New Single-Sheet Format for U.S. Official Order Form for Schedule I and II Controlled Substances (DEA Form 222)
| Published date | 30 September 2019 |
| Record Number | 2019-21021 |
| Section | Rules and Regulations |
| Court | Drug Enforcement Administration |
Federal Register, Volume 84 Issue 189 (Monday, September 30, 2019)
[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 http://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
