78282 Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Proposed Rules 

(a) Comments Due Date 

The FAA must receive comments by 

January 19, 2021. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to Airbus SAS Model 

A350–941 and A350–1041 airplanes, 

certificated in any category, as identified in 

European Union Aviation Safety Agency 

(EASA) AD 2020–0166, dated July 27, 2020 

(EASA AD 2020–0166). 

(d) Subject 

Air Transport Association (ATA) of 

America Code 53, Fuselage. 

(e) Reason 

This AD was prompted by reports that 

suitable corrosion protection treatment had 

not been applied to certain areas of the seat 

track. The FAA is issuing this AD to address 

a potential structural deficiency at certain 

seat track locations, providing insufficient 

resistance to environmental damage. This 

condition, if not addressed, could lead to seat 

or monument detachment during an 

emergency landing, possibly resulting in 

injury to occupants and preventing safe 

evacuation from the airplane. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Requirements 

Except as specified in paragraph (h) of this 

AD: Comply with all required actions and 

compliance times specified in, and in 

accordance with, EASA AD 2020–0166. 

(h) Exceptions to EASA AD 2020–0166 

(1) Where EASA AD 2020–0166 refers to its 

effective date, this AD requires using the 

effective date of this AD. 

(2) The ‘‘Remarks’’ section of EASA AD 

2020–0166 does not apply to this AD. 

(i) No Reporting Requirement 

Although the service information 

referenced in EASA AD 2020–0166 specifies 

to submit certain information to the 

manufacturer, this AD does not include that 

requirement. 

(j) Other FAA AD Provisions 

The following provisions also apply to this 

AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, Large Aircraft 

Section, International Validation Branch, 

FAA, has the authority to approve AMOCs 

for this AD, if requested using the procedures 

found in 14 CFR 39.19. In accordance with 

14 CFR 39.19, send your request to your 

principal inspector or responsible Flight 

Standards Office, as appropriate. If sending 

information directly to the Large Aircraft 

Section, International Validation Branch, 

send it to the attention of the person 

identified in paragraph (k)(2) of this AD. 

Information may be emailed to: 9-AVS-AIR730-AMOC@faa.gov. Before using any 

approved AMOC, notify your appropriate 

principal inspector, or lacking a principal 

inspector, the manager of the responsible 

Flight Standards Office. 

(2) Contacting the Manufacturer: For any 

requirement in this AD to obtain instructions 

from a manufacturer, the instructions must 

be accomplished using a method approved 

by the Manager, Large Aircraft Section, 

International Validation Branch, FAA; or 

EASA; or Airbus SAS’s EASA Design 

Organization Approval (DOA). If approved by 

the DOA, the approval must include the 

DOA-authorized signature. 

(3) Required for Compliance (RC): For any 

service information referenced in EASA AD 

2020–0166 that contains RC procedures and 

tests: Except as required by paragraph (j)(2) 

of this AD, RC procedures and tests must be 

done to comply with this AD; any procedures 

or tests that are not identified as RC are 

recommended. Those procedures and tests 

that are not identified as RC may be deviated 

from using accepted methods in accordance 

with the operator’s maintenance or 

inspection program without obtaining 

approval of an AMOC, provided the 

procedures and tests identified as RC can be 

done and the airplane can be put back in an 

airworthy condition. Any substitutions or 

changes to procedures or tests identified as 

RC require approval of an AMOC. 

(k) Related Information 

(1) For information about EASA AD 2020– 

0166, contact the EASA, Konrad-AdenauerUfer 3, 50668 Cologne, Germany; telephone 

+49 221 8999 000; email ADs@

easa.europa.eu; internet 

www.easa.europa.eu. You may find this 

EASA AD on the EASA website at https://

ad.easa.europa.eu. You may view this 

material at the FAA, Airworthiness Products 

Section, Operational Safety Branch, 2200 

South 216th St., Des Moines, WA. For 

information on the availability of this 

material at the FAA, call 206–231–3195. This 

material may be found in the AD docket on 

the internet at https://www.regulations.gov 

by searching for and locating Docket No. 

FAA–2020–1106. 

(2) For more information about this AD, 

contact Kathleen Arrigotti, Aerospace 

Engineer, Large Aircraft Section, 

International Validation Branch, FAA, 2200 

South 216th St., Des Moines, WA 98198; 

telephone and fax 206–231–3218; email 

kathleen.arrigotti@faa.gov. 

Issued on November 30, 2020. 

Lance T. Gant, 

Director, Compliance & Airworthiness 

Division, Aircraft Certification Service. 

[FR Doc. 2020–26684 Filed 12–3–20; 8:45 am] 

BILLING CODE 4910–13–P 

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. 

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 

Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Proposed Rules 78283 

1 ‘‘Safe Disposal of Unused Controlled 

Substances: Current Challenges and Opportunities 

for Reform,’’ Avalere, http://www.ncdoi.com/osfm/ 

safekids/documents/omd/safedisposal

ofunusedcontrolledsubstancesreport.pdf. 

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 copay 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. 

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 

78284 Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Proposed Rules 

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. 

3Longstanding 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 (§ 1306.13(a)) and for 

a patient in a long-term care facility or with a 

terminal illness (§ 1306.13(b) and (c)). 

percent); physician asked to stop it (4.3 

percent); or other reason (15.8 percent).2

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)). 

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 

Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Proposed Rules 78285 

4BLS, May 2018 National Occupational 

Employment and Wage Estimates, United States. 

https://www.bls.gov/oes/current/oes_nat.htm. 

(Accessed 2/6/2020.) 

5BLS, ‘‘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. 

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: 

§ 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

• Pharmacist requesting consent: 29– 

1051 Pharmacists, $60.64. 

• Prescriber’s representative to give 

consent: 43–6033 Medical Secretaries, 

$17.19. 

• 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

• Pharmacist requesting consent: 29– 

1051 Pharmacists, $86.53. 

• Prescriber’s representative to give 

consent: 43–6033 Medical Secretaries, 

$24.53. 

78286 Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Proposed Rules 

• 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 

Loaded 

hourly wage 

($) 

Time 

required 

(hours) 

Cost per 

occurrence 

($) 

Number of 

occurrences 

Total cost 

($M) 

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 

Total .............................................................................. N/A N/A 13.75 N/A 25.0 

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 wage 

($) 

Time 

required 

(hours) 

Cost per 

occurrence 

($) 

Number of 

occurrences 

Total cost 

($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 

Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Proposed Rules 78287 

6 ‘‘Safe Disposal of Unused Controlled 

Substances: Current Challenges and Opportunities 

for Reform,’’ Avalere, http://www.ncdoi.com/osfm/ 

safekids/documents/omd/safedisposal

ofunusedcontrolledsubstancesreport.pdf. 

7 ‘‘Opioid Overdose Crisis,’’ National Institute on 

Drug Abuse, https://www.drugabuse.gov/drugsabuse/opioids/opioid-overdose-crisis. (Accessed 2/ 

12/2020.) 

8 ‘‘Prescription of opioids for acute pain in opioid 

naı ̈ve patients,’’ 2019, Carlos A Pino, MD, Melissa 

Covington, MD, Uptodate.com, Wolters Kluwer. 

https://www.uptodate.com/contents/prescriptionof-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. 

10Empowering 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. 

11Florence 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. 

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 notificationrelated 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 naı ̈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

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. 

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 

78288 Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Proposed Rules 

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. 

18For 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. 19Empowering 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. 

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). 

24Siler, S., Duda, S., Brown, R., Gbemudu, J., 

Weiner, S., & Glaudemans, J. (n.d.). Safe Disposal 

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. 

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% × 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 × 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 

Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Proposed Rules 78289 

of Unused Controlled Substances. Retrieved 

September 21, 2018, from http://www.ncdoi.com/ 

osfm/safekids/documents/omd/safedisposal

ofunusedcontrolledsubstancesreport.pdf. 

25http://michigan-open.org/statewide-drugtakeback-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. 

27BLS, 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 × 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 × (1 hour / 3,600 seconds) × 

$144.74/hour = $0.40. 

29See note 2. 

30 10 seconds × (1 hour / 3,600 seconds) × $86.53/ 

hour = $0.24. 

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 

× $5.60 × .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). 

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. 

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. 

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 postsurgical 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 

78290 Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Proposed Rules 

31OMB Memorandum M–17–21 at 12. 

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 patientpharmacy 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 fiveyear 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. 

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 

Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Proposed Rules 78291 

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-forfederal-agencies. (Accessed 2/4/2020.) 

33U.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.) 

34For the purposes of this analysis, ‘‘firms’’ and 

‘‘entities’’ are used synonymously. 

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, SIXDIGIT 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

TABLE 4—ESTIMATED NUMBER OF AFFECTED SMALL ENTITIES

NAICS NAICS description Firms 

SBA size 

standard, 

annual 

revenue 

($M) 

Small 

entities 

446110 .... Pharmacies and Drug Stores ................................................................................. 18,852 30.0 18,503 

621111 .... Offices of Physicians (except Mental Health Specialists) ...................................... 174,901 12.0 170,287 

621210 .... Offices of Dentists .................................................................................................. 125,151 8.0 124,689 

621491 .... HMO Medical Centers ............................................................................................ 104 35.0 81 

621493 .... Freestanding Ambulatory Surgical and Emergency Centers ................................. 4,121 16.5 3,603 

622110 .... General Medical and Surgical Hospitals ................................................................ 2,904 41.5 1,199 

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 

78292 Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Proposed Rules 

35 10 seconds × (1 hour / 3,600 seconds) × 

($101.43/hour × 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). 

37See note 2. 

38 10 seconds × (1 hour / 3,600 seconds) × ($60.64/ 

hour × 1.427) = $0.24. 

39 $4,365,034 / 18,852 = $232 (rounded to nearest 

whole dollar). 

$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

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

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. 

TABLE 5—AVERAGE COST AS PERCENT OF REVENUE

NAICS NAICS description 

Firm size 

in receipts 

($) 

Firms Revenue 

($1,000) 

Revenue 

per firm 

($) 

Cost 

per firm 

($) 

Cost as 

percent of 

revenue 

446110 ... Pharmacies and Drug Stores ...................... <100,000 757 36,066 47,643 232 0.487 

621111 ... Offices of Physicians (except Mental Health 

Specialists).

<100,000 15,275 771,280 50,493 24 0.048 

621210 ... Offices of Dentists ....................................... <100,000 8,701 452,125 51,962 24 0.046 

621491 ... HMO Medical Centers ................................. <100,000 24 1,266 52,750 24 0.045 

621493 ... Freestanding Ambulatory Surgical and 

Emergency Centers.

<100,000 223 11,879 53,269 24 0.045 

622110 ... General Medical and Surgical Hospitals ..... * 100,000–499,999 14 3,812 272,286 24 0.009 

* 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

NAICS NAICS description Firm size 

in receipts Firms Revenue ($1,000) 

Cost 

($) 

Cost as 

percent of 

revenue 

446110 ... Pharmacies and Drug Stores .......................................... All firms .......... 18,852 236,277,373 4,365,034 0.0018 

621111 ... Offices of Physicians (except Mental Health Specialists) All firms .......... 174,901 402,159,295 7,275,056 0.0005 

Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Proposed Rules 78293 

40Longstanding 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 (§ 1306.13(a)) and for 

a patient in a long-term care facility or with a 

terminal illness (§ 1306.13(b) and (c)). 

TABLE 5—AVERAGE COST AS PERCENT OF REVENUE, NORMALIZED—Continued 

NAICS NAICS description Firm size 

in receipts Firms Revenue ($1,000) 

Cost 

($) 

Cost as 

percent of 

revenue 

621210 ... Offices of Dentists ........................................................... All firms .......... 125,151 104,740,291 

621491 ... HMO Medical Centers ..................................................... All firms .......... 104 7,124,698 

621493 ... Freestanding Ambulatory Surgical and Emergency Centers.All firms .......... 4,121 24,084,457 

622110 ... General Medical and Surgical Hospitals ......................... All firms .......... 2,904 826,654,913 

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 postsurgical 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 patientpharmacy 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 foreignbased 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 

78294 Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Proposed Rules 

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)). 

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: 

• Number of respondents: 68,676. 

• Frequency of response: Per 

occurrence (264.83255 per year, 

calculated). 

• Number of responses: 18,187,640 

per year. 

• Burden per response: 0.002777778 

hour (10 seconds). 

• 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: 

• The need for the information 

collection and its usefulness in carrying 

out the proper functions of DEA. 

• The accuracy of DEA’s estimate of 

the burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used. 

• The quality, utility, and clarity of 

the information to be collected. 

• 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 

■ 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. 

■ 2. In § 1306.13, redesignate 

paragraphs (b) and (c) as paragraphs (c) 

and (d), and add a new paragraph (b) to 

read as follows: 

§ 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 § 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, 

Federal Register / Vol. 85, No. 234 / Friday, December 4, 2020 / Proposed Rules 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 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

24 CFR Parts 5, 92, 93, 574, 960, 966, 

982 

[Docket No. FR–6057–P–02] 

RIN 2577–AD03 

Housing Opportunity Through 

Modernization Act of 2016: Re-Opening 

Public Comment Period on Subject of 

Over Income Families 

AGENCY: Office of the General Counsel, 

HUD. 

ACTION: Proposed rule; re-opening of 

comment period. 

SUMMARY: On September 17, 2019, HUD 

published a proposed rule 

implementing sections 102, 103 and 104 

of the Housing Opportunity through 

Modernization Act (HOTMA) of 2016. 

The comment period for the proposed 

rule closed on November 18, 2019. 

Among other things, § 960.507 of the 

rule proposed adding a section 

addressing the treatment of families in 

public housing whose family income 

exceeds the new limit in HOTMA. 

Before finalizing the rule, HUD seeks 

additional public comment on the 

implementation of the public housing 

income limit, specifically public 

housing agencies’ (PHAs’) discretion in 

addressing over-income families. This 

notice therefore re-opens the public 

comment period on the HOTMA 

proposed rule for an additional 30 days 

solely to seek comment on these specific 

issues. HUD is not soliciting comment 

on any other issues related to HUD’s 

September 17, 2019, proposed rule. 

DATES: The comment period for a 

specific topic in the proposed rule 

published on September 17, 2019 (84 FR 

48820), is re-opened. The due date for 

comments discussed in this 

supplemental notice of proposed 

rulemaking is January 4, 2021. 

ADDRESSES: Interested persons are 

invited to submit comments regarding 

this proposed rule. Copies of all 

comments submitted are available for 

inspection and downloading at 

www.regulations.gov. To receive 

consideration as public comments, 

comments must be submitted through 

one of two methods, specified below. 

All submissions must refer to the above 

docket number and title. 

1. Electronic Submission of 

Comments. Interested persons may 

submit comments electronically through 

the Federal eRulemaking Portal at 

www.regulations.gov. HUD strongly 

encourages commenters to submit 

comments electronically. Electronic 

submission of comments allows the 

commenter maximum time to prepare 

and submit a comment, ensures timely 

receipt by HUD, and enables HUD to 

make them immediately available to the 

public. Comments submitted 

electronically through the 

www.regulations.gov website can be 

viewed by other commenters and 

interested members of the public. 

Commenters should follow the 

instructions provided on that site to 

submit comments electronically. 

2. Submission of Comments by Mail. 

Comments may be submitted by mail to 

the Regulations Division, Office of 

General Counsel, Department of 

Housing and Urban Development, 451 

7th Street SW, Room 10276, 

Washington, DC 20410–0500. 

FOR FURTHER INFORMATION CONTACT: 

Aaron Santa Anna, Associate General 

Counsel for Legislation and Regulations, 

Office of General Counsel, Department 

of Housing and Urban Development, 

451 7th Street SW, Room 10282, 

Washington, DC 20410; telephone 

number 202–402–5300 (this is not a tollfree number). Individuals with hearingor speech-impairments may access this 

number via TTY by calling the toll-free 

Federal Relay Service during working 

hours at 1–800–877–8339. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On July 29, 2016, the president signed 

HOTMA into law (Pub. L. 114–201, 130 

Stat. 782). HOTMA makes numerous 

changes to statutes governing HUD 

programs. In particular, section 103 of 

HOTMA imposed an income limit on 

families residing in public housing. 

Specifically, section 103 provides that 

two years after the family has reached 

the income limit, PHAs have the option 

of requiring families to vacate their 

units within 6 months or allowing the 

families to stay, provided the families 

pay the higher of fair market rent or a 

rent equal the amount of the monthly 

subsidy for the unit. HOTMA requires 

HUD to determine the amount of 

subsidy through regulation. 

On November 29, 2016, HUD 

published a Federal Register notice (81 

FR 85996), seeking public input on how 

HUD should determine the income limit 

for public housing residents, pursuant 

to section 103 of HOTMA. HUD 

followed this notice with a July 26, 

2018, notice (83 FR 35490) that made 

some provisions of section 103 of 

HOTMA effective. 

On September 17, 2019, HUD 

published a proposed rule to update its 

regulations according to HOTMA’s 

statutory mandate. Additional details 

about the proposed rule may be found 

at 84 FR 48820 (September 17, 2019). In 

this proposed rule, HUD proposed a 

new 24 CFR 960.507, which would 

codify the implementation of treatment 

of over-income families in public 

housing, including how to determine 

the monthly subsidy for such families’ 

units. 

While reviewing public comments 

and developing the final rule, HUD 

determined that it would be appropriate 

and helpful to obtain additional public 

comment on very specific aspects of 

HUD’s implementation of the income 

limit for public housing. HUD believes 

that HOTMA provides that families who 

are over-income (OI) under HOTMA for 

two consecutive years are no longer 

public housing tenants eligible for the 

public housing program and the PHA 

must terminate the families’ 

participation in the public housing 

program, even if they are allowed to 

remain in their units. Because these 

families would no longer be public 

housing tenants, they would not be 

subject to public housing regulations 

such as 24 CFR part 960 (including 

income reexamination requirements), 

and HUD would have no statutory basis 

to directly regulate these unassisted