21 Cfr 1305

§ 1304.50

21 CFR Ch. II (4–1–18 Edition)
(1) 100 or more prescriptions for controlled substances filled; or
(2) 5,000 or more dosage units dispensed of all controlled substances
combined.
(b) Each online pharmacy shall report a negative response if, during a
given calendar month, its total dispensing of controlled substances falls
below both of the thresholds in paragraph (a) of this section.
(c) The reporting requirements of
this section apply to every pharmacy
that, at any time during a calendar
month, holds a modified registration
authorizing it to operate as an online
pharmacy, regardless of whether the
online pharmacy dispenses any controlled substances by means of the
Internet during the month.
(d) Reports will be submitted to DEA
electronically via online reporting,
electronic file upload, or other means
as approved by DEA.
(e) Reports shall be filed every month
not later than the fifteenth day of the
month succeeding the month for which
they are submitted.
(f) An online pharmacy filing a report
under paragraph (a) of this section
shall utilize the National Drug Code
number assigned to the product under
the National Drug Code System of the
Food and Drug Administration, and indicate the total number of dosage units
dispensed for each such National Drug
Code number.
(g) Records required to be kept under
this section must be kept by the registrant for at least two years from the
date of such records. The information
shall be readily retrievable from the
ordinary business records of the registrant and available for inspection and
copying by authorized employees of the
Administration.

§ 1304.50 Disclosure requirements for
Web sites of nonpharmacy practitioners that dispense controlled
substances by means of the Internet.
For a Web site to identify itself as
being exempt from the definition of an
online pharmacy by virtue of section
102(52)(B)(ii) of the Act (21 U.S.C.
802(52)(B)(ii)) and § 1300.04(h)(2) of this
chapter, the Web site shall post in a
visible and clear manner on its homepage, or on a page directly linked
thereto in which the hyperlink is also
visible and clear on the homepage, a
list of the DEA-registered nonpharmacy practitioners who are affiliated
with the Web site. Any nonpharmacy
practitioner affiliated with such a Web
site is responsible for compliance with
this section. An institutional practitioner that otherwise complies with
the requirements of the Act and this
chapter will be deemed to meet the requirements of this section if, in lieu of
posting the names of each affiliated individual practitioner, it posts its name
(as it appears on its Certificate of Registration) in a visible and clear manner
on its homepage and in a manner that
identifies itself as being responsible for
the operation of the Web site.
[74 FR 15623, Apr. 6, 2009]

nshattuck on DSK9F9SC42PROD with CFR

§ 1304.55 Reports
macies.

by

online

phar-

(a) Each online pharmacy shall report to the Administrator the total
quantity of each controlled substance
that the pharmacy has dispensed each
calendar month. The report must include the total quantity of such dispensing by any means, regardless of
whether the controlled substances are
dispensed by means of the Internet.
Thus, such reporting shall include all
controlled substances dispensed via
Internet
transactions,
mail-order
transactions, face-to-face transactions,
or any other means. However, the pharmacy is not required to describe in its
report to the Administrator such
means of dispensing. Such reporting is
required for every calendar month in
which the total quantity of controlled
substances dispensed by the pharmacy
meets or exceeds one of the following
thresholds:

[74 FR 15623, Apr. 6, 2009]

PART 1305—ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES
Subpart A—General Requirements
Sec.
1305.01 Scope of part 1305.
1305.02 Definitions.
1305.03 Distributions requiring a Form 222
or digitally signed electronic order.

88

VerDate Sep<11>2014

13:00 May 22, 2018

Jkt 244078

PO 00000

Frm 00098

Fmt 8010

Sfmt 8010

Y:\SGML\244078.XXX

244078

Drug Enforcement Administration, Justice
1305.04 Persons entitled to order Schedule I
and II controlled substances.
1305.05 Power of attorney.
1305.06 Persons entitled to fill orders for
Schedule I and II controlled substances.
1305.07 Special procedure for filling certain
orders.

§ 1305.03 Distributions
requiring
a
Form 222 or a digitally signed electronic order.
Either a DEA Form 222 or its electronic equivalent as set forth in subpart C of this part and Part 1311 of this
chapter is required for each distribution of a Schedule I or II controlled
substance except for the following:
(a) Distributions to persons exempted
from registration under Part 1301 of
this chapter.
(b) Exports from the United States
that conform with the requirements of
the Act.
(c) Deliveries to a registered analytical laboratory or its agent approved
by DEA.
(d) Delivery from a central fill pharmacy, as defined in § 1300.01 of this
chapter, to a retail pharmacy.
(e) Deliveries to an authorized DEA
registrant by an ultimate user, a longterm care facility on behalf of an ultimate user who resides or has resided at
that facility, or a person authorized to
dispose of the ultimate user decedent’s
property.
(f) Distributions to reverse distributors and distributors by collectors and
law enforcement pursuant to § 1317.55 of
this chapter.
(g) Deliveries of controlled substances from ultimate users for the
purpose of recalls pursuant to § 1317.85
of this chapter.

Subpart B—DEA Form 222
1305.11 Procedure for obtaining DEA Forms
222.
1305.12 Procedure for executing DEA Forms
222.
1305.13 Procedure for filling DEA Forms 222.
1305.14 Procedure for endorsing DEA Forms
222.
1305.15 Unaccepted and defective DEA
Forms 222.
1305.16 Lost and stolen DEA Forms 222.
1305.17 Preservation of DEA Forms 222.
1305.18 Return of unused DEA Forms 222.
1305.19 Cancellation and voiding of DEA
Forms 222.

Subpart C—Electronic Orders
1305.21 Requirements for electronic orders.
1305.22 Procedure for filling electronic orders.
1305.23 Endorsing electronic orders.
1305.24 Central processing of orders.
1305.25 Unaccepted and defective electronic
orders.
1305.26 Lost electronic orders.
1305.27 Preservation of electronic orders.
1305.28 Canceling and voiding electronic orders.
1305.29 Reporting to DEA.
AUTHORITY: 21 U.S.C. 821, 828, 871(b), unless
otherwise noted.

[70 FR 16911, Apr. 1, 2005, as amended at 77
FR 4235, Jan. 27, 2012; 79 FR 53564, Sept. 9,
2014]

SOURCE: 70 FR 16911, Apr. 1, 2005, unless
otherwise noted.

§ 1305.04 Persons entitled to order
Schedule I and II controlled substances.

Subpart A—General Requirements
§ 1305.01

(a) Only persons who are registered
with DEA under section 303 of the Act
(21 U.S.C. 823) to handle Schedule I or
II controlled substances, and persons
who are registered with DEA under section 1008 of the Act (21 U.S.C. 958) to
export these substances may obtain
and use DEA Form 222 (order forms) or
issue electronic orders for these substances. Persons not registered to handle Schedule I or II controlled substances and persons registered only to
import controlled substances are not
entitled to obtain Form 222 or issue
electronic orders for these substances.

Scope of part 1305.

Procedures governing the issuance,
use, and preservation of orders for
Schedule I and II controlled substances
are set forth generally by section 308 of
the Act (21 U.S.C. 828) and specifically
by the sections of this part.

nshattuck on DSK9F9SC42PROD with CFR

§ 1305.02

§ 1305.04

Definitions.

Any term contained in this part shall
have the definition set forth in the Act
or part 1300 of this chapter.

89

VerDate Sep<11>2014

13:00 May 22, 2018

Jkt 244078

PO 00000

Frm 00099

Fmt 8010

Sfmt 8010

Y:\SGML\244078.XXX

244078

§ 1305.05

21 CFR Ch. II (4–1–18 Edition)

(b) An order for Schedule I or II controlled substances may be executed
only on behalf of the registrant named
on the order and only if his or her registration for the substances being purchased has not expired or been revoked
or suspended.
§ 1305.05

fully do or cause to be done by virtue
hereof.
llllllllllllllllllllllll
(Signature of person granting power)

I, llll (name of attorney-in-fact),
hereby affirm that I am the person
named herein as attorney-in-fact and
that the signature affixed hereto is my
signature.
(signature of attorney-in-fact)

Power of attorney.

(a) A registrant may authorize one or
more individuals, whether or not located at his or her registered location,
to issue orders for Schedule I and II
controlled substances on the registrant’s behalf by executing a power of
attorney for each such individual, if
the power of attorney is retained in the
files, with executed Forms 222 where
applicable, for the same period as any
order bearing the signature of the attorney. The power of attorney must be
available for inspection together with
other order records.
(b) A registrant may revoke any
power of attorney at any time by executing a notice of revocation.
(c) The power of attorney and notice
of revocation must be similar to the
following format:

Witnesses:
1. llllll
2. llllll
Signed and dated on the llll day of
llll, (year), at llll .
Notice of Revocation
The foregoing power of attorney is
hereby revoked by the undersigned,
who is authorized to sign the current
application for registration of the
above-named registrant under the Controlled Substances Act or the Controlled Substances Import and Export
Act. Written notice of this revocation
has been given to the attorney-in-fact
llll this same day.
llllllllllllllllllllllll
(Signature of person revoking power)
Witnesses:
1. llllll
2. llllll
Signed and dated on the llll day of
llll, (year), at llll.

Power of Attorney for DEA Forms 222
and Electronic Orders

nshattuck on DSK9F9SC42PROD with CFR

llllllllllllllllllllllll
(Name of registrant)
llllllllllllllllllllllll
(Address of registrant)
llllllllllllllllllllllll
(DEA registration number)

(d) A power of attorney must be executed by the person who signed the
most recent application for DEA registration or reregistration; the person
to whom the power of attorney is being
granted; and two witnesses.
(e) A power of attorney must be revoked by the person who signed the
most recent application for DEA registration or reregistration, and two
witnesses.

I, llll (name of person granting
power), the undersigned, who am authorized to sign the current application
for registration of the above-named
registrant under the Controlled Substances Act or Controlled Substances
Import and Export Act, have made,
constituted, and appointed, and by
these presents, do make, constitute,
and appoint llll (name of attorneyin-fact), my true and lawful attorney
for me in my name, place, and stead, to
execute applications for Forms 222 and
to sign orders for Schedule I and II controlled substances, whether these orders be on Form 222 or electronic, in
accordance with 21 U.S.C. 828 and Part
1305 of Title 21 of the Code of Federal
Regulations. I hereby ratify and confirm all that said attorney must law-

§ 1305.06 Persons entitled to fill orders
for Schedule I and II controlled
substances.
An order for Schedule I and II controlled substances, whether on a DEA
Form 222 or an electronic order, may
be filled only by a person registered
with DEA as a manufacturer or distributor of controlled substances listed
in Schedule I or II pursuant to section
303 of the Act (21 U.S.C. 823) or as an

90

VerDate Sep<11>2014

13:00 May 22, 2018

Jkt 244078

PO 00000

Frm 00100

Fmt 8010

Sfmt 8010

Y:\SGML\244078.XXX

244078

Drug Enforcement Administration, Justice

nshattuck on DSK9F9SC42PROD with CFR

importer of such substances pursuant
to section 1008 of the Act (21 U.S.C.
958), except for the following:
(a) A person registered with DEA to
dispense the substances, or to export
the substances, if he/she is discontinuing business or if his/her registration is expiring without reregistration, may dispose of any Schedule
I or II controlled substances in his/her
possession with a DEA Form 222 or an
electronic order in accordance with
§ 1301.52 of this chapter.
(b) A purchaser who has obtained any
Schedule I or II controlled substance
by either a DEA Form 222 or an electronic order may return the substance
to the supplier of the substance with
either a DEA Form 222 or an electronic
order from the supplier.
(c) A person registered to dispense
Schedule II substances may distribute
the substances to another dispenser
with either a DEA Form 222 or an electronic order only in the circumstances
described in § 1307.11 of this chapter.
(d) A person registered or authorized
to conduct chemical analysis or research with controlled substances may
distribute a Schedule I or II controlled
substance to another person registered
or authorized to conduct chemical
analysis, instructional activities, or research with the substances with either
a DEA Form 222 or an electronic order,
if the distribution is for the purpose of
furthering the chemical analysis, instructional activities, or research.
(e) A person registered as a
compounder of narcotic substances for
use at off-site locations in conjunction
with a narcotic treatment program at
the compounding location, who is authorized to handle Schedule II narcotics, is authorized to fill either a
DEA Form 222 or an electronic order
for distribution of narcotic drugs to
off-site narcotic treatment programs
only.

§ 1305.11
by the Administrator to handle these
substances, may fill the order in accordance with the procedures set forth
in § 1305.17 except that:
(a) A DEA Form 222 or an electronic
order for thiafentanil, carfentanil,
etorphine
hydrochloride,
and
diprenorphine must contain only these
substances in reasonable quantities.
(b) The substances must be shipped,
under secure conditions using substantial packaging material with no markings on the outside that would indicate
the content, only to the purchaser’s
registered location.
[70 FR 16911, Apr. 1, 2005, as amended at 81
FR 58839, Aug. 26, 2016]

Subpart B—DEA Form 222
§ 1305.11 Procedure for obtaining DEA
Forms 222.
(a) DEA Forms 222 are issued in mailing envelopes containing either seven
or fourteen forms, each form containing an original, duplicate, and triplicate copy (respectively, Copy 1, Copy
2, and Copy 3). A limit, which is based
on the business activity of the registrant, will be imposed on the number
of DEA Forms 222, which will be furnished on any requisition unless additional forms are specifically requested
and a reasonable need for such additional forms is shown.
(b) Any person applying for a registration that would entitle him or her
to obtain a DEA Form 222 may requisition the forms by so indicating on the
application form; a DEA Form 222 will
be supplied upon the registration of the
applicant. Any person holding a registration entitling him or her to obtain
a DEA Form 222 may requisition the
forms for the first time by contacting
any Division Office or the Registration
Section of the Administration. Any
person already holding a DEA Form 222
may requisition additional forms on
DEA Form 222a, which is mailed to a
registrant approximately 30 days after
each shipment of DEA Forms 222 to
that registrant, or by contacting any
Division Office or the Registration Section of the Administration. All requisition forms (DEA Form 222a) must be
submitted to the DEA Registration
Section.

§ 1305.07 Special procedure for filling
certain orders.
A
supplier
of
thiafentanil,
carfentanil, etorphine hydrochloride,
or diprenorphine, if he or she determines that the purchaser is a veterinarian engaged in zoo and exotic animal practice, wildlife management programs, or research, and is authorized

91

VerDate Sep<11>2014

13:00 May 22, 2018

Jkt 244078

PO 00000

Frm 00101

Fmt 8010

Sfmt 8010

Y:\SGML\244078.XXX

244078

§ 1305.12

21 CFR Ch. II (4–1–18 Edition)

nshattuck on DSK9F9SC42PROD with CFR

(c) Each requisition must show the
name, address, and registration number of the registrant and the number of
books of DEA Forms 222 desired. Each
requisition must be signed and dated
by the same person who signed the
most recent application for registration or for reregistration, or by any
person authorized to obtain and execute DEA Forms 222 by a power of attorney under § 1305.05.
(d) DEA Forms 222 will be serially
numbered and issued with the name,
address, and registration number of the
registrant, the authorized activity, and
schedules of the registrant. This information cannot be altered or changed
by the registrant; any errors must be
corrected by the Registration Section
of the Administration by returning the
forms with notification of the error.

tion other than the registered location
printed on the form, provided that all
unexecuted
forms
are
delivered
promptly to the registered location
upon an inspection of the location by
any officer authorized to make inspections, or to enforce, any Federal, State,
or local law regarding controlled substances.
§ 1305.13 Procedure for filling DEA
Forms 222.
(a) A purchaser must submit Copy 1
and Copy 2 of the DEA Form 222 to the
supplier and retain Copy 3 in the purchaser’s files.
(b) A supplier may fill the order, if
possible and if the supplier desires to
do so, and must record on Copies 1 and
2 the number of commercial or bulk
containers furnished on each item and
the date on which the containers are
shipped to the purchaser. If an order
cannot be filled in its entirety, it may
be filled in part and the balance supplied by additional shipments within 60
days following the date of the DEA
Form 222. No DEA Form 222 is valid
more than 60 days after its execution
by the purchaser, except as specified in
paragraph (f) of this section.
(c) The controlled substances must be
shipped only to the purchaser and the
location printed by the Administration
on the DEA Form 222, except as specified in paragraph (f) of this section.
(d) The supplier must retain Copy 1
of the DEA Form 222 for his or her files
and forward Copy 2 to the Special
Agent in Charge of the Drug Enforcement Administration in the area in
which the supplier is located. Copy 2
must be forwarded at the close of the
month during which the order is filled.
If an order is filled by partial shipments, Copy 2 must be forwarded at the
close of the month during which the
final shipment is made or the 60-day
validity period expires.
(e) The purchaser must record on
Copy 3 of the DEA Form 222 the number of commercial or bulk containers
furnished on each item and the dates
on which the containers are received
by the purchaser.
(f) DEA Forms 222 submitted by registered procurement officers of the Defense Supply Center of the Defense Logistics Agency for delivery to armed

§ 1305.12 Procedure for executing DEA
Forms 222.
(a) A purchaser must prepare and
execute a DEA Form 222 simultaneously in triplicate by means of
interleaved carbon sheets that are part
of the DEA Form 222. DEA Form 222
must be prepared by use of a typewriter, pen, or indelible pencil.
(b) Only one item may be entered on
each numbered line. 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. The number of lines completed
must be noted on that form at the bottom of the form, in the space provided.
DEA Forms 222 for carfentanil,
etorphine
hydrochloride,
and
diprenorphine must contain only these
substances.
(c) The name and address of the supplier from whom the controlled substances are being ordered must be entered on the form. Only one supplier
may be listed on any form.
(d) Each DEA Form 222 must be
signed and dated by a person authorized to sign an application for registration or a person granted power of attorney to sign a Form 222 under
§ 1305.05. The name of the purchaser, if
different from the individual signing
the DEA Form 222, must also be inserted in the signature space.
(e) Unexecuted DEA Forms 222 may
be kept and may be executed at a loca-

92

VerDate Sep<11>2014

13:00 May 22, 2018

Jkt 244078

PO 00000

Frm 00102

Fmt 8010

Sfmt 8010

Y:\SGML\244078.XXX

244078

Drug Enforcement Administration, Justice
services establishments within the
United States may be shipped to locations other than the location printed
on the DEA Form 222, and in partial
shipments at different times not to exceed six months from the date of the
order, as designated by the procurement officer when submitting the
order.

(c) A supplier may for any reason
refuse to accept any order and if a supplier refuses to accept the order, a
statement that the order is not accepted is sufficient for purposes of this
paragraph.
(d) When a purchaser receives an
unaccepted order, Copies 1 and 2 of the
DEA Form 222 and the statement must
be attached to Copy 3 and retained in
the files of the purchaser in accordance
with § 1305.17. 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.

§ 1305.14 Procedure for endorsing DEA
Forms 222.
(a) A DEA Form 222, made out to any
supplier who cannot fill all or a part of
the order within the time limitation
set forth in § 1305.13, may be endorsed
to another supplier for filling. The endorsement must be made only by the
supplier to whom the DEA Form 222
was first made, must state (in the
spaces provided on the reverse sides of
Copies 1 and 2 of the DEA Form 222) the
name and address of the second supplier, and must be signed by a person
authorized to obtain and execute DEA
Forms 222 on behalf of the first supplier. The first supplier may not fill
any part of an order on an endorsed
form. The second supplier may fill the
order, if possible and if the supplier desires to do so, in accordance with
§ 1305.13(b), (c), and (d), including shipping all substances directly to the purchaser.
(b) Distributions made on endorsed
DEA Forms 222 must be reported by the
second supplier in the same manner as
all other distributions except that
where the name of the supplier is requested on the reporting form, the second supplier must record the name, address, and registration number of the
first supplier.

nshattuck on DSK9F9SC42PROD with CFR

§ 1305.15 Unaccepted
DEA Forms 222.

and

§ 1305.16

§ 1305.16 Lost and stolen DEA Forms
222.
(a) If a purchaser ascertains that an
unfilled DEA Form 222 has been lost,
he or she 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 DEA Form
222 were not received through loss of
that DEA Form 222. Copy 3 of the second form and a copy of the statement
must be retained with Copy 3 of the
DEA Form 222 first executed. A copy of
the statement must be attached to
Copies 1 and 2 of the second DEA Form
222 sent to the supplier. If the first
DEA Form 222 is subsequently received
by the supplier to whom it was directed, 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.
(b) Whenever any used or unused
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, report the theft or loss to the Special
Agent in Charge of the Drug Enforcement Administration in the Divisional
Office responsible for the area in which
the registrant is located, stating the
serial number of each form stolen or
lost.
(c) If the theft or loss includes any
original DEA Forms 222 received from
purchasers and the supplier is unable
to state the serial numbers of the DEA
Forms 222, the supplier must report the
date or approximate date of receipt and

defective

(a) A DEA Form 222 must not be
filled if either of the following apply:
(1) The order is not complete, legible,
or properly prepared, executed, or endorsed.
(2) The order shows any alteration,
erasure, or change of any description.
(b) If a DEA Form 222 cannot be filled
for any reason under this section, the
supplier must return Copies 1 and 2 to
the purchaser with a statement as to
the reason (e.g., illegible or altered).

93

VerDate Sep<11>2014

13:00 May 22, 2018

Jkt 244078

PO 00000

Frm 00103

Fmt 8010

Sfmt 8010

Y:\SGML\244078.XXX

244078

§ 1305.17

21 CFR Ch. II (4–1–18 Edition)

the names and addresses of the purchasers.
(d) If an entire book of DEA Forms
222 is lost or stolen, and the purchaser
is unable to state the serial numbers of
the DEA Forms 222 in the book, the
purchaser must report, in lieu of the
numbers of the forms contained in the
book, the date or approximate date of
issuance.
(e) If any unused DEA Form 222 reported stolen or lost is subsequently
recovered or found, the Special Agent
in Charge of the Drug Enforcement Administration in the Divisional Office
responsible for the area in which the
registrant is located must immediately
be notified.

suspended or revoked under § 1301.36 of
this chapter for all Schedule I and II
controlled substances for which the
purchaser is registered, the purchaser
must return all unused DEA Forms 222
to the nearest office of the Administration.
§ 1305.19 Cancellation and voiding of
DEA Forms 222.
(a) A purchaser may cancel part or
all of an order on a DEA Form 222 by
notifying the supplier in writing of the
cancellation. The supplier must indicate the cancellation on Copies 1 and 2
of the DEA Form 222 by drawing a line
through the canceled items and printing ‘‘canceled’’ in the space provided
for number of items shipped.
(b) A supplier may void part or all of
an order on a DEA Form 222 by notifying the purchaser in writing of the
voiding. The supplier must indicate the
voiding in the manner prescribed for
cancellation in paragraph (a) of this
section.

§ 1305.17 Preservation of DEA Forms
222.
(a) The purchaser must retain Copy 3
of each executed DEA Form 222 and all
copies of unaccepted or defective forms
with each statement attached.
(b) The supplier must retain Copy 1
of each DEA Form 222 that it has filled.
(c) DEA Forms 222 must be maintained separately from all other
records of the registrant. DEA Forms
222 are required to be kept available for
inspection for a period of two years. If
a purchaser has several registered locations, the purchaser must retain Copy 3
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 § 1305.12(e)), at the registered location printed on the DEA
Form 222.
(d) The supplier of thiafentanil,
carfentanil, etorphine hydrochloride,
and diprenorphine must maintain DEA
Forms 222 for these substances separately from all other DEA Forms 222
and records required to be maintained
by the registrant.

Subpart C—Electronic Orders
§ 1305.21 Requirements for electronic
orders.
(a) To be valid, the purchaser must
sign an electronic order for a Schedule
I or II controlled substance with a digital signature issued to the purchaser,
or the purchaser’s agent, by DEA as
provided in part 1311 of this chapter.
(b) The following data fields must be
included on an electronic order for
Schedule I and II controlled substances:
(1) A unique number the purchaser
assigns to track the order. The number
must be in the following 9-character
format: the last two digits of the year,
X, and six characters as selected by the
purchaser.
(2) The purchaser’s DEA registration
number.
(3) The name of the supplier.
(4) The complete address of the supplier (may be completed by either the
purchaser or the supplier).
(5) The supplier’s DEA registration
number (may be completed by either
the purchaser or the supplier).
(6) The date the order is signed.
(7) The name (including strength
where appropriate) of the controlled

nshattuck on DSK9F9SC42PROD with CFR

[70 FR 16911, Apr. 1, 2005, as amended at 81
FR 58839, Aug. 26, 2016]

§ 1305.18 Return of unused DEA Forms
222.
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

94

VerDate Sep<11>2014

13:00 May 22, 2018

Jkt 244078

PO 00000

Frm 00104

Fmt 8010

Sfmt 8010

Y:\SGML\244078.XXX

244078

Drug Enforcement Administration, Justice

nshattuck on DSK9F9SC42PROD with CFR

substance product or the National
Drug Code (NDC) number (the NDC
number may be completed by either
the purchaser or the supplier).
(8) The quantity in a single package
or container.
(9) The number of packages or containers of each item ordered.
(c) An electronic order may include
controlled substances that are not in
schedules I and II and non-controlled
substances.

§ 1305.24
the original order that the supplier
completes. Software used to handle
digitally signed orders must comply
with part 1311 of this chapter.
(e) If an order cannot be filled in its
entirety, a supplier may fill it in part
and supply the balance by additional
shipments within 60 days following the
date of the order. No order is valid
more than 60 days after its execution
by the purchaser, except as specified in
paragraph (h) of this section.
(f) A supplier must ship the controlled substances to the registered location associated with the digital certificate used to sign the order, except
as specified in paragraph (h) of this section.
(g) When a purchaser receives a shipment, the purchaser must create a
record of the quantity of each item received and the date received. The
record must be electronically linked to
the original order and archived.
(h) Registered procurement officers
of the Defense Supply Center of the Defense Logistics Agency may order controlled substances for delivery to
armed services establishments within
the United States. These orders may be
shipped to locations other than the
registered location, and in partial shipments at different times not to exceed
six months from the date of the order,
as designated by the procurement officer when submitting the order.

§ 1305.22 Procedure for filling electronic orders.
(a) A purchaser must submit the
order to a specific supplier. The supplier may initially process the order
(e.g., entry of the order into the computer system, billing functions, inventory identification, etc.) centrally at
any location, regardless of the location’s registration with DEA. Following centralized processing, the supplier may distribute the order to one or
more registered locations maintained
by the supplier for filling. The registrant must maintain control of the
processing of the order at all times.
(b) A supplier may fill the order for a
Schedule I or II controlled substance, if
possible and if the supplier desires to
do so and is authorized to do so under
§ 1305.06.
(c) A supplier must do the following
before filling the order:
(1) Verify the integrity of the signature and the order by using software
that complies with Part 1311 of this
chapter to validate the order.
(2) Verify that the digital certificate
has not expired.
(3) Check the validity of the certificate holder’s certificate by checking
the Certificate Revocation List. The
supplier may cache the Certificate
Revocation List until it expires.
(4) Verify the registrant’s eligibility
to order the controlled substances by
checking the certificate extension
data.
(d) The supplier must retain an electronic record of every order, and,
linked to each order, a record of the
number of commercial or bulk containers furnished on each item and the
date on which the supplier shipped the
containers to the purchaser. The linked
record must also include any data on

§ 1305.23

Endorsing electronic orders.

A supplier may not endorse an electronic order to another supplier to fill.
§ 1305.24

Central processing of orders.

(a) A supplier that has one or more
registered locations and maintains a
central processing computer system in
which orders are stored may have one
or more of the supplier’s registered locations fill an electronic order if the
supplier does the following:
(1) Assigns each item on the order to
a specific registered location for filling.
(2) Creates a record linked to the central file noting both which items a location filled and the location identity.
(3) Ensures that no item is filled by
more than one location.

95

VerDate Sep<11>2014

13:00 May 22, 2018

Jkt 244078

PO 00000

Frm 00105

Fmt 8010

Sfmt 8010

Y:\SGML\244078.XXX

244078

§ 1305.25

21 CFR Ch. II (4–1–18 Edition)

(4) Maintains the original order with
all linked records on the central computer system.
(b) A company that has central processing of orders must assign responsibility for filling parts of orders only to
registered locations that the company
owns and operates.

record of the second order and a copy
of the statement with the record of the
first order and retain them.
(c) If the supplier to whom the 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
link the returned order to the record of
that order and the statement.

nshattuck on DSK9F9SC42PROD with CFR

§ 1305.25 Unaccepted and defective
electronic orders.
(a) No electronic order may be filled
if:
(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 had
expired or had been revoked prior to
signature.
(4) The purchaser’s public key will
not validate the digital signature.
(5) The validation of the order shows
that the order is invalid for any reason.
(b) If an order cannot be filled for any
reason under this section, the supplier
must notify the purchaser and provide
a statement as to the reason (e.g., improperly prepared or altered). A supplier may, for any reason, refuse to accept any order, and if a supplier refuses
to accept the order, a statement that
the order is not accepted is sufficient
for purposes of this paragraph.
(c) When a purchaser receives an
unaccepted electronic order from the
supplier, the purchaser must electronically link the statement of nonacceptance to the original order. The original
order and the statement must be retained in accordance with § 1305.27.
(d) Neither a purchaser nor a supplier
may correct a defective order; the purchaser must issue a new order for the
order to be filled.

§ 1305.27 Preservation of electronic orders.
(a) A purchaser must, for each order
filled, retain the original signed order
and all linked records for that order for
two years. The purchaser must also retain all copies of each unaccepted or
defective order and each linked statement.
(b) A supplier must retain each original order filled and the linked records
for two years.
(c) If electronic order records are
maintained on a central server, the
records must be readily retrievable at
the registered location.
§ 1305.28 Canceling and voiding electronic orders.
(a) A supplier may void all or part of
an electronic order by notifying the
purchaser of the voiding. If the entire
order is voided, the supplier must make
an electronic copy of the order, indicate on the copy ‘‘Void,’’ and return it
to the purchaser. The supplier is not
required to retain a record of orders
that are not filled.
(b) The purchaser must retain an
electronic copy of the voided order.
(c) To partially void an order, the
supplier must indicate in the linked
record that nothing was shipped for
each item voided.
§ 1305.29 Reporting to DEA.
A supplier must, for each electronic
order filled, forward either a copy of
the electronic order or an electronic
report of the order in a format that
DEA specifies to DEA within two business days.

§ 1305.26 Lost electronic orders.
(a) 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
containing
the
unique
tracking number and date of the lost
order and stating that the goods covered by the first order were not received through loss of that order.
(b) If the purchaser executes an order
to replace the lost order, the purchaser
must electronically link an electronic

PART 1306—PRESCRIPTIONS
GENERAL INFORMATION
Sec.
1306.01

Scope of part 1306.

96

VerDate Sep<11>2014

13:00 May 22, 2018

Jkt 244078

PO 00000

Frm 00106

Fmt 8010

Sfmt 8010

Y:\SGML\244078.XXX

244078