[Federal Register Volume 85, Number 234 (Friday, December 4, 2020)]
[Proposed Rules]
[Pages 78282-78295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26291]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1306

[Docket No. DEA-469]
RIN 1117-AB45


Partial Filling of Prescriptions for Schedule II Controlled 
Substances

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of proposed rulemaking.

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SUMMARY: On July 22, 2016, the Comprehensive Addiction and Recovery Act 
of 2016 became law. One provision of the Comprehensive Addiction and 
Recovery Act of 2016 amended the Controlled Substances Act to allow for 
the partial filling of prescriptions for schedule II controlled 
substances under certain conditions. The Drug Enforcement 
Administration is hereby proposing to amend its regulations to conform 
to this new statutory provision and to set forth the corresponding 
regulatory requirements.

DATES: Electronic comments must be submitted, and written comments must 
be postmarked, on or before February 2, 2021. Commenters should be 
aware that the electronic Federal Docket Management System will not 
accept comments after 11:59 p.m. Eastern Time on the last day of the 
comment period.
    All comments concerning collections of information under the 
Paperwork Reduction Act must be submitted to the Office of Management 
and Budget (OMB) on or before February 2, 2021.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-469'' on all correspondence, including any 
attachments.
    DEA encourages that all comments be submitted through the Federal 
eRulemaking Portal, which provides the ability to type short comments 
directly into the comment field on the web page or to attach a file for 
lengthier comments. Please go to http://www.regulations.gov and follow 
the online instructions to submit comments. Upon submission of your 
comment, you will receive a Comment Tracking Number. Please be aware 
that submitted comments are not instantaneously available for public 
view on Regulations.gov. If you have received a Comment Tracking 
Number, your comment has been successfully submitted, and there is no 
need to resubmit the same comment. Paper comments that duplicate an 
electronic submission are not necessary and are discouraged. Should you 
wish to mail a

[[Page 78283]]

paper comment in lieu of an electronic comment, it should be sent via 
regular or express mail to: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152.
    All comments concerning collections of information under the 
Paperwork Reduction Act must be submitted to the Office of Information 
and Regulatory Affairs, OMB, Attention: Desk Officer for DOJ, 
Washington, DC 20503. Please state that your comment refers to RIN 
1117-AB45/Docket No. DEA-469.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting 
and Policy Section, Diversion Control Division, Drug Enforcement 
Administration; Mailing Address: 8701 Morrissette Drive, Springfield, 
Virginia 22152; Telephone: (571) 362-3261.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    Please note that all comments received in response to this docket 
are considered part of the public record. They will, unless reasonable 
cause is given, be made available by the Drug Enforcement 
Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying 
information (such as your name, address, etc.) voluntarily submitted by 
the commenter. The Freedom of Information Act applies to all comments 
received. If you want to submit personal identifying information (such 
as your name, address, etc.) as part of your comment, but do not want 
it to be made publicly available, you must include the phrase 
``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of your 
comment. You must also place the personal identifying information you 
do not want to be made publicly available in the first paragraph of 
your comment and identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information and 
confidential business information identified as directed above will 
generally be made publicly available in redacted form. If a comment has 
so much confidential business information or personal identifying 
information that it cannot be effectively redacted, all or part of that 
comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information 
(such as name, address, and phone number) or confidential business 
information included in the text of your electronic submission that is 
not identified as directed above as confidential.
    An electronic copy of this document is available at http://www.regulations.gov for easy reference.

Background and Statutory Authority

    On July 22, 2016, the President signed the Comprehensive Addiction 
and Recovery Act (CARA) of 2016 into law as Public Law 114-198. One of 
the provisions of the CARA amended the Controlled Substances Act (CSA) 
to allow for the partial filling of prescriptions for schedule II 
controlled substances under certain conditions. Specifically, the CARA 
amended 21 U.S.C. 829 by adding new subsection (f), which allows a 
pharmacist to partially fill a prescription for a schedule II 
controlled substance where requested by the prescribing practitioner or 
the patient. Subsection (f) further provides that for such partial 
filling to be lawful under the CSA, all of the following conditions 
must be satisfied: (1) The partial filling must not be prohibited by 
State law; (2) the prescription must be written and filled in 
accordance with the CSA, DEA regulations, and State law; and (3) the 
total quantity dispensed in all partial fillings must not exceed the 
total quantity prescribed. In addition, subsection (f) provides that 
the remaining portions of a partially filled prescription for a 
controlled substance in schedule II, if filled, must be filled no later 
than 30 days after the date on which the prescription is written, 
unless the prescription is issued as an emergency oral prescription, in 
which case the remaining portion, if filled, must be filled no later 
than 72 hours after it was issued.
    This proposed rule would revise DEA regulations to incorporate the 
foregoing new statutory provisions. In addition, DEA is proposing to 
further revise its regulations to address certain regulatory 
requirements not addressed by the CARA. In particular, the CARA does 
not address how the prescribing practitioner should indicate that a 
prescription for a schedule II controlled substance must be partially 
filled. Likewise, the CARA does not specify how a pharmacist should 
record the partial filling of such a prescription. The CARA provides 
that partial filling of schedule II prescriptions is permitted if the 
prescription is written and filled in accordance with, among other 
things, regulations issued by DEA. 21 U.S.C. 829(f)(1)(B). Accordingly, 
Congress gave DEA explicit authorization to fill in any gaps in the 
regulatory scheme not addressed by Congress itself in the CARA. DEA is 
exercising this authority by issuing this proposed rule, which is 
intended to give practitioners and pharmacists clear guidance in this 
area, and to allow for proper auditing by DEA.
    In addition, there is potential for benefit to patients and society 
as a result of this proposed rule. For patients, partial filling could 
lower the cost of prescriptions by reducing the quantity of unused 
schedule II controlled substances due to not needing to continue on 
drug therapy. For instance, a patient would not have to pay for filling 
an entire prescription when only a portion of the prescription is 
filled because there is a likelihood that the patient may not need to 
consume the maximum number of dosage units prescribed. Similarly, the 
patient's insurance company or other program paying for or subsidizing 
the cost of the patient's drugs (e.g., a pharmacy's co-pay plan or a 
government program such as Medicare or Medicaid), would avoid such 
unnecessary expense. Reducing the dispensing of schedule II drugs that 
are ultimately not needed would also help to ameliorate the danger that 
the patient might become dependent upon or addicted to dangerous 
opioids or other schedule II drugs. The existence of unused drugs in 
U.S. households contributes to growing rates of prescription drug abuse 
among Americans. Keeping and storing unused medications in households 
pose several dangers related to diversion, accidental overdose, and 
consumption of spoiled substances.\1\ Reducing the quantity of unused 
schedule II controlled substances would reduce the risk of diversion.
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    \1\ ``Safe Disposal of Unused Controlled Substances: Current 
Challenges and Opportunities for Reform,'' Avalere, http://www.ncdoi.com/osfm/safekids/documents/omd/safedisposalofunusedcontrolledsubstancesreport.pdf.
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    There are a number of reasons unused drugs remain in U.S. 
households. For example, in one survey of 139 respondents, patients 
cited the following: condition resolved/symptoms improved (42.4 
percent); did not believe I needed to take it (12.9 percent); did not 
feel it was helping the condition (7.1 percent); experienced side 
effects (6.5 percent); forgot or did not get around to taking it (5.8 
percent); person on medications no longer lives there (5.0

[[Page 78284]]

percent); physician asked to stop it (4.3 percent); or other reason 
(15.8 percent).\2\
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    \2\ ``Taking Stock of Medication Wastage: Unused Medications in 
U.S. Households.'' NeuroImage, Academic Press, 16 Oct. 2014. 
www.sciencedirect.com/science/article/pii/S1551741114003337?via%3Dihub.
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    In recent years, a number of states have enacted laws placing 
limits on certain controlled substances that may be prescribed. DEA has 
received inquiries from pharmacists and others asking whether it is 
permissible under Federal law to fill a schedule II prescription that 
is otherwise valid, but which exceeds the quantitative limit under 
State law. The CARA provides that partial filling of schedule II 
prescriptions is permitted if the prescription is written and filled in 
accordance with, among other things, State law. 21 U.S.C. 829(f)(1)(B). 
DEA interprets a prescription written for a quantity that exceeds the 
limits of State law to be invalid, and therefore, the prescription may 
not be filled as written. Because such a prescription is invalid, it 
also cannot be partially filled as a means of getting around the limits 
imposed by State law.

Partial Fill Request by Practitioner

How a Practitioner May Request That a Prescription Be Partially Filled 
Under the Proposed Rule

    The proposed rule states that where a practitioner issues a 
prescription for a schedule II controlled substance and wants the 
prescription to be partially filled (as the CARA now allows), the 
practitioner must specify the quantity to be dispensed in the partial 
filling on the face of the written prescription, in the written record 
of the emergency oral prescription, or in the electronic prescription 
record. This information would need to be included on the prescription, 
along with other information required for issuing a prescription under 
21 CFR 1306.05, at the time it is signed by the practitioner, and in 
the case of an emergency oral prescription, when communicated by the 
prescribing practitioner to the pharmacist. DEA proposes this approach 
to ensure that the practitioner's intent regarding partial filling is 
made clear to the pharmacist, and will be properly memorialized in the 
dispensing records.

How a Pharmacy Would Be Required To Record the Partial Filling of a 
Prescription for a Schedule II Controlled Substance When Requested By 
the Prescribing Practitioner

    When presented with a prescription on which the prescribing 
practitioner has properly specified his/her intent that the 
prescription for a schedule II controlled substance be partially 
filled, the proposed rule would require the pharmacist to record the 
partial filling in a manner similar to that required under the existing 
regulations for other circumstances.\3\ Specifically, upon each such 
partial filling requested by a prescribing practitioner, the dispensing 
pharmacist must make a notation of the quantity dispensed on the face 
of the written prescription, in the written record of the emergency 
oral prescription, or in the electronic prescription record (as is 
currently required under 21 CFR 1306.13(a) when the pharmacist is 
unable to supply the full quantity called for in the prescription). For 
electronic prescriptions, there must be an electronic prescription 
record, and the record must be permanently attached to the electronic 
prescription. Also, for each such partial filling, the pharmacy must 
maintain a record with the date of each dispensing, the name or 
initials of the individual who dispensed the substance, and all other 
information required by 21 CFR 1306.22(c) for schedule III and IV 
prescription refills. For electronic prescriptions specifically, 
pharmacy applications must allow required information pertaining to the 
quantity, date, and the dispenser to be linked to each electronic 
controlled substance prescription record (as currently required by 21 
CFR 1311.205(b)(10)).
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    \3\ Longstanding DEA regulations, which would not be changed by 
this proposed rule, also allow the partial filling of a schedule II 
prescription where the pharmacist is unable to supply the full 
quantity called for in the prescription (Sec.  1306.13(a)) and for a 
patient in a long-term care facility or with a terminal illness 
(Sec.  1306.13(b) and (c)).
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Partial Fill Request by Patient

How a Patient May Request the Partial Filling of a Schedule II 
Prescription

    As a result of the CARA, 21 U.S.C. 829(f) now provides that a 
prescription for a schedule II controlled substance may be partially 
filled at the request of either the prescriber or the patient. Thus, 
even if the prescribing practitioner does not specify on the 
prescription his/her intent that the prescription be partially filled, 
the patient may make such request to the pharmacy. The CARA does not 
place any limitations on how the patient may make a partial fill 
request. In addition, DEA recognizes that many post-surgery patients 
may have a difficult time visiting pharmacy in person. Therefore, this 
proposed rule would not require an in-person request by the patient in 
every case and would allow alternative pathways for the patient to make 
such a request and specify the amount to be filled (e.g., phone call by 
the patient to the pharmacist, or a signed written note from the 
patient and delivered by a family member to the pharmacist).
    However, it should be noted that the CARA only authorizes the 
``patient''--not a member of the patient's household--to make such 
request. Whereas the CSA defines ``ultimate user'' to include a member 
of the patient's household (21 U.S.C. 802(27)), the new section 829(f) 
refers only to ``the patient or the practitioner that wrote the 
prescription'' making the request for the partial fill. Thus, the CARA 
did not authorize members of the patient's household to request the 
partial filling of a prescription on behalf of the patient.

How a Pharmacy Must Record the Partial Filling of a Prescription for a 
Schedule II Controlled Substance When Requested By the Patient

    Under the proposed rule, when partially filling a prescription for 
a schedule II controlled substance at the request of the patient, the 
pharmacist must make the same notation on the prescription as when 
partially filling a prescription at the request of the prescribing 
practitioner. With an electronic prescription, as discussed above in 
the section on pharmacy recording requirements, the notation must be 
linked to an electronic prescription record. Since the prescription 
will not contain the partial fill instructions from the prescriber, the 
pharmacy would also be required under the proposed rule to indicate on 
the prescription that the patient requested the partial fill. For 
uniformity and clarity, DEA is proposing that the pharmacy record on 
all such prescriptions: (1) ``patient requested partial fill on [date 
such request was made],'' and (2) the quantity dispensed. In the event 
the prescribing practitioner already made the request to partially fill 
the prescription t, the pharmacy will not be required to make any 
notation on the prescription indicating that the patient requested a 
partial fill, unless the patient requested a smaller amount. However, 
where a practitioner has requested the partial filling of a 
prescription, the patient may not request a partial filling in an 
amount greater than that specified by the practitioner.

Request for Public Comment

    Parts of this proposed rule merely restate the provisions of the 
CARA setting forth the general requirements

[[Page 78285]]

for partial filling of prescriptions for schedule II controlled 
substances. Since these provisions are mandated by Congress, DEA is 
obligated to incorporate them into the agency regulations. However, 
other parts of the proposed rule would fill in any gaps in the 
regulatory scheme not addressed by Congress. Accordingly, DEA solicits 
public comment on the following provisions of the proposed rule: Sec.  
1306.13(b)(3), (4), and (5).

Regulatory Analysis

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

    This proposed rule was developed in accordance with the principles 
of Executive Orders (E.O.) 12866 and 13563. E.O. 12866 directs agencies 
to assess all costs and benefits of available regulatory alternatives 
and, when regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, public health and 
safety, and environmental advantages; distributive impacts; and 
equity). E.O. 13563 is supplemental to and reaffirms the principles, 
structures, and definitions governing regulatory review as established 
in E.O. 12866. The E.O. classifies a ``significant regulatory action'' 
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, 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 E.O.
    DEA expects that this proposed rule will have an annual effect on 
the economy of $100 million or more in cost savings and therefore is an 
economically significant regulatory action. The analysis of benefits 
and costs is below.
    The economic, interagency, budgetary, legal, and policy 
implications of this proposed rule have been examined and it has been 
determined to be a significant regulatory action under E.O. 12866, and 
therefore has been submitted to the Office of Management and Budget 
(OMB) for review.
I. Need for the Rule
    As discussed above, the CARA was signed into law on July 22, 2016. 
One of the provisions of the CARA amended the CSA to allow for the 
partial filling of prescriptions for schedule II controlled substances 
under certain conditions, providing flexibilities to prescribers and 
patients. Specifically, the CARA amended 21 U.S.C. 829 by adding new 
subsection (f), which allows a pharmacist to partially fill a 
prescription for a schedule II controlled substance where requested by 
the prescribing practitioner or the patient. Subsection (f) further 
provides that for such partial filling to be lawful under the CSA, all 
of the following conditions must be satisfied: (1) The partial filling 
must not be prohibited by State law; (2) the prescription must be 
written and filled in accordance with the CSA, DEA regulations, and 
State law; and (3) the total quantity dispensed in all partial fillings 
must not exceed the total quantity prescribed. In addition, subsection 
(f) provides that the remaining portions of a partially filled 
prescription for a controlled substance in schedule II, if filled, must 
be filled no later than 30 days after the date on which the 
prescription is written, unless the prescription is issued as an 
emergency oral prescription, in which case the remaining portions, if 
filled, must be filled no later than 72 hours after it was issued.
II. Alternative Approaches
    When the prescriber requests the partial fill, the pharmacy's 
actions are straightforward. The pharmacist dispenses the prescription 
according to the prescriber's partial fill instructions and makes the 
required notations on the prescription, and the pharmacy maintains the 
required dispensing records. However, DEA considered three regulatory 
alternatives regarding the required notifications when the partial fill 
is at the request of the patient. DEA considered whether the pharmacist 
should (1) notify the prescribing practitioner or the prescribing 
practitioner's agent of the patient's request to partially fill the 
prescription, and obtain the prescribing practitioner's consent for the 
quantity; (2) notify the prescribing practitioner or the prescribing 
practitioner's agent of the patient's partial fill request, but not 
require the prescribing practitioner's consent; or (3) simply dispense 
the partial fill as requested without any notification or consent. As 
the pharmacist's requirement for notification or consent is the only 
difference between the alternatives, the alternatives analysis below 
only examines the estimated cost of notification or consent. A complete 
discussion of benefits and costs is described in the following section.
Alternative 1: Obtain Prescribing Practitioner's Consent for the 
Partial Fill Quantity Prior to Dispensing
    The first alternative would require the prescribing practitioner's 
consent of the quantity to be dispensed before the pharmacist dispenses 
a partial fill at the patient's request. Upon receiving a patient's 
request for a partial fill, the pharmacist would contact the 
prescribing practitioner or the prescribing practitioner's agent, and 
confirm that the prescribing practitioner concurs with the requested 
partial fill quantity. After confirmation, the pharmacist would 
dispense the partial fill and make the required notation on the 
prescription. The notation includes the method of notification (e.g., 
telephone, email, voicemail) and the person notified.
    DEA estimates obtaining consent would require six minutes from each 
of the parties involved: The pharmacist to request consent, the 
prescribing office to review request and for the prescribing 
practitioner or practitioner's agent to give consent, and the patient 
to wait while consent is received. To estimate the cost, DEA used the 
following labor wage and employment cost rates from the U.S. Department 
of Labor, Bureau of Labor Statistics (BLS). The following occupations' 
median hourly wages were noted: \4\
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    \4\ BLS, May 2018 National Occupational Employment and Wage 
Estimates, United States. https://www.bls.gov/oes/current/oes_nat.htm. (Accessed 2/6/2020.)
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    <bullet> Pharmacist requesting consent: 29-1051 Pharmacists, 
$60.64.
    <bullet> Prescriber's representative to give consent: 43-6033 
Medical Secretaries, $17.19.
    <bullet> Patient: 00-0000 All Occupations, $18.54.
    Additionally, a load of 42.7 percent for benefits was applied to 
the median hourly wages to obtain loaded median hourly wages below: \5\
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    \5\ BLS, ``Employer Costs for Employee Compensation--September 
2019'' (ECEC) reports that average benefits for private industry is 
29.9 percent of total compensation. The 29.9 percent of total 
compensation equates to 42.7 percent (29.9%/70.1%) load on wages and 
salaries.
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    <bullet> Pharmacist requesting consent: 29-1051 Pharmacists, 
$86.53.
    <bullet> Prescriber's representative to give consent: 43-6033 
Medical Secretaries, $24.53.

[[Page 78286]]

    <bullet> Patient: 00-0000 All Occupations, $26.51.
    Therefore, the estimated cost of obtaining consent (six minutes per 
occurrence) would cost the pharmacy $8.65, the prescriber $2.45, and 
the patient $2.65, for a total $13.85 per occurrence.
    While DEA does not have a strong basis to estimate the number of 
instances the patient will request partial filling of a prescription 
for schedule II control substance, in the Cost Savings discussion 
below, the estimated total prescriptions for potential partial filling 
is 36,375,279. DEA used the midpoint between 0 and 100 percent--half 
(18,187,640)--to estimate the cost savings. DEA does not know all the 
reasons a patient may request a partial fill, but believes a patient 
requesting a partial filling of a prescription for a schedule II 
controlled substance may seek a partial fill because: The patient is 
aware of the potential dangers of excess opioids in the household, the 
patient does not want excess opioids in the household, the patient 
believes he or she will not need all the dosages prescribed, and there 
is no additional cost or logistical burden as a result of the partial 
fill. DEA further believes that patients are likely to follow the 
instructions of prescribers, and estimates only a small minority of the 
estimated 18,187,640 requests for partial fills will be at the request 
of the patient. For the purposes of this analysis, DEA assumes 10 
percent, or 1,818,764 partial fills will be at the request of the 
patient. Applying the cost per occurrence to the number of occurrences, 
this alternative is estimated to cost pharmacies approximately $15.7 
million per year for the pharmacists to obtain consent, prescribing 
practitioners approximately $4.5 million per year to give consent, and 
patients $4.8 million while waiting for the pharmacist to obtain 
consent from the prescribing practitioner or practitioner's agent for a 
total $25.0 million per year. The table below summarizes this 
calculation.

                                 Table 1--Summary Calculation for Alternative 1
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                                   Loaded hourly   Time required     Cost per        Number of      Total cost
                                     wage ($)         (hours)     occurrence ($)    occurrences        ($M)
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Pharmacy........................           86.53             0.1            8.65       1,818,764            15.7
Prescriber......................           24.53             0.1            2.45       1,818,764             4.5
Patient.........................           26.51             0.1            2.65       1,818,764             4.8
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    Total.......................             N/A             N/A           13.75             N/A            25.0
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    This alternative was not selected. It is contrary to the plain 
language of the statutory text which allows a patient to request a 
partial fill without obtaining the practitioner's consent. Although 
this alternative ensures consideration of the partial fill by the 
prescribing practitioner, DEA believes this alternative is 
unnecessarily burdensome. While DEA does not have a basis to estimate 
the likelihood of the prescribing practitioner denying consent for 
partial fills, DEA assumes denials would be rare. DEA welcomes public 
comments regarding this assumption. The patient may request a partial 
fill for a variety of reasons, and a partial fill request does not 
necessarily mean that the remaining portions of the prescription will 
not be filled. While making the prescribing practitioner aware of the 
partial fill would be helpful, requiring consent prior to the 
pharmacist's dispensing the partial fill would be unnecessarily 
burdensome, and, thus, this alternative was not selected.
Alternative 2: Notify the Prescribing Practitioner of the Partial Fill 
Quantity After Dispensing
    The second alternative would require notification to the 
prescribing practitioner or the prescribing practitioner's agent of the 
quantity dispensed upon the patient's request for the partial fill. In 
this scenario, the prescribing practitioner's consent for the partial 
fill would not be required. Instead, the pharmacist would partially 
fill the prescription based on the patient's request, notify the 
prescribing practitioner or the prescribing practitioner's agent of the 
quantity dispensed, and make the required notation on the prescription. 
The notation is the same method as for alternative 1.
    DEA estimates notifying the prescribing practitioner will require 
three minutes from each of the parties involved: The pharmacist to 
contact the prescribing office to give notice and the prescribing 
office to receive and review notice. Using the same BLS occupations and 
loaded median hourly wages as Alternative 1, the estimated cost of each 
notification (three minutes per occurrence) would cost the pharmacy 
$4.33 and the prescriber $1.23 for a total $5.56 per occurrence.
    Applying the same estimate of 1,818,764 partial fills, as in 
Alternative 1, this alternative is estimated to cost pharmacies 
approximately $7.9 million per year for the pharmacists to give notice 
and prescribing practitioners approximately $2.2 million per year to 
receive and review notice. The table below summarizes this calculation.

                                 Table 2--Summary Calculation for Alternative 2
----------------------------------------------------------------------------------------------------------------
                                   Loaded hourly   Time required     Cost per        Number of      Total cost
                                     wage ($)         (hours)     occurrence ($)    occurrences        ($M)
----------------------------------------------------------------------------------------------------------------
Pharmacy........................           86.53            0.05            4.33       1,818,764             7.9
Prescriber......................           24.53            0.05            1.23       1,818,764             2.2
                                 -------------------------------------------------------------------------------
    Total.......................             N/A             N/A            5.56             N/A            10.1
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[[Page 78287]]

    This alternative was not selected. DEA believes that this 
alternative is also unnecessarily burdensome. Although this alternative 
would ensure that the prescribing practitioner is made aware of the 
partial filling of the prescription and could react to this information 
if needed. However, it would cause an additional compliance-burden on 
both the pharmacy and prescribing practitioner.
Alternative 3: Dispense Partial Fill as Requested Without Consent of, 
or Notification to, the Prescribing Practitioner
    The third alternative would not require the consent of, or 
notification to, the prescribing practitioner described in alternative 
1 or 2, respectively. In this alternative, the pharmacist would 
partially fill the prescription based on the patient's request and make 
the required notation on the prescription. This alternative results in 
no notification-related cost to the pharmacy or prescriber.
    This alternative was selected. Although a partial fill at the 
request of the patient may represent a departure from the prescribing 
practitioner's dispensing instructions, this alternative is the least 
burdensome to the pharmacy, prescribing practitioner, and the patient. 
Additionally, a partial fill does not preclude the eventual dispensing 
of the full amount prescribed. Under the proposed rule, patients 
requesting a partial fill would be entitled to request that the 
pharmacist fill the remainder of the prescription within a 30-day 
window. This alternative would result in no additional consent or 
notification-related costs and would not impose dispensing delays on 
patients requesting a partial fill. A further discussion of the 
benefits and costs of this alternative is described below.
III. Analysis of Benefits and Costs
    The proposed rule would allow partial fills of controlled 
substances in schedule II at the request of the patient or the 
prescribing practitioner, if not prohibited by State law. The proposed 
rule also includes time limitations on filling the remaining portions 
of a partially filled prescription for a schedule II controlled 
substance, and additional provisions for how a practitioner may request 
that a prescription for a schedule II controlled substance be partially 
filled, and how a pharmacy must record the partial filling of a 
prescription for a schedule II controlled substance.
    DEA examined the benefits, costs, and cost savings associated with 
this proposed rule.
Benefits
    DEA does not know all the reasons a prescriber or patient might 
request a partial fill of a prescription. However, as discussed in the 
Cost Savings section below, a significant portion of filled opioid 
prescriptions go unused, leading to the excess opioids being kept by 
the patient that could be for improper use, diversion, abuse, or 
improper disposal. Partial filling is expected to reduce the quantity 
of unused schedule II controlled substances, which would decrease the 
risk of diversion, and the danger that patients or others may become 
dependent upon or addicted to prescribed scheduled II controlled 
substances.
    The supply of unused drugs in U.S. households contributes to demand 
for opioids and illicit drug use. Keeping and storing unused 
medications in households poses several dangers related to misuse, 
diversion, accidental overdose, and consumption of spoiled 
substances.\6\ Many patients receive their first opioid prescription 
after a surgical procedure and frequently retain the majority of unused 
medication, which could potentially be sold illegally or misused by the 
patient. In addition, unused medication can be diverted and used by 
other members of the patient's household, friends of the patient, or 
sold. According to the National Institute on Drug Abuse, 21 to 29 
percent of patients prescribed opioids for chronic pain misuse them, 
between 8 and 12 percent prescribed opioids for chronic pain develop an 
opioid use disorder, an estimated 4 to 6 percent who misuse 
prescription opioids transition to heroin, and about 80 percent of 
people who use heroin first misused prescription opioids.\7\ According 
to one journal article, ``multiple studies have reported an increased 
risk of new persistent opioid use after prescription of opioids for 
acute pain in opioid na[iuml]ve patients. Even patients who undergo 
relatively minor low-pain surgery are at increased risk of long term 
opioid use.'' \8\ According to the Substance Abuse and Mental Health 
Administration (SAMHSA), 51.3 percent of people ``who misused pain 
relievers in the past year obtained the last pain reliever they misused 
from a friend or relative.'' \9\ Also, although opioid medications are 
effective in managing acute pain after surgery, even short-term use of 
opioids can lead to long-term dependence.\10\
---------------------------------------------------------------------------

    \6\ ``Safe Disposal of Unused Controlled Substances: Current 
Challenges and Opportunities for Reform,'' Avalere, http://www.ncdoi.com/osfm/safekids/documents/omd/safedisposalofunusedcontrolledsubstancesreport.pdf.
    \7\ ``Opioid Overdose Crisis,'' National Institute on Drug 
Abuse, https://www.drugabuse.gov/drugs-abuse/opioids/opioid-overdose-crisis. (Accessed 2/12/2020.)
    \8\ ``Prescription of opioids for acute pain in opioid 
na[iuml]ve patients,'' 2019, Carlos A Pino, MD, Melissa Covington, 
MD, Uptodate.com, Wolters Kluwer. https://www.uptodate.com/contents/prescription-of-opioids-for-acute-pain-in-opioid-naive-patients.
    \9\ ``Key Substance Use and Mental Health Indicators in the 
United States: Results from the 2018 National Survey on Drug Use and 
Health,'' SAMHSA, https://www.samhsa.gov/data/report/2018-nsduh-annual-national-report.
    \10\ Empowering Post-Surgical Patients to Improve Opioid 
Disposal: A Before and After Quality Improvement Study Jessica M. 
Hasak, Carrie L. Roth Bettlach, Katherine B. Santosa, Ellen L. 
Larson, Jean Stroud, Susan E. Mackinnon Journal of the American 
College of Surgeons 2017.
---------------------------------------------------------------------------

    The total U.S. economic burden (healthcare costs, criminal justice 
costs, and lost productivity costs) of prescription opioid misuse in 
2013 was estimated to be $78.5 billion, based on the 1.935 million 
Americans estimated to meet the American Psychiatric Association's 
Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria 
for opioid use disorder.\11\ This economic burden equates to 
approximately $41,600 per person with opioid use disorder.\12\ DEA 
estimates approximately $41,600 in societal benefit accrues each time 
we prevent an individual from developing opioid use disorder. This 
proposed rule is expected to lower the prevalence of opioid misuse and 
thereby reduce rates of opioid addiction. While DEA has no basis to 
quantify the amount of misuse that will be prevented, DEA anticipates 
that reductions in opioid dispensing will reduce the amount of unused 
opioid medications in American homes, thereby reducing opportunities 
for medication sharing and other forms of diversion. This, in turn will 
have a real and significant benefit by reducing misuse and development 
of opioid use disorder.
---------------------------------------------------------------------------

    \11\ Florence CS, Zhou C, Luo F & Xu L, The Economic Burden of 
Prescription Opioid Overdose, Abuse, and Dependence in the United 
States, 2013, 54 Med Care 901 (2016). DEA's 2017 National Drug 
Threat Assessment also references this estimate for total economic 
burden of prescription drug abuse.
    \12\ $78.5 billion/1.935 million patients = $40,568 per patient.
---------------------------------------------------------------------------

Cost Savings
    This proposed rule is estimated to lower the amount of schedule II 
medications dispensed and, therefore, expenditures on prescriptions. It 
is also expected to reduce the number of unused schedule II controlled 
substances requiring disposal. To

[[Page 78288]]

quantify the cost savings, DEA estimated the cost of excess medicine 
and calculated the approximate percent cost savings opportunity that 
may be realized by this proposed rule.
    In 2017, 163,683,029 schedule II prescriptions were filled for 
``acute'' pain, with a total retail cost of $11,807,297,373, or an 
average retail cost of $72.14 per prescription.\13\ The prescription 
data includes a data field that indicates whether the condition being 
treated is ``acute'' or ``chronic.'' The figure excludes schedule II 
controlled substances generally prescribed for chronic conditions, 
i.e., amphetamine, lisdexamfetamine, methamphetamine, and 
methylphenidate. DEA believes prescriptions for ``acute'' conditions 
are more likely to be partially filled. Therefore, DEA estimates 
163,683,029 prescriptions represent the total number of prescriptions 
that may be partially filled per year. However, many States have 
already passed laws or adopted regulations limiting the quantity of 
schedule II controlled substances that may be dispensed pursuant to a 
prescription. For example, in 2016, Massachusetts became the first 
state to pass a law to limit first time opioid prescriptions to seven 
days.\14\ Since 2016, many other States have passed similar laws 
limiting the prescribing of opioids for acute pain. These limits 
generally range from a 3 to 14-day supply.\15\ As of September 2019, 36 
States have placed limits on the amount of opioids that can be 
prescribed by doctors.\16\ The limits in five of those States apply 
only to Medicaid recipients, and two States have no pill or day limits, 
but require doctors to prescribe the lowest effective dose.\17\ Based 
on review of state limits for prescribing of opioids, DEA estimates 
there are 34 states with pill or day limits in place, representing 68.7 
percent of the U.S. population.\18\ DEA believes partial fill 
provisions under this proposed rule are likely to have impact on the 
remaining states without opioid prescription limits, representing 31.3 
percent of the U.S. population. Applying this percentage, DEA estimates 
51,232,788 (31.3 percent) of the 163,683,029 total prescriptions may be 
partially filled. According to a 2017 study of post-surgical patients 
who were prescribed opioids, only 29 percent used the entire 
prescription, leaving 71 percent of post-surgical patients with excess 
opioids.\19\ The study found that patients prescribed opioids after 
surgery consumed, on average, only 33 percent of the prescribed 
medication.\20\ Based on that finding, DEA estimates 71 percent of 
patients will not use all controlled substance prescriptions. DEA 
therefore estimates that 36,375,279 (71 percent) of the estimated 
51,232,788 prescriptions in states without controlled substance 
prescribing or dispensing limits will not be fully utilized, presenting 
an opportunity for cost savings from partial fills.
---------------------------------------------------------------------------

    \13\ IQVIA Data 2017. Prescriptions for ``acute pain'' were used 
to differentiate from ``chronic'' conditions, which are limited to 
prescriptions for amphetamine. $11,807,297,373/163,683,029 = $72.14.
    \14\ ``Opioid Prescribing Limits Across the States,'' Marilyn 
Bullock, PharmD, BCPS, FCCM, 2/5/2019, pharmacytimes.com.
    \15\ Ibid.
    \16\ ``Opioid prescription limits and policies by state.'' 
https://ballotpedia.org/Opioid_prescription_limits_and_policies_by_state. (Accessed 2/3/
2020.)
    \17\ Ibid.
    \18\ For the purposes of this discussion, ``State'' includes 
Puerto Rico and the District of Columbia. Population estimates are 
based on the U.S. Census Bureau's 2019 population estimates. The 34 
States that have pill or day limits are: Alaska, Arizona, Colorado, 
Connecticut, Delaware, Florida, Hawaii, Indiana, Iowa, Kentucky, 
Louisiana, Maine, Massachusetts, Michigan, Minnesota, Missouri, 
Nebraska, Nevada, New Hampshire, New Jersey, New York, North 
Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, South 
Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, 
West Virginia.
    \19\ Empowering Post-Surgical Patients to Improve Opioid 
Disposal: A Before and After Quality Improvement Study Jessica M. 
Hasak, Carrie L. Roth Bettlach, Katherine B. Santosa, Ellen L. 
Larson, Jean Stroud, Susan E. Mackinnon Journal of the American 
College of Surgeons 2017. The purpose of the study was to determine 
whether providing an educational brochure would improve disposal 
methods of excess opioids. The study found 35 of 128 participants 
not given the educational brochure used the entire prescription, and 
40 of 130 participants given the educational brochure used the 
entire prescription. Combining the two groups, 75 (29%) of 258 
participants used the entire prescription.
    \20\ Ibid.
---------------------------------------------------------------------------

    Assuming a typical partial fill request is for 50 percent of the 
prescription, and as discussed above, a patient is not likely to return 
to fill the remaining portion of the prescription, the estimated 
savings from the remaining unfilled portions is 50 percent of the 
average cost per prescription ($72.14) or $36.07. Multiplying the 
estimated savings per prescription of $36.07 by the number of 
prescriptions available for cost savings (36,375,279) results in 
$1,312,035,331 in potential cost savings per year. However, DEA does 
not have a basis to estimate the actual number or percentage of 
controlled substances issued in these states that will be partially 
filled, and therefore cannot estimate likely aggregate savings based on 
this methodology. For the purposes of this analysis, DEA estimates 50 
percent of potential savings, or $656,028,165 (representing 18,187,640 
partially filled prescriptions) will be realized as annual cost savings 
from reduced schedule II controlled substance dispensing. DEA does not 
have a basis to estimate the impact of this proposed rule on payments 
to pharmacies, in terms of price per dosage units, copays, insurance 
reimbursements, etc., or who would realize the cost savings.
    In addition to the cost savings from not dispensing remaining 
portions of partially filled prescriptions, DEA anticipates cost 
savings from the reduced need to dispose of unused medications. 
Patients dispose of unused drugs in a variety of ways, including 
throwing them in the trash, flushing them down the toilet, pouring them 
down the sink drain, taking them to the pharmacy or physician's office, 
or taking them to a drug take back site or event. In a two-phased study 
using a convenience sample in Southern California, researchers found 
that only 13 percent of people surveyed either disposed of their 
medications by taking them to the pharmacy or to the physician's 
office.\21\ For the purpose of this analysis, DEA assumes that only 13 
percent of people with leftover schedule II medications dispose of 
their unused medications in this way. It is likewise estimated that 
two-thirds of dispensed medications in the United States are unused by 
patients.\22\ Based on DEA's assumption that a typical partial fill 
represents 50 percent of the prescription, and that the average 
partially filled prescription represents 67 pills, DEA estimates the 
average number of excess pills is 34 (50% x 67 pills) per full 
prescription filled.\23\ To calculate the total cost savings for 
patients not needing to dispose of their unused schedule II drugs, DEA 
first multiplied the estimated number of partial fill prescriptions by 
the average disposal pill count to get a total of 618,379,760 pills 
(18,187,640 x 34). To estimate the number of pills being disposed of by 
patients through pharmacies, physician offices, or take back days, DEA 
multiplied the total number of pills (618,679,760) by 13 percent to get 
80,389,369 pills. Using the average cost per disposal of $5.60/pound 
collected,\24\ and the estimate of

[[Page 78289]]

pound/pill of .0069,\25\ the total cost savings for unused pills not 
needing to be disposed of is $3,106,245 (80,389,369 x $5.60 x .0069). 
The remaining 87 percent of pills that are not properly disposed of are 
assumed to be either thrown away in the trash (62.7 percent), flushed 
down the toilet (18 percent), disposed of in the sink (4.3 percent), 
not disposed of and stored (17.4 percent), and other (8 percent).\26\ 
Therefore, the total annual cost savings of this proposed rule is 
$659,134,410 ($656,028,165 + $3,106,245).
---------------------------------------------------------------------------

    \21\ ``Taking Stock of Medication Wastage: Unused Medications in 
US Households.'' NeuroImage, Academic Press, 16 Oct. 2014, 
www.sciencedirect.com/science/article/pii/S1551741114003337?via%3Dihub.
    \22\ Ibid.
    \23\ IMS Health IQVIA Data 2017. The 67 average number of pills 
dispensed was determined by dividing the total number of 
prescriptions in 2017 by the total number of extended units 
(10,921,740,149/163,683,029).
    \24\ Siler, S., Duda, S., Brown, R., Gbemudu, J., Weiner, S., & 
Glaudemans, J. (n.d.). Safe Disposal of Unused Controlled 
Substances. Retrieved September 21, 2018, from http://www.ncdoi.com/osfm/safekids/documents/omd/safedisposalofunusedcontrolledsubstancesreport.pdf.
    \25\ http://michigan-open.org/statewide-drug-takeback-event-nets-900-pounds-of-opioids-more///.
    \26\ ``Taking Stock of Medication Wastage: Unused Medications in 
US Households.'' NeuroImage, Academic Press, 16 Oct. 2014, 
www.sciencedirect.com/science/article/pii/S1551741114003337?via%3Dihub. Percentages are of improper disposal 
methods only. There were other choices on the survey: Take it to the 
pharmacy (11.2 percent) and take it to the physician's office (1.8 
percent), The percentages do not add to 100 percent because 
respondents were allow to select more than one method.
---------------------------------------------------------------------------

Costs
    DEA estimates there is a cost to prescribers associated with the 
time burden of writing instructions for partial fill prescriptions.
    Partial filling of a prescription for a schedule II controlled 
substance, pursuant to this proposed rule, may be requested by the 
prescriber or the patient. The prescriber may request a partial fill by 
specifying the quantity to be dispensed in the partial filling on the 
face of the written prescription, in the written record of the 
emergency oral prescription, or in the electronic prescription record, 
along with other information required in 21 CFR 1306.05. While any 
additional time to specify the quantity to be dispensed in the partial 
filling may be minimal, especially when viewed in relation to the 
entire duration of the medical interaction between the prescriber and 
the patient, DEA estimates each partial fill requested by the 
prescriber will require 10 additional seconds for the prescriber to 
specify the quantity to be dispensed. Based on BLS' mean hourly wage 
for ``29-1060 Physicians and Surgeons'' of $101.43 and a 42.7 percent 
load for benefits, the estimated loaded hourly wage for a prescriber is 
$144.74.\27\ Therefore, the 10 additional seconds to specify the 
quantity to be dispensed equates to $0.40.\28\ As discussed in the Cost 
Savings discussion above, DEA does not have a basis to estimate the 
percentage of the estimated 36,375,279 prescriptions per year available 
for partial filling that would be partially filled pursuant to this 
proposed rule. Therefore, for the purposes of this analysis, DEA 
estimates the mid-point (50 percent), or 18,187,640 prescriptions per 
year, will be partially filled at the request of the prescriber at an 
annual cost of $7,275,056.
---------------------------------------------------------------------------

    \27\ BLS, May 2018 National Occupational Employment and Wage 
Estimates, United States. https://www.bls.gov/oes/current/oes_nat.htm. (Accessed 2/6/2020.) BLS, ``Employer Costs for Employee 
Compensation--September 2019'' (ECEC) reports that average benefits 
for private industry is 29.9 percent of total compensation. The 29.9 
percent of total compensation equates to 42.7 percent (29.9%/70.1%) 
load on wages and salaries. $101.43 x 1.427 = $144.74. The 
``median'' hourly rate is generally preferred. However, the median 
hourly rate for this occupation code was not available; thus, the 
``mean'' was used. While it is likely some of the partial fill 
instructions will be written by a mid-level practitioner, i.e., 
nurse practitioner, physician's assistant, etc., or a nurse (in 
preparation for the prescriber's signature), DEA believes this 
loaded hourly rate is a reasonably conservative estimate.
    \28\ 10 seconds x (1 hour / 3,600 seconds) x $144.74/hour = 
$0.40.
---------------------------------------------------------------------------

    When a prescribing practitioner has properly specified his or her 
intent to partially fill a prescription for a schedule II controlled 
substance, the proposed rule would require the pharmacist to record the 
partial filling in a manner similar to that required under the existing 
regulations for other circumstances.\29\ Specifically, the dispensing 
pharmacist would need to make a notation of the quantity dispensed on 
the face of the written prescription, in the written record of the 
emergency oral prescription, or in the electronic prescription record 
(as is currently required under 21 CFR 1306.13(a) when the pharmacist 
is unable to supply the full quantity called for in the schedule II 
prescription). Also, for each such partial filling, the pharmacy would 
be required to maintain a record with the date of each dispensing, the 
name or initials of the individual who dispensed the substance, and all 
other information required by 21 CFR 1306.22(c) for schedule III and IV 
prescription refills. DEA believes the most common scenario would be 
that the partial fill information is entered into a computerized 
system, in an existing data field; then, an adhesive label with 
relevant information would be printed, and subsequently affixed to the 
prescription container. When partially filling a prescription for a 
schedule II controlled substance at the patient's request, the 
pharmacist would need to make the same notation on the prescription as 
when partially filling a prescription at the request of the prescribing 
practitioner, along with additional information indicating that the 
patient requested the partial fill. While DEA believes documenting the 
quantities dispensed for each filled prescription is a usual and 
ordinary activity for a pharmacist, DEA estimates that it may require 
10 additional seconds for a pharmacist to record a partial fill, 
pursuant to this proposed rule. Based on an estimated loaded median 
hourly rate of $86.53 for a pharmacist, from the alternatives analysis 
above, the 10 additional seconds to record partial fills equates to 
$0.24.\30\ As discussed above, DEA does not have a basis to estimate 
the percentage of the estimated 36,375,279 prescriptions per year that 
would be partially filled. Therefore, for the purposes of this 
analysis, DEA estimates the mid-point (50 percent), or 18,187,640 
prescriptions per year will be partially filled, requiring recording of 
the partial fill by the pharmacist at an annual cost of $4,365,034.
---------------------------------------------------------------------------

    \29\ See note 2.
    \30\ 10 seconds x (1 hour / 3,600 seconds) x $86.53/hour = 
$0.24.
---------------------------------------------------------------------------

    If a patient received a partial fill pursuant to this proposed 
rule, and then returns to the pharmacy to receive another partial fill, 
or the remainder of the initial prescription, the pharmacist would 
require some additional time to fill the prescription. For example, if 
filling the remainder of the partial fill required 10 additional 
minutes, based on the estimated loaded median hourly rate of $86.53 for 
a pharmacist, that additional time would equate to a cost of $14.42. 
Additionally, there would be a similar cost to the patient to 
potentially make an additional trip to the pharmacy and waiting for the 
prescription to be filled. However, DEA estimates these additional 
interactions will be minimal. As discussed earlier in reference to the 
2017 study of post-surgical patients who were prescribed opioids, 71 
percent of patients in the study did not use the entire prescription, 
and on average the patients only used 33 percent of the prescribed 
opioids. If prescribers and patients randomly asked for partial fills, 
only a small minority of patients would return for the remainder of the 
prescription. However, DEA does not anticipate the request for partial 
fills, at the request of the prescriber or the patient, to be random. 
Rather, DEA anticipates prescribers will exercise professional judgment 
and foresight in determining when a partial fill is best suited. DEA 
does not believe a partial fill will be requested by the prescriber 
when the prescriber believes the patient is likely to need all of the 
prescribed

[[Page 78290]]

medicine. Furthermore, while the proposed rule would permit patients to 
request partial fills, DEA believes patients are unlikely to request a 
partial fill. Rather, the patient would follow the prescriber's 
instruction, based on consultation between the prescriber and the 
patient. Therefore, DEA believes any increase in the number of patient-
pharmacy interactions related to patient-requested partial fills and 
resulting burden would likely be de minimis. DEA estimates the total 
cost of this proposed rule is $11,640,090 ($7,275,056 to prescribers 
and $4,365,034 to pharmacies) per year.
Discussion of Uncertainties
    This analysis evaluates the economic impact of activities that were 
previously not permitted. Therefore, DEA does not have a strong basis 
to estimate the level of participation in these activities, including 
partial filling of prescriptions for schedule II controlled substances 
by prescribers and patients, and how insurance companies would react to 
these partial filling of prescriptions.
    This analysis is highly sensitive to the percentage of 
prescriptions being partially filled, and the percentage of partially 
filled prescriptions with patients returning for remainder of the 
partially filled prescription.
    For example, if prescribers and patients in States with no opioid 
prescription pill or day limits requested a partial fill of 50 percent 
of the prescription amount for all 71 percent of prescriptions where 
not all drugs are used, the estimated cost savings from not dispensing 
the full prescriptions increases to $1,312,035,331 (representing 
36,375,279 partially filled prescriptions). Because DEA does not have a 
good basis to estimate the potential cost savings that will be 
realized, for the purposes of this analysis, DEA estimates the mid-
point (50 percent), or $656,028,165 (representing 18,187,640 partially 
filled prescriptions) will be realized as cost savings from not 
dispensing excess schedule II controlled substances. An estimate of 
zero percent would result in zero cost savings. As the percentage of 
cases where partial fills are requested increases, the estimated cost 
savings increase proportionally.
    DEA anticipates prescribers will exercise professional judgment and 
foresight in determining when a partial fill is best suited. DEA does 
not believe a partial fill will be requested by the prescriber when the 
prescriber believes the patient is likely to need all of the prescribed 
medicine, resulting in a minimal number of patients returning for the 
remainder of the partially filled prescription. Furthermore, while the 
proposed rule would permit patients to request partial fills, DEA 
believes of patients are unlikely to request a partial fill. Rather, 
the patient would follow the prescriber's instruction, based on 
consultation between the prescriber and the patient.
    Finally, this analysis excluded any anticipated impact of this 
proposed rule on payments to pharmacies, in terms of price per dosage 
units, copays, insurance reimbursements, etc., or who would realize the 
cost savings.
    DEA welcomes all comments that would narrow the uncertainties in 
the presented analysis, and specifically asks prescribers, patients, 
and health care industry, including insurance companies, the following 
questions:
    1. Why do so many prescriptions for schedule II controlled 
substances result in unused dosages?
    2. Would prescribers start using this proposed regulatory provision 
and start giving instructions for partial filling of schedule II 
controlled substances, or are there other factors that are likely not 
to result in prescribers giving partial filling instructions?
    3. How often would a prescriber instruct partial filling of a 
prescription for a schedule II controlled substance?
    4. Is it reasonable to anticipate a prescriber will exercise 
professional judgment and foresight in determining when partial fill 
would most appropriate, resulting in minimal number of patients 
returning for the remainder of the partially filled prescription or 
experiencing pain because they run out of medication? Would prescribers 
be likely to use consistent criteria for determining when to give 
partial refills? Given that the majority of schedule II prescriptions 
are not fully utilized, should prescribers request partial fills in 
most cases?
    5. How likely are patients to request partial filling at the 
pharmacy when the prescriber has not given instructions for a partial 
fill on the prescription?
    6. Is it reasonable to assume that a patient interested in a 
partial filling of a schedule II controlled substance would request the 
prescriber to provide instructions on the prescription?
    7. Is it reasonable to assume that when prescribers do not request 
a partial fill patients will generally not request a partial fill?
    8. (Questions for industry including private and public plans and 
entitlements)
    a. What are likely requirements for copay in a partial filling?
    b. Would the copay be reduced?
    c. Would there be a copay when a patient returns for filling the 
remainder of a partially filled prescription (full amount or reduced 
amount)?
    d. Would a patient likely spend less on a partial fill than on a 
full prescription?
    e. If so, would requesting two or more partial fills likely cost 
the patient more than filling the full prescription initially?
Summary
    In summary, DEA estimates that the total cost savings of this 
proposed rule will be $659 million per year, and the total cost will be 
$12 million per year, for a net cost savings of $647 million per year 
(rounded to the nearest million dollars). At a three percent discount 
rate, the net present value of the cost savings over a 5-year period is 
$2,965 million. At a seven percent discount rate, the present value of 
the cost savings is $2,655 million. Due to the fluid nature of the 
national opioid crisis and legislative activity in State government, 
DEA believes using a five-year term for the present value analysis is 
reasonable. DEA welcomes public comment on the assumptions made in this 
analysis.
    This proposed rule is expected to be an E.O. 13771 deregulatory 
action. The proposed rule is an enabling rulemaking, which expands the 
options for filling schedule II prescriptions. OMB's guidance on E.O. 
13771 explains that agencies may carry E.O. 13771 deregulatory actions 
forward to be applied to E.O. 13771 regulatory actions, and to offset 
incremental regulatory costs in the same or subsequent fiscal 
years.\31\ Adjusting from 2017 to 2016 dollars, the estimated annual 
cost savings is $636 million per year over five years, net present 
value of $2,911 million (cost savings) at three percent discount rate, 
and $2,606 million (cost savings) at seven percent discount rate to 
offset future incremental regulatory costs.
---------------------------------------------------------------------------

    \31\ OMB Memorandum M-17-21 at 12.
---------------------------------------------------------------------------

Executive Order 12988, Civil Justice Reform

    This proposed rule meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 12988, to eliminate 
drafting errors and ambiguity, minimize litigation, provide a clear 
legal standard of affected conduct, and promote simplification and 
burden reduction.

Executive Order 13132, Federalism

    This proposed rulemaking does not have federalism implications 
warranting the application of Executive Order 13132. The proposed rule 
does not have

[[Page 78291]]

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 proposed rule does not have tribal implications warranting the 
application of Executive Order 13175. It does not have substantial 
direct effects on one or more Indian tribes, or on the distribution of 
power and responsibilities between the Federal Government and Indian 
tribes.

Regulatory Flexibility Act

    The Acting Administrator, in accordance with the Regulatory 
Flexibility Act, 5 U.S.C. 601-602, has reviewed this proposed rule and 
by approving it, certifies that it will not, if promulgated, have a 
significant economic impact on a substantial number of small entities.
    This proposed rule includes provisions regarding partial fill of 
prescriptions for schedule II controlled substances. The proposed rule 
would allow partial fills of prescriptions for controlled substances in 
schedule II at the request of the patient or the prescribing 
practitioner, if not prohibited by State law. The proposed rule also 
includes time limitations on filling the remaining portions of a 
partially filled prescription for a schedule II controlled substance 
and additional provisions for how a practitioner may request that a 
prescription for a schedule II controlled substance be partially 
filled, how a patient may request that a prescription for a schedule II 
controlled substance be partially filled, and how a pharmacy must 
record the partial filling of a prescription for a schedule II 
controlled substance. While not all practitioners may write 
prescriptions with partial fill instructions, and not all pharmacies 
may receive prescriptions for partial fill, these registrants (or 
entities that employ these registrants) would still be subject to the 
partial fill provisions contained in the proposed rule.
    This proposed rule primarily affects prescribers of schedule II 
controlled substances and the pharmacies that fill those prescriptions. 
While prescribers are generally individual practitioners, for the 
purposes of this analysis, DEA includes industries that employ 
prescribers. In Table 3, DEA estimates the industries that would be 
affected by this proposed rule, as described by the North American 
Industry Classification System (NAICS). This list is not intended to 
include an exhaustive list of all employers of prescribers of schedule 
II controlled substances, but rather a representation of primary 
industries that employ them.

           Table 3--Affected Industries, Six-Digit NAICS Code
------------------------------------------------------------------------
  NAICS                          NAICS description
------------------------------------------------------------------------
  446110   Pharmacies and Drug Stores.
  621111   Offices of Physicians (except Mental Health Specialists).
  621210   Offices of Dentists.
  621491   HMO Medical Centers.
  621493   Freestanding Ambulatory Surgical and Emergency Centers.
  622110   General Medical and Surgical Hospitals.
------------------------------------------------------------------------

    The U.S. Census Bureau's Statistics of U.S. Businesses (SUSB) 
publishes the number of firms, employment, and revenue by firm size and 
industry. To estimate the number of small businesses affected, DEA 
compared the 2012 SUSB data, the most recent data available containing 
revenue by firm size and industry,\32\ to the U.S. Small Business 
Administration (SBA) size standards.\33\ DEA estimates a total 326,033 
entities, of which 318,362 are small entities, would be affected by 
this proposed rule. Table 4 details the number of entities, SBA size 
standard, and estimated number of small entities for each affected 
industry.\34\
---------------------------------------------------------------------------

    \32\ ``Number of small businesses: Small entity counts, 
employment, and revenues . . . number of small entities when the 
size standard is based on revenue [Link to: https://www2.census.gov/programs-surveys/susb/tables/2012/us_6digitnaics_r_2012.xlsx].'' 
https://advocacy.sba.gov/resources/the-regulatory-flexibility-act/rfa-data-resources-for-federal-agencies. (Accessed 2/4/2020.)
    \33\ U.S. Small Business Administration, Table of Small Business 
Size Standards Matched to North American Industry Classification 
System Codes, Effective August 19, 2019. https://www.sba.gov/document/support--table-size-standards. (Accessed 2/4/2020.)
    \34\ For the purposes of this analysis, ``firms'' and 
``entities'' are used synonymously.

                              Table 4--Estimated Number of Affected Small Entities
----------------------------------------------------------------------------------------------------------------
                                                                                     SBA size
                                                                                     standard,
           NAICS                      NAICS description                Firms      annual revenue  Small entities
                                                                                       ($M)
----------------------------------------------------------------------------------------------------------------
446110.....................  Pharmacies and Drug Stores.........          18,852            30.0          18,503
621111.....................  Offices of Physicians (except               174,901            12.0         170,287
                              Mental Health Specialists).
621210.....................  Offices of Dentists................         125,151             8.0         124,689
621491.....................  HMO Medical Centers................             104            35.0              81
621493.....................  Freestanding Ambulatory Surgical              4,121            16.5           3,603
                              and Emergency Centers.
622110.....................  General Medical and Surgical                  2,904            41.5           1,199
                              Hospitals.
                                                                 -----------------------------------------------
    Total..................  ...................................         326,033             N/A         318,362
----------------------------------------------------------------------------------------------------------------

    Partial filling of a prescription for a schedule II controlled 
substance, pursuant to this proposed rule, may be requested by the 
prescriber or the patient. The prescriber may request a partial fill by 
specifying the quantity to be dispensed in the partial filling on the 
face of the written prescription, written record of the emergency oral 
prescription, or in the electronic prescription record, along with 
other information required in 21 CFR 1306.05. While any additional time 
to specify the quantity to be dispensed in the partial filling may be 
minimal, especially when viewed in relation to the entire duration of 
the medical interaction between the prescriber and the patient, DEA 
estimates each partial fill requested by the prescriber will require 10 
additional seconds for the prescriber to specify the quantity to be 
dispensed. As discussed in the Costs section above, based on BLS' mean 
hourly wage for ``29-1060 Physicians and Surgeons'' of $101.43 and a 
42.7 percent load for benefits, the estimated loaded hourly wage for a 
prescriber is $144.74. Therefore, the 10 additional seconds to specify 
the quantity to be dispensed equates to

[[Page 78292]]

$0.40.\35\ As discussed in the Cost Savings discussion above, DEA does 
not have a basis to estimate the percentage of the estimated 36,375,279 
prescriptions per year available for partial filling that would be 
partially filled pursuant to this proposed rule. Therefore, for the 
purposes of this analysis, DEA estimates the mid-point (50 percent), or 
18,187,640 prescriptions per year will be partially filled at the 
request of the prescriber at a cost of $7,275,056. This cost of 
$7,275,056 equates to an average of $24 per firm, excluding 
pharmacies.\36\
---------------------------------------------------------------------------

    \35\ 10 seconds x (1 hour / 3,600 seconds) x ($101.43/hour x 
1.427) = $0.40.
    \36\ 326,033 total affected firms - 18,852 pharmacies and drug 
stores = 307,181 firms that employ prescribers. $7,275,056 / 307,181 
= $24 (rounded to nearest whole dollar).
---------------------------------------------------------------------------

    When a prescribing practitioner has properly specified his or her 
intent to partially fill a prescription for a schedule II controlled 
substance, the proposed rule would require the pharmacist to record the 
partial filling in a manner similar to that required under the existing 
regulations for other circumstances.\37\ Specifically, the dispensing 
pharmacist would need to make a notation of the quantity dispensed on 
the face of the written prescription, in the written record of the 
emergency oral prescription, or in the electronic prescription record 
(as is currently required under 21 CFR 1306.13(a) when the pharmacist 
is unable to supply the full quantity called for in the schedule II 
prescription). Also, for each such partial filling, the pharmacy would 
be required to maintain a record with the date of each dispensing, the 
name or initials of the individual who dispensed the substance, and all 
other information required by 21 CFR 1306.22(c) for schedule III and IV 
prescription refills. DEA believes the most common scenario would be 
that the partial fill information is entered into a computerized 
system, in an existing data field; then, an adhesive label with 
relevant information would be printed, and subsequently affixed to the 
prescription container. When partially filling a prescription for a 
schedule II controlled substance at the patient's request, the 
pharmacist would need to make the same notation on the prescription as 
when partially filling a prescription at the request of the prescribing 
practitioner, along with additional information indicating that the 
patient requested the partial fill. While DEA believes documenting the 
quantities dispensed for each filled prescription is a usual and 
ordinary activity for a pharmacist, DEA estimates that it may require 
10 additional seconds for the pharmacist to record a partial fill, 
pursuant to this proposed rule. Based on an estimated loaded median 
hourly rate of $86.53 for a pharmacist, from the alternatives analysis 
above, the 10 additional seconds to record partial fills equates to 
$0.24.\38\ As discussed in the Cost Savings section above, DEA does not 
have a basis to estimate the percentage of the estimated 36,375,279 
prescriptions per year that would be partially filled. Therefore, for 
the purposes of this analysis, DEA estimates the mid-point (50 
percent), or 18,187,640 prescriptions per year will be partially 
filled, requiring recording of the partial fill by the pharmacist at an 
annual cost of $4,365,034. This cost of $4,365,034 equates to an 
average of $232 per firm for pharmacies.\39\
---------------------------------------------------------------------------

    \37\ See note 2.
---------------------------------------------------------------------------

    The average cost of $24 per  firm for prescribers, and $232 per 
firm for pharmacies is a very high estimate for small entities, as 
small prescribing firms are expected to request less than an average 
number of partial fills per firm, and small pharmacies are expected to 
fill less than average partial fills per firm. Although these are high 
estimates, these costs were compared to the average annual revenue for 
the smallest of small entities. The average cost ranges from 0.009 
percent of revenue for the smallest of small hospitals, and 0.487 
percent for the smallest of small pharmacies. The table below 
summarizes this analysis for each of the industry codes.
---------------------------------------------------------------------------

    \38\ 10 seconds x (1 hour / 3,600 seconds) x ($60.64/hour x 
1.427) = $0.24.
    \39\ $4,365,034 / 18,852 = $232 (rounded to nearest whole 
dollar).

                                   Table 5--Average Cost as Percent of Revenue
----------------------------------------------------------------------------------------------------------------
                                                                               Revenue                 Cost as
     NAICS      NAICS description      Firm size in       Firms     Revenue    per firm   Cost per   percent of
                                       receipts ($)                 ($1,000)     ($)      firm ($)     revenue
----------------------------------------------------------------------------------------------------------------
446110........  Pharmacies and                <100,000        757     36,066     47,643        232         0.487
                 Drug Stores.
621111........  Offices of                    <100,000     15,275    771,280     50,493         24         0.048
                 Physicians
                 (except Mental
                 Health
                 Specialists).
621210........  Offices of                    <100,000      8,701    452,125     51,962         24         0.046
                 Dentists.
621491........  HMO Medical                   <100,000         24      1,266     52,750         24         0.045
                 Centers.
621493........  Freestanding                  <100,000        223     11,879     53,269         24         0.045
                 Ambulatory
                 Surgical and
                 Emergency
                 Centers.
622110........  General Medical      * 100,000-499,999         14      3,812    272,286         24         0.009
                 and Surgical
                 Hospitals.
----------------------------------------------------------------------------------------------------------------
* Revenue data not available for ``<100,000.'' Examined smallest size with available revenue data.
Source: SUSB.

    After normalizing the cost for revenue size of the affected firms 
by dividing the total cost by the total revenue for the affected 
industry, the cost as percent of revenue is much lower. As an industry, 
the cost as percent of revenue is 0.0005 percent and 0.0018 percent for 
prescribing firms and pharmacies, respectively. These percentages 
represent all firms, including small firms. The table below summarizes 
the normalized cost as percentage of revenue.

                             Table 5--Average Cost as Percent of Revenue, Normalized
----------------------------------------------------------------------------------------------------------------
                                                                                                       Cost as
      NAICS        NAICS description   Firm size in receipts    Firms       Revenue      Cost ($)    percent of
                                                                           ($1,000)                    revenue
----------------------------------------------------------------------------------------------------------------
446110..........  Pharmacies and Drug  All firms............     18,852   236,277,373    4,365,034        0.0018
                   Stores.
621111..........  Offices of           All firms............    174,901   402,159,295    7,275,056        0.0005
                   Physicians (except
                   Mental Health
                   Specialists).

[[Page 78293]]

 
621210..........  Offices of Dentists  All firms............    125,151   104,740,291
621491..........  HMO Medical Centers  All firms............        104     7,124,698
621493..........  Freestanding         All firms............      4,121    24,084,457
                   Ambulatory
                   Surgical and
                   Emergency Centers.
622110..........  General Medical and  All firms............      2,904   826,654,913
                   Surgical Hospitals.
----------------------------------------------------------------------------------------------------------------
Source: SUSB.

    If a patient received a partial fill pursuant to this proposed 
rule, and then returns to the pharmacy to receive another partial fill, 
or the remainder of the initial prescription, the pharmacist would 
require some additional time to fill the prescription. For example, if 
filling the remainder of the partial fill required ten additional 
minutes, based on the estimated loaded median hourly rate of $86.53 for 
a pharmacist, that additional time would equate to a cost of $14.42. 
However, DEA estimates these additional interactions will be minimal. 
As discussed earlier in reference to the 2017 study of post-surgical 
patients who were prescribed opioids, 71 percent of patients in the 
study did not use the entire prescription, and on average the patients 
only used 33 percent of the prescribed opioids. If prescribers and 
patients randomly asked for partial fills, only a small minority of 
patients would return for the remainder of the prescription. However, 
DEA does not anticipate the request for partial fills, at the request 
of the prescriber or the patient, to be random. Rather, DEA anticipates 
prescribers will exercise professional judgement and foresight in 
determining when a partial fill is best suited. DEA does not believe a 
partial fill will be requested by the prescriber when the prescriber 
believes the patient is likely to need all of the prescribed medicine. 
Furthermore, while the proposed rule would permit patients to request 
partial fills, DEA believes patients are unlikely to request a partial 
fill. Rather, the patient would follow the prescriber's instructions, 
based on consultation between the prescriber and the patient. 
Therefore, DEA believes any increase in the number of patient-pharmacy 
interactions related to patient-requested partial fills and resulting 
burden is de minimis.
    Therefore, DEA's evaluation of economic impact by size category 
indicates that the proposed rule, if promulgated, will not have a 
significant economic impact on a substantial number of these small 
entities.

Unfunded Mandates Reform Act of 1995

    In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 
2 U.S.C. 1501 et seq., DEA has determined and certifies that this 
action would not result in any Federal mandate that may 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 annually 
for inflation) in any 1 year.'' Therefore, neither a Small Government 
Agency Plan nor any other action is required under the UMRA of 1995.

Congressional Review Act

    This proposed rule is a major rule as defined by the Congressional 
Review Act, 5 U.S.C. 804. This proposed rule will result in an annual 
effect on the economy of $100,000,000 or more; DEA estimates this rule 
will result in a cost savings of $659 million per year over five years. 
However, it will not cause a major increase in costs or prices for 
consumers, individual industries, Federal, State, or local government 
agencies, or geographic regions; or significant adverse effects on 
competition, employment, investment, productivity, innovation, or on 
the ability of United States-based enterprises to compete with foreign-
based enterprises in domestic and export markets.

Paperwork Reduction Act of 1995

    Pursuant to section 3507(d) of the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3507(d)), DEA has identified the following collections 
of information related to this proposed rule. If adopted, this proposed 
rule would create additional recordkeeping requirements for pharmacies 
regarding partial fills. 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 Proposed Rule
    Title: Recordkeeping Requirements for Partial Fills of 
Prescriptions for Schedule II Controlled Substances.
    OMB Control Number: 1117-NEW.
    DEA Form Number: N/A.
    DEA is proposing to require pharmacies to create and maintain 
certain records relating to partial fills of prescriptions for schedule 
II controlled substances. When presented with a prescription for a 
schedule II controlled substance, on which the prescribing practitioner 
has properly specified his/her intent that the prescription be 
partially filled, the proposed rule would require the pharmacist to 
record the partial filling in a manner similar to that required under 
the existing regulations (for other circumstances).\40\ Specifically, 
upon each such partial filling requested by the prescribing 
practitioner, the dispensing pharmacist would need to make a notation 
of the quantity dispensed on the face of the written prescription, in 
the written record of the emergency oral prescription, or in the 
electronic prescription record (as is currently required under 21 CFR 
1306.13(a) when the pharmacist is unable to supply the full quantity 
called for in the prescription). For electronic prescriptions, there 
would need to be an electronic prescription record and the record would 
need to be permanently attached to the electronic prescription. Also, 
for each such partial filling, the pharmacy would be required to 
maintain a record with the date of each dispensing, the name or 
initials of the individual who dispensed the substance, and all other 
information required by 21 CFR 1306.22(c) for schedule III and IV 
prescription refills. For electronic prescriptions specifically, 
pharmacy applications would need to allow required information 
pertaining to

[[Page 78294]]

the quantity, date, and the dispenser to be linked to each electronic 
controlled substance prescription record (as currently required by 21 
CFR 1311.205(b)(10)).
---------------------------------------------------------------------------

    \40\ Longstanding DEA regulations, which would not be changed by 
this proposed rule, also allow the partial filling of a schedule II 
prescription where the pharmacist is unable to supply the full 
quantity called for in the prescription (Sec.  1306.13(a)) and for a 
patient in a long-term care facility or with a terminal illness 
(Sec.  1306.13(b) and (c)).
---------------------------------------------------------------------------

    As proposed, upon partially filling a prescription for a schedule 
II controlled substance at the request of a patient, dispensing 
pharmacists would need to make a notation on the face of the written 
prescription, in the written record of the emergency oral prescription, 
or in the electronic prescription record of the following: (1) 
``patient requested partial fill on [date such request was made]'' and 
(2) the quantity dispensed. In addition, for each such partial filling, 
the pharmacy would need to maintain a record of dispensing that 
includes the date of each dispensing, the name or initials of the 
individual who dispensed the substance, and all other information 
required by 21 CFR 1306.22(c) for schedule III and IV prescriptions. 
For electronic prescriptions specifically, such required information 
pertaining to the quantity dispensed, date dispensed, and the dispenser 
would need to be linked to each electronic controlled substance 
prescription record.
    DEA estimates the following number of respondents and burden 
associated with this collection of information:
    <bullet> Number of respondents: 68,676.
    <bullet> Frequency of response: Per occurrence (264.83255 per year, 
calculated).
    <bullet> Number of responses: 18,187,640 per year.
    <bullet> Burden per response: 0.002777778 hour (10 seconds).
    <bullet> Total annual hour burden: 50,521 hours.
    The activities described in this information collection are usual 
and ordinary business activities and no additional cost is anticipated.
B. Request for Comments Regarding the Proposed Collections of 
Information
    DEA is soliciting comment on the following issues related to these 
information collections:
    <bullet> The need for the information collection and its usefulness 
in carrying out the proper functions of DEA.
    <bullet> The accuracy of DEA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used.
    <bullet> The quality, utility, and clarity of the information to be 
collected.
    <bullet> Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collections of information are 
encouraged. Please send written comments to the Office of Information 
and Regulatory Affairs, OMB, Attention: Desk Officer for DOJ, 
Washington, DC 20503. Please state that your comments refer to RIN 
1117-AB45/Docket No. DEA-469. All comments must be submitted to OMB on 
or before February 2, 2021. The final rule will respond to any OMB or 
public comments on the information collection requirements contained in 
this proposal.

List of Subjects in 21 CFR Part 1306

    Drug traffic control, Prescription drugs.
    For the reasons set out above, DEA proposes to amend 21 CFR part 
1306 as follows:

PART 1306--PRESCRIPTIONS

0
1. The authority citation for part 1306 continues to read as follows:

    Authority:  21 U.S.C. 821, 823, 829a, 831, 871(b) unless 
otherwise noted.

0
2. In Sec.  1306.13, redesignate paragraphs (b) and (c) as paragraphs 
(c) and (d), and add a new paragraph (b) to read as follows:


Sec.  1306.13   Partial filling of prescriptions.

* * * * *
    (b) Partial filling of a prescription for a schedule II controlled 
substance at the request of the prescribing practitioner or patient:
    (1) General requirements. A prescription for a controlled substance 
in schedule II may be partially filled if all of the following 
conditions are satisfied:
    (i) It is not prohibited by State law;
    (ii) The prescription is written and filled in accordance with the 
Act, this chapter, and State law. A prescription written for a quantity 
that exceeds the limits of State law is not a valid prescription, 
therefore, the prescription may not be filled as written. Because such 
a prescription is not valid, it also cannot be partially filled;
    (iii) The partial fill is requested by the patient or by the 
practitioner who wrote the prescription; and
    (iv) The total quantity dispensed in all partial fillings does not 
exceed the total quantity prescribed.
    (2) Time limitations on filling the remaining portions of a 
partially filled prescription for a schedule II controlled substance. 
If all the conditions of paragraph (b)(1) of this section are 
satisfied, and the prescription is partially filled, remaining portions 
of a partially filled prescription for a controlled substance in 
schedule II, if filled, must be filled not later than 30 days after the 
date on which the prescription is written, except that in the case of 
an emergency oral prescription, as described in subsection 309(a) of 
the Act (21 U.S.C. 829(a)), the remaining portions of a partially 
filled prescription for a controlled substance in schedule II, if 
filled, must be filled not later than 72 hours after the prescription 
is issued.
    (3) How a practitioner may request that a prescription for a 
schedule II controlled substance be partially filled. Where a 
practitioner issues a prescription for a schedule II controlled 
substance and wants the prescription to be partially filled, the 
practitioner must specify the quantity to be dispensed in each partial 
filling on the face of the written prescription, in the written record 
of the emergency oral prescription, or in the electronic prescription 
record. This information must be included on the prescription, along 
with the other information required by Sec.  1306.05, at the time the 
practitioner signs the prescription or, in the case of an emergency 
oral prescription, this information must be communicated by the 
prescribing practitioner to the pharmacist.
    (4) How a patient may request that a prescription for a schedule II 
controlled substance be partially filled. A patient may request that 
his/her prescription for a schedule II controlled substance be 
partially filled. Such a request by the patient may be made: In person, 
in writing if signed by the patient, or by a phone call from the 
patient to the pharmacist. Where a practitioner has requested the 
partial filling of a prescription in accordance with paragraph (b)(3) 
of this section, the patient may not request a partial filling in an 
amount greater than that specified by the practitioner.
    (5) How a pharmacy must record the partial filling of a 
prescription for a schedule II controlled substance. (i) Upon partially 
filling a prescription at the request of the prescribing practitioner 
in accordance with paragraph (b)(3) of this section, the pharmacist 
must make a notation of the quantity dispensed on the face of the 
written prescription, in the written record of the emergency oral 
prescription, or in the electronic prescription record. In addition, 
for each such partial filling, the pharmacy must maintain a record of 
dispensing that includes the date of each dispensing, the name or 
initials of the individual who dispensed the substance, and all other 
information required by 21 CFR 1306.22(c) for schedule III and IV 
prescription refills. For electronic prescriptions specifically,

[[Page 78295]]

such required information pertaining to the quantity dispensed, date 
dispensed, and the dispenser must be linked to each electronic 
controlled substance prescription record.
    (ii) Upon partially filling a prescription at the request of the 
patient in accordance with paragraph (b)(4) of this section, the 
pharmacist must make a notation on the face of the written 
prescription, in the written record of the emergency oral prescription, 
or in the electronic prescription record of the following: (I) 
``patient requested partial fill on [date such request was made]'' and 
(II) the quantity dispensed. In addition, for each such partial 
filling, the pharmacy must maintain a record of dispensing that 
includes the date of each dispensing, the name or initials of the 
individual who dispensed the substance, and all other information 
required by 21 CFR 1306.22(c) for schedule III and IV prescriptions. 
For electronic prescriptions specifically, such required information 
pertaining to the quantity dispensed, date dispensed, and the dispenser 
must be linked to each electronic controlled substance prescription 
record.
* * * * *

Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-26291 Filed 12-3-20; 8:45 am]
BILLING CODE 4410-09-P