

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27
Q

If a purchaser has several registered locations, the purchaser must retain a copy of the executed DEA Form 222 and any attached statements or other related documents (not including unexecuted DEA Forms
222, which may be kept elsewhere under 21 CFR 1305.12(e)), where?

A

at the registered location printed on the DEA Form 222.

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28
Q

Electronic copies of DEA Forms 222 do not need to be stored on a different server or electronic system from a registrant’s other records. The requirement to store DEA
Forms 222 separately from all other records may be met, for electronic copies, by?

A

storing them in such a way that they can be readily retrieved separately from all other records.

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29
Q

Electronic copies of DEA Forms 222 may be stored on a

system at a location different from the registered location, provided such copies are what?

A

readily retrievable at the registered location

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30
Q

Purchasers must be able, during an inspection or upon other DEA requests, to readily retrieve what?

A

their electronic copies of Forms 222, with any related statements or other documents, and without any other records.

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31
Q

Under 21 CFR 1305.15(a)(1), an order must not be filled if

A

the Form 222 is not complete, legible, or properly prepared, executed, or endorsed, or if the Form 222
shows any alteration, erasure, or change of any description.

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32
Q

If a DEA Form 222 cannot be filled for any reason, the supplier must return the original DEA Form 222 to the purchaser with what?

A

a statement explaining the reason the order could

not be filled (e.g., illegible or altered).

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33
Q

A supplier may refuse to accept an order for what reason?

A

They can refuse for any reason.

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34
Q

If a supplier refuses to accept an order what do they have to supply?

A

a statement that the order is not accepted is sufficient.

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35
Q

For electronic orders, if the order cannot be filled, the supplier must?

A

notify the purchaser and provide a statement as to the reason; if the order is refused, a statement that the order
is not accepted is sufficient

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36
Q

When a purchaser receives an unaccepted order, the original DEA Form 222 and the statement must be retained where?

A

in the files of the purchaser

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37
Q

When a purchaser receives an unaccepted electronic order from a supplier, the purchaser must?

A

electronically link the statement of non-acceptance to the original order, and retain the original order and the statement

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38
Q

How must a defective DEA Form 222 may not be handle?

A

A defective DEA Form 222 may not be corrected; it must be replaced by a new DEA Form 222 for the order to be filled.

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39
Q

Any registrant (pharmacy) may authorize one or more individuals, whether or not they are located at the registered location, to obtain and execute DEA Forms 222 by?

A

granting a power of attorney to each such individual

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40
Q

Pursuant to 21 CFR 1305.05(d), the power of attorney must be signed by:

A
  1. The registrant, if an individual; a partner of the registrant, if a partnership; or an officer of the registrant, if a corporation, corporate division, association, trust or
    other entity;
  2. The person to whom the power of attorney is being granted; and
  3. Two witnesses.
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41
Q

May power of attorney executed under this section be signed electronically?

A

A power of attorney executed under this section may be signed electronically, by any or all of the persons required to sign

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42
Q

When can the power of attorney be revoked and by whom?

A

The power of attorney may be revoked at any time by the person who signed the most recent application for DEA registration or reregistration and two witnesses.

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43
Q

When is it necessary to grant a new power of attorney?

A

Only if the renewal application is signed by a different person is it necessary to grant a new power of attorney when the pharmacy completes a renewal registration.

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44
Q

The power of attorney should be filed with what form?

A

The power of attorney should be filed with executed

DEA Forms 222 if applicable, and must be available for inspection.

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45
Q

Do you submit the power of attorney to DEA?

A

The power of attorney is not submitted to DEA.

46
Q

A purchaser may cancel part or all of an order on a DEA Form 222 by:

A

notifying the supplier in writing of the cancellation. 21 CFR 1305.19(a).

47
Q

When the supplier cancels part of an order on a DEA Form 222 they must:

A

indicate the cancellation on the original DEA Form 222 sent by the purchaser by drawing a line through the canceled items and printing “canceled” in the space provided for the number of items shipped.

48
Q

If a purchaser ascertains that an unfilled DEA Form 222 has been lost what do they need to do?

A

the purchaser must execute another and attach a statement containing the order form number and date of the lost form, and stating that the goods covered by the first DEA Form 222 were not received through loss of that DEA Form 222.
A copy of the second form and a copy of the statement must be retained with a copy of the DEA Form 222 first executed. A copy of the statement must be attached to a copy of the second DEA Form 222 sent to the supplier.

49
Q

If the first DEA Form 222 is subsequently received by the supplier to whom it was directed, the supplier must do what?

A

mark upon the face “Not accepted” and return the original DEA Form 222 to the purchaser, who must attach it to the statement.

50
Q

A pharmacy, upon discovery of the loss or theft of used or unused order forms must do what?

A

must immediately report the loss or theft to the local DEA Diversion Field Office (Appendix K)
and provide the serial numbers of each lost or stolen order form.

51
Q

If any DEA Forms 222 are lost or stolen, and the purchaser is unable to provide the order form numbers of DEA Forms 222, the purchaser must do what?

A

report, in lieu of numbers of the forms, the date or approximate date of issuance.

52
Q

If an unused order form reported stolen or lost is later recovered or found, the pharmacy must do what?

A

immediately notify the local DEA Diversion Field Office

53
Q

If the registration of any purchaser terminates (because the purchaser dies, ceases legal existence, discontinues business or professional practice, or changes the name or address as shown on the purchaser’s registration) or is suspended or revoked under 21 CFR 1301.36 for all schedule I and II controlled substances for which the purchaser is registered, what must the purchaser do?

A

the purchaser must return all unused DEA Forms 222 to the Registration
Section.

54
Q

Registrants may continue to use existing stocks of the triplicate DEA Form 222 until October 30, 2021. In any case, as soon as a registrant’s supply of triplicate DEA Forms 222 is exhausted, the registrant must?

A

the registrant must use the new single-sheet DEA Form 222.

55
Q

DEA no longer issues triplicate forms. Triplicate DEA Forms 222 will not be accepted
after

A

October 30, 2021.

56
Q

A purchaser must prepare and execute a triplicate DEA Form 222 simultaneously by means of what?

A

interleaved carbon sheets that are part of the triplicate DEA Form 222.

57
Q

Triplicate DEA Forms 222 must be prepared by use of

A

a typewriter, pen, or indelible pencil.

58
Q

How many items may be may be entered on each numbered line of a triplicate DEA Form 222?

A

Only one item

59
Q

An item must consist of

A

one or more commercial or bulk containers of the same finished or bulk form and quantity of the same substance.

60
Q

The number of lines completed must be

noted where on the triplicate DEA Form 222?

A

The number of lines completed must be

noted on that form at the bottom of the form, in the space provided.

61
Q

Each triplicate DEA Form 222 must be signed and dated by whom?

A

a person authorized to sign a registration application or a person granted power of attorney.

62
Q

When the items are received, the purchaser must

document on the purchaser’s copy (copy three) what?

A

the actual number of commercial or bulk containers received and the date received.

63
Q

The executed triplicate DEA Form 222 must be maintained ___________ from the pharmacy’s other business records.

A

separately

64
Q

If a purchaser has several registered locations, the purchaser must retain Copy 3 of the executed triplicate DEA Form 222 and what?

A

any attached statements or other related documents at the registered location printed on the triplicate DEA Form 222.

65
Q

21 CFR 1305.20(e) requires that, for orders using the triplicate DEA Form 222, an order must not be filled if

A

the order is not complete, legible, or properly prepared, executed, or endorsed, or if the order shows any alteration, erasure, or change of any description.

66
Q

If an order cannot be filled, the supplier must return what copies of the triplicate DEA Form 222 as well as a statement explaining what?

A

1 and 2 of the triplicate DEA Form 222 to the purchaser with a statement explaining the reason the order could not be filled (e.g., illegible or altered).

67
Q

A supplier may refuse to accept an order for any reason. If a supplier refuses to accept an order, what must be sent?

A

a statement that the order is not accepted is sufficient.

68
Q

When a purchaser receives an unaccepted order, Copies _________ of the triplicate DEA Form 222 and the statement must be attached to ______ and retained in the files of the __________.

A

1 and 2 of the triplicate DEA Form 222, Copy 3, purchaser

69
Q

A defective triplicate DEA Form 222 can it be corrected?

A

It may not be corrected; it must be replaced by a new triplicate DEA Form 222 for the order to be filled.

70
Q

The __________ must retain Copy 3 of each executed triplicate DEA Form 222 and?

A

purchaser, all copies of unaccepted or defective forms with each statement attached.

71
Q

A purchaser may cancel an order (or part of an order) on a triplicate DEA Form 222 by

A

notifying the supplier in writing

72
Q

The supplier must indicate the cancellation on __________of the triplicate DEA Form 222 by drawing a line through the canceled item(s) and printing “canceled” where?

A

Copies 1 and 2, in the space provided for the number of

items shipped.

73
Q

A supplier may void part or all of an order on a triplicate DEA Form 222 by?

A

notifying the purchaser in writing

74
Q

The supplier must indicate the voiding on ___________ of the triplicate DEA Form 222 by drawing a line through the canceled item(s) and printing _________ in the space provided for the number of items shipped.

A

Copies 1 and 2, “canceled”

75
Q

If a purchaser ascertains that an unfilled triplicate DEA Form 222 has been lost what must they do?

A

the purchaser must execute another in triplicate and attach a statement containing the serial number and date of the lost form, and stating that the goods covered by the first triplicate DEA Form 222 were not received through loss of that triplicate DEA Form 222.

76
Q

If a purchaser ascertains that an unfilled triplicate DEA Form 222 has been lost what must they do with each copy of the new form?

A

Copy 3 of the second form and a copy of the statement must be retained with Copy 3 of the triplicate DEA Form 222 first executed. A copy of the statement must be attached to Copies 1 and 2 of the second triplicate DEA Form 222 sent to the supplier.

77
Q

If the first triplicate DEA Form 222 is subsequently received by the supplier to whom it was directed, what must the supplier do?

A

the supplier must mark upon the face “Not accepted” and return Copies 1 and 2 to the purchaser, who must attach it to Copy 3 and the statement.

78
Q

If the first triplicate DEA Form 222 is subsequently received by the supplier to whom it was directed but
the registrant no longer can use triplicate forms, then the registrant shall do what?

A

proceed by issuing a new single-sheet form in accordance with 21 CFR 1305.16. 21 CFR 1305.20(f)(1).

79
Q

Whenever any used or unused triplicate DEA Forms 222 are stolen or lost (other than in the course of transmission) by any purchaser or supplier, the purchaser or supplier must immediately upon discovery of the theft or loss, do what?

A

report the theft or loss to the Special Agent in Charge of the Drug Enforcement Administration in the local DEA Diversion Field Office.

80
Q

If the registration of any purchaser terminates (because the purchaser dies, ceases legal existence, discontinues business or professional practice, or changes the name or address as shown on the purchaser’s registration) or is suspended or revoked under 21 CFR 1301.36 of this chapter for all schedule I and II controlled substances for which the purchaser is registered, what must the purchaser do with their unused triplicate DEA Forms 222?

A

the purchaser must return all unused triplicate DEA Forms 222 to the Registration Section.

81
Q

Any registrant permitted to order schedule II controlled substances may do so electronically via the DEA’s Controlled Substance Ordering System (CSOS) and must maintain the records for how long?

A

they must maintain the records of these orders electronically for two years

82
Q

Is the use of electronic orders required?

A

The use of electronic orders is optional; registrants may continue to issue orders on a
paper DEA Form 222.

83
Q

What ordering system allows for secure electronic transmission of controlled substance orders without the supporting paper DEA Form 222?

A

CSOS

84
Q

What is the only electronic means of ordering schedule II controlled substances between controlled substance manufacturers, distributors, pharmacies, and other DEA authorized entities?

A

CSOS

85
Q

CSOS uses Public Key Infrastructure (PKI) technology, which ______ CSOS users to obtain a CSOS digital certificate for electronic ordering.

A

requires

86
Q

CSOS electronic orders must be signed using a digital signature issued by

A

the Certification Authority (CA) run by DEA.

87
Q

Digital certificates can be obtained only by

A

the person who signed the most recent DEA registration application or renewal application, a person authorized to sign a registration application, or a person granted power of attorney by a DEA registrant to sign orders for
one or more schedules of controlled substances

88
Q

A registrant must appoint a CSOS coordinator who will serve as that registrant’s recognized agent regarding what issues?

A

issues pertaining to issuance of, revocation of, and changes to digital certificates issued under that registrant’s DEA registration.

89
Q

A CSOS digital certificate is valid until when?

A

the DEA registration under which it is issued expires or until the CSOS CA is notified that the certificate should be revoked.

90
Q

CSOS digital Certificates will be revoked if the certificate holder is

A

no longer authorized to sign schedule II orders for the registrant, if the information on which the certificate is based changes, or if the digital certificate used to sign electronic orders has been compromised, stolen, or lost.

91
Q

A “Questions and Answers” page about the CSOS certificate is available on what website?

A

DEA’s ECommerce Program website at www.DEAecom.gov.

92
Q

Applicants can download the Diversion PKI CSOS Enrollment document and the CSOS Subscriber’s Manual for assistance on the enrollment process. DEA maintains a support line to assist applicants and subscribers with issues pertaining to

A

certificate enrollment, issuance, revocation, and renewal. Staff is available from 8:00 a.m. to 5:50 p.m. (Eastern Time), Monday through Friday at 1-877-332-3266 if further assistance is needed.

93
Q

Under 21 CFR 1305.25(a), an electronic order for controlled substances may not be filled if any of the following occurs:

A
  1. The required data fields have not been completed.
  2. The order is not signed using a digital certificate issued by DEA.
  3. The digital certificate used has expired or been revoked prior to signature.
  4. The purchaser’s public key will not validate the digital certificate.
  5. The validation of the order shows that the order is invalid for any reason.
94
Q

If an electronic order cannot be filled, the supplier must

A

notify the purchaser and provide a statement as to the reason (e.g., improperly prepared or altered).

95
Q

A supplier may, for any reason, refuse to accept any order. If a supplier refuses, what type of notification is sent?

A

a statement that the order is not accepted is sufficient.

96
Q

When a purchaser receives an unaccepted electronic order from the supplier, the purchaser must

A

electronically link the statement of non-acceptance to the original order.

97
Q

When a purchaser receives an unaccepted electronic order from the supplier the original statement and all linked records for that order must be retained for how long>

A

two years.

98
Q

When a purchaser receives an unaccepted electronic order from the supplier can a purchaser or a supplier may correct a defective order?

A

No

99
Q

When a purchaser receives an unaccepted electronic order from the supplier the purchaser ____ issue a new order for the order to be filled.

A

must

100
Q

A supplier may void all (or part) of an electronic order by

A

notifying the purchaser of the voiding.

101
Q

If the entire order is voided, the supplier must

A

make an electronic copy of the order and indicate “void” on the copy and return it to the purchaser.

102
Q

Is the suppler required to retain a record of orders that are not filled.

A

No

103
Q

Must the purchaser retain an electronic copy of the voided order?

A

Yes

104
Q

Should a supplier partially void an order, the supplier must

A

indicate in the linked record that nothing was shipped for each item voided.

105
Q

If a purchaser determines that an unfilled electronic order has been lost before or after receipt, the purchaser must provide, to the supplier, a signed statement. This statement must include

A

the unique tracking number and date of the lost order and state that the goods covered by the first order were not received through loss of that order

106
Q

If the purchaser executes a new order to replace the lost order, the purchaser must electronically link what?

A

an electronic record of the second order and a copy of the statement with the record of the first order and retain them both.

107
Q

If the supplier to whom the electronic order was directed subsequently receives the first order, the supplier must indicate that it is “Not Accepted” and return it to the
purchaser. The purchaser must then

A

link the returned order to the record of that order and the statement.

108
Q

When ordering Schedules III-V Controlled Substances

the registrant must keep a receipt (invoice or packing slip) on which it records what information?

A

the date the drugs were received and confirm that the order is accurate.

109
Q

When ordering Schedules III-V Controlled Substances
the registrant must keep a receipt (invoice or packing slip), pursuant to 21 CFR 1304.22(c), 1304.22(a)(2), such receipts must also contain the following information:

A
  1. The name of the substance;
  2. Each finished form (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or and the number of units in the
    commercial container (e.g., 100-tablet bottle or 3-milliliter vial);
  3. The number of units of finished forms and/or commercial containers acquired from other persons, including the date of and number of units and/or commercial containers in each acquisition to inventory and the name, address, and registration number of the person from whom the units were acquired;
  4. The number of commercial containers distributed to other persons,
  5. The number of units of finished forms and/or commercial containers distributed or disposed of in any other manner by the registran
110
Q

When ordering Schedules III-V Controlled Substances
the registrant must keep a receipt (invoice or packing slip) in addition, these receipts must be maintained either __________ from all other records of
the registrant or in such form that the information required is readily retrievable from the
ordinary business records of the registrant.

A

separately

Pharm Law Iowa (8 decks)

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