New Single-Sheet Format for U.S. Official Order Form for Schedule I and II Controlled Substances (DEA Form 222), 51368-51377 [2019-21021]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 84, Number 189 (Monday, September 30, 2019)]
[Rules and Regulations]
[Pages 51368-51377]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21021]



[[Page 51368]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1305

[Docket No. DEA-453]
RIN 1117-AB44


New Single-Sheet Format for U.S. Official Order Form for Schedule 
I and II Controlled Substances (DEA Form 222)

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: The Drug Enforcement Administration (DEA) is amending its 
regulations to implement a new single-sheet format for DEA Form 222, 
used by DEA registrants to order schedules I and II controlled 
substances. The rule provides for a two-year transition period, during 
which the existing triplicate version of the forms may continue to be 
used. The rule also includes a number of minor procedural changes.

DATES: This rule is effective October 30, 2019.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 362-
8209.

SUPPLEMENTARY INFORMATION: 

Legal Authority and Background

    The Controlled Substances Act (CSA) grants the Attorney General 
authority to promulgate rules and regulations relating to the 
registration and control of the manufacture, distribution, and 
dispensing of controlled substances; maintenance and submission of 
records and reports; and for the efficient execution of his statutory 
functions. 21 U.S.C. 821, 827, 871(b). The Attorney General is further 
authorized by the CSA to promulgate rules and regulations relating to 
the registration and control of importers and exporters of controlled 
substances. 21 U.S.C. 958(f). The Attorney General has delegated this 
authority to the Administrator of the DEA. 28 CFR 0.100(b).
    The DEA originally published a notice of proposed rulemaking (NPRM) 
on this matter in the Federal Register on November 27, 2007. 72 FR 
66118. On February 21, 2019, the DEA issued another NPRM, 84 FR 5395, 
superseding the 2007 NPRM. The DEA now finalizes the 2019 NPRM, with a 
number of minor changes.

Discussion of Comments

    DEA received twelve comments on the 2019 NPRM, copies of which are 
available online at www.regulations.gov. The commenters included 
individuals, pharmaceutical distributors, retail pharmacies, 
pharmaceutical companies, and associations representing retail 
pharmacies and pharmacists. The DEA thanks all commenters for their 
thoughtful questions and suggestions, and appreciates their input 
during the rulemaking process.
    Two comments were general statements of support for the rule, with 
no discussion of the proposed regulatory changes. Another comment 
stated that adopting ``the single-sheet form would make sense only if 
security measures are in place,'' but supported the rule, saying that 
``all-important concerns have been addressed,'' and noting that the 
rule would result in a net cost savings. Of the remaining comments, 
most sought clarification of certain provisions in the proposed rule or 
recommended additional changes. Several comments expressed support for 
various provisions in the proposed rule. Only one comment explicitly 
opposed the rule. The substantive comments received, along with DEA's 
responses, will be discussed below.

Power of Attorney Issues

    Comment: Multiple commenters raised issues relating to the proposed 
changes to the power of attorney (POA) provisions in 21 CFR 1305.05(d). 
The comments focused on which persons would be authorized to sign a 
POA, and how POAs may be signed.
    Under the current rules, Sec.  1305.05(d) requires that a POA be 
signed by four people: The person who signed the registrant's most 
recent application for DEA registration or reregistration, the person 
to whom the POA is being granted, and two witnesses. The proposed 
amendment to Sec.  1305.05(d) would require that this first signature 
be made not by the person who in fact signed the most recent 
application for DEA registration or reregistration, but instead by any 
person directly authorized to sign such an application under Sec.  
1301.13(j): By the registrant, if an individual; by a partner of the 
registrant, if a partnership; or by an officer of the registrant, if a 
corporation, corporate division, association, trust or other entity. 
Multiple commenters recognized, and supported, that this amendment 
would allow a broader range of individuals to sign POAs, but expressed 
concerns that it would not include one type of person currently 
authorized to sign. Under the existing rules, if, e.g., an officer of a 
corporation executes a POA under Sec.  1301.13(j) to authorize a non-
officer to sign applications for registration and reregistration on 
behalf of the corporation, and that individual has signed the most 
recent application, then that individual may also sign a POA under 
Sec.  1305.05, despite not being an officer of the corporation. Under 
the proposed change to Sec.  1305.05(d), this person would no longer be 
authorized to sign a POA. Multiple commenters suggested the DEA update 
the final rule to continue to allow persons in this situation to sign 
POAs in addition to permitting those individuals with expanded 
authority to sign a POA identified in the proposed Sec.  1305.05(d).
    Response: Given the significance of Form 222 signature authority, 
and the potential for diversion when that authority is abused, the DEA 
deems it appropriate to require an officer, a partner, or the 
registrant him- or herself to sign POAs under Sec.  1305.05. The DEA 
appreciates that this change may require some registrants to update 
their business processes to ensure POAs are signed by the appropriate 
persons, but POAs are effective until revoked, and registrants would 
only need to execute a single POA under the new rule to authorize the 
person who signed the most recent application for registration.
    Comment: A few of the commenters, who raised concerns about the 
expanded authority for signing a POA, also requested changes to Sec.  
1305.05(d) to allow POAs to be signed electronically as an alternative 
to a written signature on a hard-copy form. Commenters stated 
electronic signatures are a secure and traceable method of signing 
documents, and are already commonly accepted in commercial 
transactions. Commenters also stated that electronic signature systems 
are able to accommodate witness signatures, but that given the security 
features of electronic signatures, witness signatures are not needed 
when a document is signed electronically.
    Response: Electronic signatures are a widely accepted form of 
signature both in the government and the private sector, and the DEA 
agrees that allowing electronic signatures on POAs under Sec.  1305.05 
is a reasonable way of giving registrants more flexibility in the 
execution process. However, the requirement to have two witness 
signatures on a POA is essential to preventing diversion, and the DEA 
does not believe that electronic signatures are an adequate substitute 
for that requirement because they do not offer the necessary safeguards 
against diversion. Requiring two additional

[[Page 51369]]

parties to confirm the validity of a POA significantly reduces the risk 
of a fraudulent POA being used to divert controlled substances, or 
otherwise disrupt the closed system of distribution. Therefore, the 
witness requirement will be kept in place, but witnesses may sign a POA 
electronically, if the electronic signature technology used has this 
capability. This final rule adds Sec.  1305.05(f) to explicitly allow 
electronic signatures for POAs, but does not make any changes to the 
witness signature requirement. This final rule also includes some non-
substantive changes to that section to improve clarity.

Anonymous Comment

    Comment: An anonymous commenter stated that the proposed rule 
conflicts with the requirements of 21 U.S.C. 828(d)(1) as it requires 
purchasers to make a copy of a submitted order form ``on a form 
provided by the [A]ttorney [G]eneral.'' The commenter stated that DEA 
should petition Congress to change section 828 before the DEA changes 
the triplicate form to a single-sheet form. This commenter also stated 
that, with the DEA no longer providing forms to be used to create 
copies, the rule would impose costs on registrants, not reduce their 
costs.
    Response: The DEA does not interpret the provisions of 21 U.S.C. 
828(d)(1) to preclude the single-sheet framework proposed in the NPRM. 
The language of section 828(d)(1) is broad enough to allow for 
regulations permitting registrants to create a photocopy of a Form 222, 
or indeed to create an electronic copy and not retain any paper form at 
all. Section 828(d)(1) only states that the Attorney General (delegated 
to the Administrator of the DEA) must issue order forms pursuant to 21 
U.S.C. 828(a) and (c)(2). Section 828(c)(2) requires distributors of 
controlled substances in schedule I or II to use a form issued by the 
Administrator and ``make or cause to be made a duplicate thereof'' on 
such form. The DEA interprets section 828(d)(1) to mean that the 
distributor must make a copy; it does not mean that the issued form 
itself must be a form with carbon copies. Therefore, the DEA does not 
interpret the proposed rule's change to the Form 222 to necessitate any 
changes to section 828.
    Regarding the economic impact of the rule, while it does impose 
certain costs on affected registrants, the DEA estimates it will result 
in a net cost savings for purchasers, dispensing suppliers, and non-
dispensing suppliers of between $312 and $336 per entity per year.\1\
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    \1\ More information about the economic impact of this rule can 
be found in the Regulatory Flexibility Act section, below.
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Comment by Healthcare Distribution Alliance (HDA)

    Comment: HDA noted that Sec.  1305.13(a) as amended in the proposed 
rule is not explicit as to when the purchaser must make a copy of the 
Form 222. HDA stated that they believe the DEA's intent was for the 
purchaser to make a copy before submitting the form to a supplier, and 
that they support the provision under that reading.
    Response: HDA is correct that under the proposed rule, a purchaser 
would be required to make a copy of the original Form 222 before 
submitting it to a supplier. Since the supplier would retain the 
original for its records, the purchaser would not have an opportunity 
to create a copy after submitting the original to the supplier. The 
regulatory text in Sec.  1305.13(a) has been updated in this final rule 
to make this requirement explicit.
    Comment: HDA also recommended updating Sec.  1305.13(b) to not 
require suppliers that are required to report acquisition/disposition 
transactions to the Automation of Reports and Consolidated Orders 
System (ARCOS) to create a copy of the original Form 222. As drafted in 
the proposed rule, Sec.  1305.13(b) required suppliers to ``record on 
the original and a copy their DEA registration number'' and other 
information, regardless of whether the supplier needed to submit a copy 
of the form to the DEA. By removing ``and a copy'' from this section, 
only suppliers who do not report to ARCOS would be required to create a 
copy of the original, per proposed Sec.  1305.13(d).
    Response: The DEA agrees that removing ``and a copy'' from Sec.  
1305.13(b) would help clarify that ARCOS-reporting suppliers are not 
required to make a copy of the original Form 222. This final rule 
updates Sec.  1305.13(b) accordingly.
    Comment: Relatedly, HDA commented that while the proposed rule 
specified that purchasers would be permitted to make an electronic copy 
of a Form 222 to keep for their records, the proposed rule did not 
explicitly state whether suppliers could retain the original Form 222 
in an electronic form, instead of the paper original itself. HDA 
suggested the DEA clarify this issue, and allow suppliers to retain the 
original Form 222 in an electronic form.
    Response: The proposed rule was clear that under the proposed 
changes to Sec.  1305.13, suppliers would be required to retain the 
original of a Form 222, and could not fulfill their recordkeeping 
responsibilities by retaining a copy, whether paper or electronic. 
HDA's comment suggests allowing suppliers to retain the original Form 
222 ``in an electronic form,'' but this amounts to nothing more than 
creating an electronic copy. The original form is on paper, and so the 
only way to retain the original is to retain that same paper form. The 
new single-sheet Form 222 is designed with multiple security features 
that would not be preserved in a copy, paper or electronic. Retaining 
the original forms and making them available for inspection is 
necessary in order to maintain the closed system of distribution and to 
prevent diversion. Since the DEA is not changing the requirement that 
suppliers must retain the original Form 222 for their records, and may 
not retain a copy, whether paper or electronic, no changes have been 
made to this provision in this final rule.
    Comment: HDA's comment also included a suggestion to increase the 
number of order lines on the form, provided that this could be done 
without reducing legibility or requiring the form to be larger than 
8.5'' x 11'', and recommended the DEA coordinate with the Food and Drug 
Administration (FDA) to ensure the single-sheet Form 222 can 
accommodate any changes to the National Drug Code (NDC) format 
currently being considered.
    Response: The new form will include 20 order lines, double the 
previous number, and will fit on a standard 8.5'' x 11'' sheet. The DEA 
is aware of the pending changes to the NDC format, and, although no 
changes are being made to the NDC field on the new Form 222, the DEA 
will be monitoring the FDA's rulemaking on the matter, and will update 
the Form 222 as necessary in the future. Based on the current state of 
that rulemaking, any changes to the NDC format would only require minor 
modifications to the single-sheet Form 222.
    Comment: Finally, HDA offered a number of comments related to the 
electronic Controlled Substances Ordering System (CSOS).
    Response: While the DEA appreciates these comments, changes to CSOS 
are outside the scope of this rulemaking.

Comment by CVS Health

    Comment: CVS Health commented that the DEA should further explain 
the procedure in 21 CFR 1305.11(c) for signing and dating an electronic 
requisition for new Form 222, and clarify that signing and dating is 
not

[[Page 51370]]

required for electronic requisition requests, but that registrants 
instead must comply with DEA requirements for using the DEA secured 
network connection.
    Response: CVS Health is correct that registrants are not required 
to sign or date electronic requisition requests made through a DEA 
secured network connection. Nor are registrants required to provide 
their address on such requests. Section 1305.11(c) has been updated in 
this final rule to reflect this.
    Comment: CVS Health further suggested that, in the regulatory text 
of the final rule, the DEA explicitly state that purchasers are 
permitted to retain their copies of Forms 222 as electronic scanned 
images.
    Response: The DEA agrees an explicit statement authorizing 
purchasers to retain electronic copies of Forms 222 would improve 
clarity, and Sec.  1305.13(a) has been updated in this final rule to 
include such a statement.
    Comment: CVS Health also asked how purchasers should record the 
number of containers and date received from the supplier, if the 
purchaser has retained an electronic copy of the order form, noting 
that printing out the electronic copy, filling it out with the receipt 
information, and rescanning it is a somewhat inefficient process. CVS 
Health suggested adding a provision to the final rule allowing 
purchasers to create an electronic file with the receipt information 
and ``electronically link'' this file to the electronic copy of the 
Form 222, provided that the information is readily retrievable upon 
request.
    Response: The DEA appreciates that some registrants' records 
systems may process order forms in this way, or in a way that poses a 
similar inefficiency. However, creating a separate file for order 
receipt data would significantly complicate the inspection process. 
With double the number of records for DEA investigators to review 
during an inspection, this would add additional complexity, and 
consequently time and expense, to the enforcement process, and risk 
increasing diversion. Therefore, although requiring the order receipt 
data to be entered onto the copy of the Form 222 may, in some cases, 
require purchasers to take additional steps when processing the order, 
the DEA deems this necessary to prevent diversion and protect the 
public health and safety.
    Comment: Finally, CVS Health recommended updating Sec.  1305.17(c) 
to clarify that the requirement to maintain Forms 222 separately from 
all other records does not apply when a purchaser stores its copy of a 
form electronically.
    Response: Given the nature of electronic records systems, the DEA 
agrees that electronic copies of 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 Forms 222 separately from all other 
records may be met, for electronic copies, by storing them in such a 
way that they can be readily retrieved separately from all other 
records. Purchasers must be able, during an inspection or upon other 
DEA requests, to readily retrieve their electronic copies of Forms 222, 
with any related statements or other documents, and without any other 
records. Section 1305.17(e) has been added in this final rule to make 
this requirement clear.

Comment by Costco

    Comment: As discussed above, Costco requested changes to Sec.  
1305.05(d) to allow POAs to be signed electronically, and to not 
require witness signatures when a POA is signed electronically.
    Response: As discussed above, this final rule adds a provision 
allowing a POA under Sec.  1305.05 to be signed electronically, but 
retains the requirement that such POAs be signed by two witnesses.

Comment by National Association of Chain Drug Stores (NACDS)

    Comment: NACDS' comment discussed the POA provisions of the 
proposed rule, but also requested that the final rule allow pharmacies 
to continue to requisition Forms 222 using Form 222a. NACDS indicated 
this would be helpful in situations where pharmacies need more forms 
than allotted or when there is a need beyond the normal demand. NACDS 
stated that this method of requisition would be in addition to those 
specified in the proposed rule.
    Response: While the DEA appreciates the importance of offering 
registrants multiple options for requisitioning Forms 222, Form 222a 
has been out of use for some time. The requisition options in the 
proposed rule--through a DEA secured network connection, by contacting 
any Division Office, or by contacting the Registration Section through 
the customer service center--should be sufficiently broad to 
accommodate the vast majority of registrants, without requiring the 
time and expense of maintaining an outdated form.

Comment by Novartis

    Comment: After briefly touching on the POA issues discussed above, 
Novartis' comment asked how many forms could be requisitioned per 
registration type, and whether there would be a particular data source 
(e.g., ARCOS) that would be used to determine that number based on 
business activity.
    Response: Currently, registrants are asked to provide a written 
explanation of need if the number of Forms 222 requested in a given 
requisition request exceeds a particular number (not made public, for 
security reasons), unique to each business activity. The proposed rule 
did not include any changes to the default numbers for each business 
activity, or how a registrant's business activity is determined for 
these purposes. This final rule does not make any changes to these 
policies either, and under the new rules registrants may continue to 
requisition Forms 222 in the same numbers as under current practice. 
Registrants will still be asked to provide a written explanation when 
more than the default number of forms is requested.
    Comment: Novartis also asked whether the proposed rule would 
include any change to how Forms 222 are ordered in bulk, and if so, 
what the new procedure would be.
    Response: The proposed rule included no substantive changes to the 
bulk ordering process. The rule gave three ways to requisition order 
forms--through a DEA secured network connection, by contacting any 
Division Office, or by contacting the Registration Section through the 
customer service center--but registrants will provide the same 
information in the same format as under existing practice.
    Comment: Novartis sought additional information on the details of 
the new form, specifically: Whether it would be printed on color paper 
or in color ink; if so, whether a black and white copy would satisfy 
the purchaser's recordkeeping requirements; what type of paper stock 
the form would be printed on; and whether a sample of the new form 
would be made available to registrants. Novartis stated that 
registrants using electronic ordering systems will need time to update 
their systems before adopting the new single-sheet form. Novartis 
stated it would take six to eight months to update its own system.
    Response: The new Form 222 will be printed in color on white 8.5'' 
x 11'', 24 pound paper stock. A black and white copy of the form is 
sufficient to meet the purchaser's recordkeeping obligations. A sample 
of the new form can be obtained by request, using the contact 
information first provided above, and is included in the information 
collection request associated with this rulemaking, available on 
www.reginfo.gov under

[[Page 51371]]

Office of Management and Budget (OMB) Control Number 1117-0010. With 
respect to registrants needing to update their electronic ordering 
systems to accommodate the new single-sheet format, the DEA appreciates 
that it will take time to implement the necessary changes; this is why 
the proposed rule included a two-year transition period. Registrants 
may continue to use existing stocks of triplicate Forms 222 while they 
update their ordering systems, to avoid any disruptions.

Comment by Kroger Health

    Comment: As discussed above, Kroger Health suggested the DEA update 
Sec.  1305.05(d) to expand the range of people authorized to sign a 
POA. Kroger Health also suggested changes to Sec.  1305.05 to allow 
POAs to be signed electronically, and to not require witness signatures 
when a POA is signed electronically.
    Response: As discussed above, this final rule retains the 
requirement that POAs under Sec.  1305.05 be signed by an officer, a 
partner, or the registrant him- or herself, and does not expand this 
provision to include the person who signed the most recent application 
for registration. Additionally, this final rule adds a provision 
allowing a POA under Sec.  1305.05 to be signed electronically, but 
retains the requirement that such POAs be signed by two witnesses.

Comment by Janssen

    Comment: As discussed above, Janssen suggested the DEA update Sec.  
1305.05(d) to expand the range of people authorized to sign a POA.
    Response: As discussed above, this final rule retains the 
requirement that POAs under Sec.  1305.05 be signed by an officer, a 
partner, or the registrant him- or herself, and does not expand this 
provision to include the person who signed the most recent application 
for registration.

Comment by American Pharmacists Association (APhA)

    Comment: APhA sought clarification whether the handling and 
recordkeeping for triplicate Forms 222 during the transition period 
would remain the same as under the current rules, or if any of the 
proposed changes would apply.
    Response: In general, for triplicate forms used during the 
transition period, registrants should continue to use the same handling 
and recordkeeping procedures they use under the existing rules. The 
provisions in Sec.  1305.20 are the specific requirements applicable to 
the use of triplicate Forms 222 during the transition period, and are 
largely duplicative of the existing rules governing the use of 
triplicate forms. However, when Sec.  1305.20 is silent as to a 
particular requirement included in other sections of part 1305, those 
other sections are controlling. For example, the requirements for 
signing POAs in Sec.  1305.05 are not superseded by any provision in 
Sec.  1305.20; therefore, the new rules for who may sign a POA, and 
how, are applicable to the use of triplicate Forms 222 during the 
transition period.
    Comment: APhA recommended the DEA coordinate with the FDA to 
accommodate any changes to the NDC format.
    Response: As previously discussed, the DEA is monitoring FDA's 
rulemaking on this matter, and will update the new single-sheet Form 
222 as needed in the future.
    Comment: APhA stated that the proposed rule would require 
purchasers to ``make a copy (photocopy or scan)'' of executed Forms 222 
for their records, and would similarly allow ``dispensing suppliers'' 
to submit a copy of Form 222 to the DEA by fax or email. However, APhA 
noted that there were other methods of creating an electronic copies 
besides scanning. APhA encouraged the DEA to clarify that purchasers 
and suppliers would not be arbitrarily restricted in how they can 
create an electronic copy of Forms 222, and that capturing an image of 
a form using, e.g., a smartphone, would be deemed to meet the 
recordkeeping requirements of the rule.
    Response: The DEA agrees registrants should be permitted to make an 
electronic copy of Forms 222 in any reasonable method, and the 
regulatory text in the proposed rule did not indicate otherwise. 
Photocopying and scanning were given in the preamble as two possible 
methods of creating a copy, but are not the only methods that would be 
allowed. The proposed changes to the regulatory text in Sec.  
1305.13(a) did not restrict registrants to only photocopying or 
scanning, so no changes are needed in the final rule to give 
registrants the flexibility APhA suggested.
    Also, as is discussed below, the DEA is removing fax as an option 
for submitting copies of Forms 222 to the DEA. The DEA believes the 
cost of providing this submission option would outweigh the marginal 
benefit to the few registrants who would submit copies by fax.
    Comment: Finally, APhA stated it approves of the DEA's decision to 
allow purchasers to retain either the original of the single-sheet Form 
222 or a ``readily retrievable'' copy of the form for their records. 
APhA stated this flexibility would be more efficient and reduce costs, 
and encouraged the DEA to keep this provision in the final rule.
    Response: The terms of the proposed rule would not allow purchasers 
to retain the original of a Form 222 for their records, and the DEA is 
not updating these terms in this final rule to allow purchasers to do 
so. As the proposed amendments to Sec.  1305.13(a) clearly stated, the 
original of the single-sheet Form 222 must be submitted to the 
supplier. The purchaser must create a copy of the original form and 
retain the copy for its records. The purchaser does not have the option 
of retaining the original. The proposed amendments to Sec.  1305.13(d) 
clearly stated that suppliers must keep the original of the Form 222 on 
file. The preamble to the proposed rule also made clear that purchasers 
would make and retain a copy of the Form 222, and suppliers would 
retain the original.\2\ These requirements have not been changed in 
this final rule, and therefore no changes to the relevant regulatory 
text have been made.
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    \2\ 84 FR 5395 at 5397 (Feb. 21, 2019) (``[purchasers] would be 
required to complete and retain a copy of the form and send the 
original to their supplier for filling. The supplier would be 
required to record certain information related to the filling on the 
original and retain such original'').
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Changes in the Final Rule

    This final rule makes a number of substantive changes to the 
provisions of the proposed rule, as well as some non-substantive 
corrections and style edits to improve clarity. Regulatory text 
referring to registrants as ``he or she,'' ``him or her,'' or in 
similar ways has been updated to reflect that purchasers may be 
corporate entities. The substantive changes to the regulatory text are 
listed below.

Section 1305.05

    As discussed in the comment analysis section, above, Sec.  
1305.05(f) has been added to permit electronic signatures on POAs 
executed under that section. The witness requirement remains in place, 
but witnesses are permitted to sign a POA electronically.
    This final rule also includes some non-substantive changes to Sec.  
1305.05(d) to improve clarity.

Section 1305.11

    As discussed in the comment analysis section, above, Sec.  
1305.11(c) has been updated to reflect that registrants are not 
required to sign or date Form 222 requisition requests, or to provide 
their address with such requests.

[[Page 51372]]

Section 1305.13

    As discussed in the comment analysis section, above, Sec.  
1305.13(a) has been updated to make explicit that purchasers must make 
a copy of the original Form 222 for their records before forwarding the 
original to the supplier, and that purchasers may retain either paper 
or electronic copies of Forms 222 for their records.
    As discussed in the comment responses, above, Sec.  1305.13(b) has 
been updated to not require ARCOS-reporting suppliers to create and 
fill out copies of Forms 222 in addition to the originals.
    Section 1305.13(d) has been updated to remove fax as one of the 
options for submitting copies of completed Forms 222 to the DEA. On 
further review, the DEA believes the cost of providing this submission 
option would outweigh the marginal benefit to the few registrants who 
would submit copies by fax. Even if fax submission were permitted, the 
DEA believes that the vast majority of registrants would use the other 
options available--mail and email. Removing fax submissions as an 
option will simplify the processing of Form 222 copies for DEA, though 
excepted cost savings of this change are minimal.

Section 1305.17

    As discussed in the comment responses, above, Sec.  1305.17(e) has 
been added in this final rule to clarify that the requirement to 
maintain copies of Forms 222 separately from all other records may be 
met, for electronic copies, by storing them in such a way that they are 
readily retrievable separately from all other records.
    Additionally, newly added Sec.  1305.17(e) also includes a 
provision allowing electronic copies of Forms 222 to be stored at a 
location different from the registered location, provided such forms 
are readily retrievable at the registered location upon request. This 
will give purchasers more flexibility in utilizing electronic records 
systems while still ensuring the inspection process is not unduly 
hindered by complex recordkeeping arrangements.

Section 1305.18

    Section 1305.18 has been updated to properly reflect the 
requirements of Sec.  1301.52(c), which directs registrants 
discontinuing business activities with respect to controlled substances 
to return all unexecuted Forms 222 to the Registration Section at DEA 
headquarters. Section 1305.18 currently states that unused Forms 222 
should be returned to the nearest DEA office. This final rule resolves 
this conflict by updating Sec.  1305.18 to require registrants to 
return all unused Forms 222 to the Registration Section. The current 
mailing address for the Registration Section may be found in 21 CFR 
1321.01.

Section 1305.20

    Section 1305.20(h) has been updated to provide that unused 
triplicate Forms 222 should be returned to the Registration Section at 
DEA headquarters. This matches the new language in Sec.  1305.18, and 
resolves the conflict with Sec.  1301.52(c).
    The introductory text to Sec.  1305.20 has been updated to make 
clear that even if registrants still have a supply of triplicate Forms 
222 available after the two-year transition period, they must switch to 
using the new single-sheet Form 222 at that point.

Regulatory Analysis

    The DEA conducted a regulatory analysis of the final rule to 
determine how its provisions will impact registrants and the DEA. The 
results of this analysis are outlined below.

Executive Orders 12866 (Regulatory Planning and Review), 13563 
(Improving Regulation and Regulatory Review), and 13771 (Reducing 
Regulation and Controlling Regulatory Costs)

    This final rule was developed in accordance with the principles of 
Executive Orders 12866, 13563 and 13771. Executive Order 12866 directs 
agencies to assess all costs and benefits of available regulatory 
alternatives and, if regulation is necessary, to select regulatory 
approaches that maximize net benefits (including potential economic, 
environmental, public health, and safety effects; distributive impacts; 
and equity). Executive Order 13563 is supplemental to and reaffirms the 
principles, structures, and definitions governing regulatory review as 
established in Executive Order 12866. Executive Order 12866 classifies 
a ``significant regulatory action,'' requiring review by OMB, as any 
regulatory action that is likely to result in a rule that may: (1) Have 
an annual effect on the economy of $100 million or more or adversely 
affect in a material way the economy, a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local, or tribal governments or communities; (2) 
create a serious inconsistency or otherwise interfere with an action 
taken or planned by another agency; (3) materially alter the budgetary 
impact of entitlements, grants, user fees, or loan programs or the 
rights and obligations of recipients thereof; or (4) raise novel legal 
or policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in the Executive Order.
    1. The DEA expects that this regulatory action will not have an 
annual effect on the economy of $100 million or more in at least one 
year and therefore is not an economically significant regulatory 
action. DEA's analysis finds that this final rule will result in an 
annual cost-savings of $25.9 million; approximately $22.1 million to 
purchasers (persons executing DEA Form 222s) primarily due to 
efficiencies gained from having more lines per form, anticipated 
reduction of instances of form failure, allowing the use of a printer, 
and general ease of use; approximately $0.2 million to non-dispensing 
suppliers (manufacturers and distributors) due to the elimination of 
the requirement that registrants mail copies of their completed order 
forms to their DEA field office; $2.9 million to dispensing suppliers 
due to having the option to scan and email completed order forms; and 
$0.8 million to the DEA from reduction in cost of forms production, 
postage, and equipment maintenance.
    2. This regulatory action is not likely to result in a rule that 
may create a serious inconsistency or otherwise interfere with an 
action taken or planned by another agency.
    3. This regulatory action is not likely to result in a rule that 
may materially alter the budgetary impact of entitlements, grants, user 
fees, or loan programs or the rights and obligations of recipients 
thereof.
    4. This regulatory action is not likely to result in a rule that 
may raise novel legal or policy issues arising out of legal mandates, 
the President's priorities, or the principles set forth in the 
Executive Order.
    This final rule is estimated to have a total cost savings of $25.9 
million. Although this final rule is not a significant regulatory 
action under Executive Order 12866, this final rule is expected to be 
an Executive Order 13771 deregulatory action.
    An economic analysis of this rule can be found in the rulemaking 
docket at https://www.regulations.gov.

Executive Order 12988, Civil Justice Reform

    This final rule meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice 
Reform to eliminate ambiguity, minimize litigation, establish clear 
legal standards, and reduce burden.

[[Page 51373]]

Executive Order 13132, Federalism

    This final rule does not have federalism implications warranting 
the application of Executive Order 13132. The final rule does not have 
substantial direct effects on the States, on the relationship between 
the national government and the States, or the distribution of power 
and responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This final rule does not have substantial direct effects on the 
States, on the relationship between the national government and the 
States, or the distribution of power and responsibilities between the 
Federal Government and Indian tribes.

Regulatory Flexibility Act

    The Administrator hereby certifies that this final rule has been 
drafted, in accordance with the Regulatory Flexibility Act (RFA) (5 
U.S.C. 605(b)), and by approving it, certifies that this rule will not 
have a significant economic impact upon a substantial number of small 
entities.
    In accordance with the RFA, the DEA evaluated the impact of this 
rule on small entities. The DEA is amending its regulations to 
implement a new single-sheet format for order forms (DEA Form 222) 
which are issued by the DEA to DEA registrants to allow them to order 
schedule I and/or II controlled substances. The DEA is also making a 
number of minor procedural changes, including, among other things, who 
can issue the power of attorney that is required for others to sign DEA 
Form 222. This final rule affects all parties (purchaser and suppliers) 
to transactions where a DEA Form 222 is used.
    Based on its records, the DEA estimates that 71,481 entities are 
affected by this rule, which consists of 336 manufacturers, 378 
distributors, 31,887 pharmacies, 7,980 hospitals and clinics and 30,900 
practitioners. The DEA estimates that 65,984 (92.3%) of the total 
71,481 affected entities are small entities (312 manufacturers, 364 
distributors, 31,217 pharmacies, 3,716 hospitals and clinics and 30,375 
practitioners). The estimated economic impact varies for purchasers and 
suppliers, and among the suppliers, dispensing suppliers and non-
dispensing suppliers.
    ``Purchasers'' are registrants (primarily pharmacies, 
practitioners, hospitals and clinics) who execute DEA Form 222 to order 
schedules I and II controlled substances. The use of the new single 
sheet form will require purchasers to make a copy (paper or electronic) 
prior to submission to a supplier at an estimated cost of $0.22 per 
form, or a total of $734,646 per year. However, some cost savings are 
expected due to efficiencies gained from the new form. Key advantages 
include: (1) Reduction in number of forms executed due to increased 
number of lines per form, (2) reduction in form failure due to upgraded 
high-quality secure paper (fewer incidences of tears, carbon not 
copying through, improper tear of perforated edges, etc.), and (3) 
increased efficiency in completing the form due to ability to use a 
computer printer to fill the form (in addition to the existing 
allowable methods of typewriter, pen, or indelible pencil). Purchasers, 
as a group, are anticipated to save $22,794,750, for a net savings of 
$22,060,104, or $312 per entity.
    ``Dispensing suppliers'' are individual or institutional 
practitioners (e.g., physicians, pharmacies, hospitals, clinics, etc.) 
that are registered to dispense a controlled substance and may also 
distribute (without being registered to distribute) a quantity of such 
substance to another practitioner using a DEA Form 222. The final rule 
will allow the dispensing supplier to submit their copy of the order 
form to the DEA via email, as an alternative to submitting it by mail. 
Assuming dispensers will opt for the less costly scan and email method, 
based on an estimated 17,480 dispensing suppliers, the DEA estimates 
the dispensing suppliers, as a group, will save $2,861,977 per year or 
$164 per supplier.
    ``Non-dispensing suppliers'' are persons registered with the DEA as 
manufacturers or distributors of controlled substances listed in 
schedules I or II. The final rule and new form will remove the 
requirement to ship their copies of the received order forms to their 
DEA field office at the end of each month. The DEA estimates, by 
removing this requirement, the non-dispensing suppliers, as a group 
will save $239,657 per year, or $336 per entity.
    In summary, the final rule is estimated to save purchasers, 
dispensing suppliers, and non-dispensing suppliers, $312, $164, and 
$336 per entity per year, respectively. The DEA uses 3% of annual 
revenue as threshold for ``significant economic impact.'' The annual 
revenue at which $312, $164, and $336 is 3% equates to $10,400, $5,467, 
and $11,200, respectively. The DEA estimates the annual revenues of 
purchasers, dispensing suppliers, and non-dispensing suppliers are 
greater than $10,400, $5,467, and $11,200, respectively, resulting in 
an economic impact of less than 3% of annual revenue.
    Therefore, the DEA's evaluation of economic impact by size category 
indicates that the rule will not have a significant economic impact on 
a substantial number of small entities.

Unfunded Mandates Reform Act of 1995

    This final rule will not result in the expenditure by State, local 
and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted for inflation) in any one year, and will 
not significantly or uniquely affect small governments. Therefore, no 
actions were deemed necessary under the provisions of the Unfunded 
Mandates Reform Act of 1995, 2 U.S.C. 1532.

Paperwork Reduction Act of 1995

    Pursuant to section 3507(d) of the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501 et seq.), the DEA has identified the following 
collections of information related to this final rule. A person is not 
required to respond to a collection of information unless it displays a 
valid OMB control number. Copies of existing information collections 
approved by OMB may be obtained at https://www.reginfo.gov/public/do/PRAMain.

A. Collections of Information Associated With the Final Rule

    Title: U.S. Official Order Forms for Schedules I & II Controlled 
Substances (Accountable Forms), Order Form Requisition.
    OMB Control Number: 1117-0010.
    Form Number: DEA-222.
    The DEA Form 222 provides the DEA with oversight and control over 
the distribution of schedules I and II controlled substances. The form 
is the only document that can authorize the distribution of schedules I 
and II controlled substances within the closed system of distribution. 
The DEA is amending its regulations to implement a new single-sheet 
format for order forms (DEA Form 222) which are issued by DEA to DEA 
registrants to allow them to order schedule I and/or II controlled 
substances. Currently, the DEA Form 222 is a triplicate form with 
interleaved carbon paper.
    The new single-sheet format is expected to lower labor burden due 
to efficiencies gained from having more lines per form, anticipated 
reduction of instances of form failure, allowing the

[[Page 51374]]

use of a printer, and general ease of use. Additionally, this rule 
removes the requirement for ARCOS-reporting suppliers to mail completed 
order forms to the DEA field offices. Finally, this rule will also 
allow suppliers that do not report to ARCOS (generally dispensers who 
distribute) to submit completed order forms to DEA headquarters via 
mail or email.
    DEA registrants will be allowed to exhaust their supply of the 
current forms as part of the transition to using the new single-sheet 
form. When a registrant's supply of triplicate forms is depleted, the 
DEA will issue the registrant the new single-sheet forms. This rule 
includes a ``sunset date''--a date after which use of the triplicate 
forms will not be allowed--of October 30, 2021.
    This rule does not impact those who use the electronic equivalent 
order form. Since the proposed rule, the DEA has adjusted its 
methodology to estimate the amount of online responses relative to 
paper responses to account for the additional ordering lines included 
on the new paper form. As a result, the estimated number of online 
responses has decreased, but the average burden per response has 
increased, so the total annual hour burden estimate remains the same. 
The DEA now estimates the following number of respondents and burden 
associated with this collection of information (which includes DEA Form 
222 and the electronic equivalent):
     Number of respondents: 125,435.
     Frequency of response: 42.7 per respondent per year 
(average).
     Number of responses: 5,350,000 (3,300,000 paper DEA Form 
222; 2,050,000 electronic equivalent).
     Burden per response: $0.1925.
     Total annual hour burden: 1,030,000.
    Since this rule eliminates the requirement that suppliers mail 
completed DEA Forms 222 to their local DEA field offices, the cost 
burden associated with that requirement is also eliminated. However, 
this rule requires purchasers to make copies of the new single-sheet 
Form 222 before submitting the original to the supplier; the DEA 
estimates this printing/copying will have a cost burden of $130,350.
    If you need a copy of the information collection instrument(s) with 
instructions or additional information, please contact the Regulatory 
Drafting and Policy Support Section (DPW), Diversion Control Division, 
Drug Enforcement Administration; Mailing Address: 8701 Morrissette 
Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.
    Any additional comments on this collection of information may be 
sent in writing to the Office of Information and Regulatory Affairs, 
OMB, Attention: Desk Officer for DOJ, Washington, DC 20503. Please 
state that your comment refers to OMB Control Number 1117-0010.

Congressional Review Act

    This final rule is not a major rule as defined by the Congressional 
Review Act (CRA), 5 U.S.C. 804. This final rule will not result in an 
annual effect on the economy of $100,000,000 or more; a major increase 
in costs or prices; or significant adverse effects on competition, 
employment, investment, productivity, innovation, or on the ability of 
United States-based companies to compete with foreign-based companies 
in domestic and export markets. Accordingly, this final rule is not 
subject to the reporting requirements under the CRA.

List of Subjects in 21 CFR Part 1305

    Drug traffic control, Reporting and recordkeeping requirements.

    For the reasons set forth above, the DEA amends 21 CFR part 1305 as 
follows:

PART 1305--ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES

0
1. The authority citation for part 1305 continues to read as follows:

    Authority:  21 U.S.C. 821, 828, 871(b), unless otherwise noted.


0
2. Amend Sec.  1305.05 by revising paragraph (d) and adding paragraph 
(f) to read as follows:


Sec.  1305.05  Power of attorney.

* * * * *
    (d) A power of attorney must be executed by:
    (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.
* * * * *
    (f) A power of attorney executed under this section may be signed 
electronically, by any or all of the persons required to sign.

0
3. Revise Sec.  1305.11 to read as follows:


Sec.  1305.11  Procedure for obtaining DEA Forms 222.

    (a) DEA Forms 222 are issued in mailing envelopes containing a 
predetermined number of forms based on the business activity of the 
registrant, each form consisting of one single-sheet. 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.
    (b) Any person with an active registration that is authorized to 
order schedule I and II controlled substances is entitled to obtain a 
DEA Form 222, which will be supplied at any time after the DEA 
registration is granted. Any person holding a registration authorizing 
the person to obtain a DEA Form 222 may requisition the forms through a 
DEA secured network connection or by contacting any Division Office or 
the Registration Section of the Administration through the customer 
service center.
    (c) Each requisition must show the name, address, and registration 
number of the registrant and the number of DEA Forms 222 desired.
    (d) DEA Forms 222 will have an order form number and be 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; the registrant must 
report any errors to the local Division Office or the Registration 
Section of the Administration to modify the registration.

0
4. Amend Sec.  1305.12 by revising paragraph (a) to read as follows:


Sec.  1305.12  Procedure for executing DEA Forms 222.

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

0
5. Amend Sec.  1305.13 by revising paragraphs (a), (b), (d), and (e) to 
read as follows:


Sec.  1305.13  Procedure for filling DEA Forms 222.

    (a) A purchaser must make a copy of the original DEA Form 222 for 
its records and then submit the original to the supplier. The copy 
retained by the purchaser may be in paper or electronic form.
    (b) A supplier may fill the order, if possible and if the supplier 
desires to do so, and must record on the original DEA Form 222 its DEA 
registration number and 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

[[Page 51375]]

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.
* * * * *
    (d) The supplier must retain the original DEA Form 222 for the 
supplier's files in accordance with Sec.  1305.17(c). Any supplier who 
is not required to report acquisition/disposition transactions to the 
Automation of Reports and Consolidated Orders System (ARCOS) under 
Sec.  1304.33(c) (such as a practitioner) must make and submit a copy 
of the original DEA Form 222 to DEA, either by mail to the Registration 
Section, or by email to [email protected]. The copy must be 
forwarded 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.
    (e) The purchaser must record on its copy 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.
* * * * *

0
6. Amend Sec.  1305.14 by revising the first two sentences of paragraph 
(a) and paragraph (b) to read as follows:


Sec.  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 Sec.  
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 in Part 3 on the 
original DEA Form 222) the DEA number of the second supplier, and must 
be signed and dated by a person authorized to obtain and execute DEA 
Forms 222 on behalf of the first supplier. * * *
    (b) Distributions made on endorsed DEA Forms 222 must be reported 
by the second supplier in the same manner as all other distributions.

0
7. Amend Sec.  1305.15 by revising paragraphs (b) and (d) to read as 
follows:


Sec.  1305.15  Unaccepted and defective DEA Forms 222.

* * * * *
    (b) If a DEA Form 222 cannot be filled for any reason under this 
section, the supplier must return the original DEA Form 222 to the 
purchaser with a statement as to the reason (e.g., illegible or 
altered).
* * * * *
    (d) When a purchaser receives an unaccepted order, the original DEA 
Form 222 and the statement must be retained in the files of the 
purchaser in accordance with Sec.  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.

0
8. Amend Sec.  1305.16 by revising paragraphs (a) and (d) to read as 
follows:


Sec.  1305.16  Lost and stolen DEA Forms 222.

    (a) If a purchaser ascertains that an unfilled DEA Form 222 has 
been lost, 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. 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 the 
original DEA Form 222 to the purchaser, who must attach it to the 
statement.
* * * * *
    (d) If any DEA Forms 222 are lost or stolen, and the purchaser is 
unable to state the order form numbers of the DEA Forms 222, the 
purchaser must report, in lieu of numbers of the forms, the date or 
approximate date of issuance.
* * * * *

0
9. Amend Sec.  1305.17 by revising paragraphs (a), (b), and (c) and 
adding paragraph (e) to read as follows:


Sec.  1305.17  Preservation of DEA Forms 222.

    (a) The purchaser must retain a copy of each executed DEA Form 222 
and all copies of unaccepted or defective forms with each statement 
attached.
    (b) The supplier must retain the original 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 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 Sec.  1305.12(e)), at the registered location printed 
on the DEA Form 222.
* * * * *
    (e) Electronic copies of DEA Forms 222 will be deemed to be 
maintained separately from all other records of the registrant, for the 
purposes of this section, if such copies are readily retrievable 
separately from all other records. Electronic copies of DEA Forms 222 
may be stored on a system at a location different from the registered 
location, provided such copies are readily retrievable at the 
registered location.

0
10. Revise Sec.  1305.18 to read as follows:


Sec.  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 suspended or revoked under Sec.  
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 Registration Section.

0
11. Amend Sec.  1305.19 by revising paragraph (a) to read as follows:


Sec.  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 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.
* * * * *

0
12. Add Sec.  1305.20 to read as follows:


Sec.  1305.20  Transition provisions allowing continued use of existing 
stocks of triplicate DEA Forms 222.

    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 use the new single-sheet DEA Form 222. The provisions 
of this part are applicable to the use of triplicate forms, except for 
the specific rules as provided in this section.
    (a) Procedure for obtaining triplicate DEA Forms 222. The DEA will 
no longer issue triplicate forms. Triplicate DEA

[[Page 51376]]

Forms 222 will not be accepted after October 30, 2021.
    (b) Procedure for executing triplicate DEA Forms 222. (1) A 
purchaser must prepare and execute a triplicate DEA Form 222 
simultaneously by means of interleaved carbon sheets that are part of 
the triplicate DEA Form 222. Triplicate DEA Form 222 must be prepared 
by use of a typewriter, pen, or indelible pencil.
    (2) 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. Triplicate DEA Forms 222 for carfentanil, 
etorphine hydrochloride, and diprenorphine must contain only these 
substances.
    (3) 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.
    (4) Each triplicate 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 DEA Form 222 under Sec.  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.
    (5) Unexecuted DEA Forms 222 may be kept and may be executed at a 
location 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.
    (c) Procedure for filling triplicate DEA Forms 222. (1) A purchaser 
must submit Copy 1 and Copy 2 of the triplicate DEA Form 222 to the 
supplier and retain Copy 3 in the purchaser's files.
    (2) 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 triplicate DEA Form 222. No triplicate DEA Form 222 is valid more 
than 60 days after its execution by the purchaser, except as specified 
in paragraph (c)(6) of this section.
    (3) The controlled substances must be shipped only to the purchaser 
and the location printed by the Administration on the triplicate DEA 
Form 222, except as specified in paragraph (c)(6) of this section.
    (4) The supplier must retain Copy 1 of the triplicate DEA Form 222 
for his or her files in accordance with paragraph (g)(3) of this 
section 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.
    (5) The purchaser must record on Copy 3 of the triplicate 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.
    (6) DEA triplicate Forms 222 submitted by registered procurement 
officers of the Defense Supply Center of the Defense Logistics Agency 
for delivery to armed services establishments within the United States 
may be shipped to locations other than the location printed on the 
triplicate 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.
    (d) Procedure for endorsing triplicate DEA Forms 222. (1) A 
triplicate 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 
paragraph (c) of this section, may be endorsed to another supplier for 
filling. The endorsement must be made only by the supplier to whom the 
triplicate DEA Form 222 was first made, must state (in the spaces 
provided on the reverse sides of Copies 1 and 2 of the triplicate DEA 
Form 222) the name and address of the second supplier, and must be 
signed by a person authorized to obtain and execute triplicate 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 paragraphs (c)(2) through (4) of this section, 
including shipping all substances directly to the purchaser.
    (2) Distributions made on endorsed triplicate DEA Forms 222 must be 
reported by the second supplier in the same manner as all other 
distributions.
    (e) Unaccepted and defective triplicate DEA Forms 222. (1) A 
triplicate DEA Form 222 must not be filled if either of the following 
apply:
    (i) The order is not complete, legible, or properly prepared, 
executed, or endorsed.
    (ii) The order shows any alteration, erasure, or change of any 
description.
    (2) If a triplicate 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).
    (3) 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.
    (4) When a purchaser receives an unaccepted order, Copies 1 and 2 
of the triplicate DEA Form 222 and the statement must be attached to 
Copy 3 and retained in the files of the purchaser in accordance with 
paragraph (g) of this section. A defective triplicate DEA Form 222 may 
not be corrected; it must be replaced by a new triplicate DEA Form 222 
for the order to be filled.
    (f) Lost and stolen triplicate DEA Forms 222. (1) If a purchaser 
ascertains that an unfilled triplicate DEA Form 222 has been lost, 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. 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. If the first triplicate 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. 
However, if the registrant no longer can use triplicate forms, then the 
registrant shall proceed by issuing a new single-sheet form in 
accordance with Sec.  1305.16.
    (2) 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, 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,

[[Page 51377]]

stating the serial number of each form stolen or lost.
    (3) If the theft or loss includes any original triplicate DEA Forms 
222 received from purchasers and the supplier is unable to state the 
serial numbers of the triplicate DEA Forms 222, the supplier must 
report the date or approximate date of receipt and the names and 
addresses of the purchasers.
    (4) If an entire book of triplicate DEA Forms 222 is lost or 
stolen, and the purchaser is unable to state the serial numbers of the 
triplicate 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.
    (5) If any unused triplicate 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.
    (g) Preservation of triplicate DEA Forms 222. (1) The purchaser 
must retain Copy 3 of each executed triplicate DEA Form 222 and all 
copies of unaccepted or defective forms with each statement attached.
    (2) The supplier must retain Copy 1 of each triplicate DEA Form 222 
that it has filled.
    (3) Triplicate DEA Forms 222 must be maintained separately from all 
other records of the registrant. Triplicate 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 triplicate DEA Form 222 and any attached 
statements or other related documents (not including unexecuted 
triplicate DEA Forms 222, which may be kept elsewhere under paragraph 
(b)(5) of this section), at the registered location printed on the 
triplicate DEA Form 222.
    (4) The supplier of thiafentanil, carfentanil, etorphine 
hydrochloride, and diprenorphine must maintain triplicate DEA Forms 222 
for these substances separately from all other DEA triplicate Forms 222 
and records required to be maintained by the registrant.
    (h) Return of unused triplicate 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 
suspended or revoked under Sec.  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 triplicate DEA Forms 
222 to the Registration Section.
    (i) Cancellation and voiding of triplicate DEA Forms 222. (1) A 
purchaser may cancel part or all of an order on a triplicate 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 
triplicate DEA Form 222 by drawing a line through the canceled items 
and printing ``canceled'' in the space provided for the number of items 
shipped.
    (2) A supplier may void part or all of an order on a triplicate 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 (i)(1) of this section.

    Dated: September 23, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-21021 Filed 9-27-19; 8:45 am]
 BILLING CODE 4410-09-P