Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 2787 

• Section 505 (21 U.S.C. 355) 

(concerning the approval of drugs under 

new drug applications or abbreviated 

new drug applications); and 

• Section 582 (21 U.S.C. 360eee–1) 

(concerning drug supply chain security 

requirements). 

One of the conditions that must be 

met for a compounded drug product to 

qualify for the exemptions under section 

503B of the FD&C Act is that the drug 

is not essentially a copy of one or more 

approved drugs (section 503B(a)(5)). 

Section 503B(d)(2) defines essentially 

a copy of an approved drug as: 

• A drug that is identical or nearly 

identical to an approved drug, or a 

marketed drug not subject to section 

503(b) and not subject to approval in an 

application submitted under section 

505, unless, in the case of an approved 

drug, the drug appears on the drug 

shortage list in effect under section 506E 

at the time of compounding, 

distribution, and dispensing (section 

503B(d)(2)(A)) or 

• a drug, a component of which is a 

bulk drug substance that is a component 

of an approved drug or a marketed drug 

that is not subject to section 503(b) and 

not subject to approval in an application 

submitted under section 505, unless 

there is a change that produces for an 

individual patient a clinical difference, 

as determined by the prescribing 

practitioner, between the compounded 

drug and the comparable approved drug 

(section 503B(d)(2)(B)). 

This guidance sets forth FDA’s 

policies concerning the ‘‘essentially a 

copy’’ provision of section 503B of the 

FD&C Act. 

In the Federal Register of July 11, 

2016 (81 FR 44879), FDA issued a notice 

announcing the availability of the draft 

version of this guidance. The comment 

period on the draft guidance ended on 

October 11, 2016. FDA received 29 

comments on the draft guidance. In 

response to received comments or on its 

own initiative, FDA made several 

changes. For example, in response to 

requests in comments for direction on 

records retention, FDA added a 

recommendation that compounders 

maintain the records described in the 

guidance for at least 3 years. In addition, 

to address questions raised in 

comments, FDA clarified that the 

Agency does not intend to take action 

against an outsourcing facility for failing 

to compound in accordance with 

section 503B(a)(5) if it fills orders for a 

compounded drug that is essentially a 

copy of an approved drug that has been 

discontinued and is no longer marketed. 

FDA received comments from 

hospital organizations regarding the 

potential implications of proposed 

policies for the preparation of 

compounded drugs used in in-patient 

settings. The final guidance notes that 

FDA is considering the applicability of 

the policies described in this guidance 

to hospitals and health systems. We 

recognize that this issue is of interest to 

many stakeholders and will publicly 

convey our further thinking on the 

applicability of these policies to 

hospitals and health systems with an 

opportunity for comment. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This guidance represents the current 

thinking of FDA on ‘‘Compounded Drug 

Products That Are Essentially Copies of 

Approved Drug Products Under Section 

503B of the Federal Food, Drug, and 

Cosmetic Act.’’ It does not establish any 

rights for any person and is not binding 

on FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. This guidance is not 

subject to Executive Order 12866. 

II. Paperwork Reduction Act of 1995 

This guidance contains collections of 

information that are subject to review by 

OMB under the PRA (44 U.S.C. 3501– 

3520). Under the PRA, Federal Agencies 

must obtain approval from OMB for 

each collection of information they 

conduct or sponsor. ‘‘Collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3 and includes 

Agency requests or requirements that 

members of the public submit reports, 

keep records, or provide information to 

a third party. Section 3506(c)(2)(A) of 

the PRA (44 U.S.C. 3506(c)(2)(A)) 

requires Federal Agencies to provide a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information before submitting the 

collection to OMB for approval. To 

comply with this requirement, in the 

Federal Register of July 11, 2016, we 

gave interested persons 60 days to 

comment on the information collection 

provisions in the draft guidance. 

The information collection provisions 

in this guidance have been submitted to 

OMB for review as required by section 

3507(d) of the PRA. These provisions 

are not in effect until they display a 

currently valid OMB control number. 

FDA will publish a notice in the Federal 

Register announcing OMB’s decision 

regarding the information collection 

provisions in this guidance. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.regulations.gov. 

Dated: January 16, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00914 Filed 1–18–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1525] 

Mixing, Diluting, or Repackaging 

Biological Products Outside the Scope 

of an Approved Biologics License 

Application; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the availability of a final 

guidance for industry entitled ‘‘Mixing, 

Diluting, or Repackaging Biological 

Products Outside the Scope of an 

Approved Biologics License 

Application.’’ This final guidance 

describes the conditions under which 

FDA does not intend to take action 

against a State-licensed pharmacy, a 

Federal facility, or an outsourcing 

facility that mixes, dilutes, or 

repackages certain biological products 

outside the scope of an approved 

biologics license application (BLA). It 

also describes the conditions under 

which FDA does not intend to take 

action when a State-licensed pharmacy, 

a Federal facility, an outsourcing 

facility, or a physician prepares 

prescription sets of allergenic extracts 

for subcutaneous immunotherapy. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on January 19, 2018. 

ADDRESSES: You may submit electronic 

or written comments on Agency 

guidances at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 


daltland on DSKBBV9HB2PROD with NOTICES
2788 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2014–D–1525 for ‘‘Mixing, Diluting, or 

Repackaging Biological Products 

Outside the Scope of an Approved 

Biologics License Application.’’ 

Received comments will be placed in 

the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

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

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to http://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2201, 

Silver Spring, MD 20993–0002; or the 

Office of Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Avenue, Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: Sara 

Rothman, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 5197, Silver Spring, 

MD 20903, 301–796–3110; or Stephen 

Ripley, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7301, Silver Spring, 

MD 20993–0002, 240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a final guidance for industry entitled 

‘‘Mixing, Diluting, or Repackaging 

Biological Products Outside the Scope 

of an Approved Biologics License 

Application.’’ Certain licensed 

biological products may sometimes be 

mixed, diluted, or repackaged in a way 

not described in the approved labeling 

for the product to meet the needs of a 

specific patient. For example, for some 

biological products there is no licensed 

pediatric strength and/or dosage form. 

In addition, there may be certain 

circumstances when a person would 

remove a licensed biological product 

from its original container and place it 

into a different container(s) (repackage 

it), in a manner that is not within the 

scope of the approved labeling for the 

product. As described in the guidance, 

mixed, diluted, or repackaged biological 

products are not eligible for the 

statutory exemptions available to certain 

compounded drugs under sections 503A 

and 503B of the FD&C Act (21 U.S.C. 

353a and 353b). In addition, a biological 

product that is mixed, diluted, or 

repackaged outside the scope of an 

approved BLA is considered an 

unlicensed biological product under 

section 351 of the Public Health Service 

(PHS) Act (42 U.S.C. 262). 

This guidance describes the 

conditions under which FDA does not 

intend to take action for violations of 

section 351 of the PHS Act, and section 

502(f)(1) (21 U.S.C. 352(f)(1)), section 

582 (21 U.S.C. 360eee–1), and where 

specified, section 501(a)(2)(B) (21 U.S.C. 

351(a)(2)(B)) of the FD&C Act, when a 

state-licensed pharmacy, a Federal 

facility, or an outsourcing facility 

dilutes, mixes, or repackages certain 

biological products outside the scope of 

an approved BLA. 

In the Federal Register of January 13, 

2017 (82 FR 4358), FDA issued a notice 

announcing the availability of the 

revised draft version of this guidance. 

The comment period on the draft 

guidance ended on March 14, 2017. 

FDA received 11 comments on the 

revised draft guidance. In response to 

received comments or on its own 

initiative, FDA made revisions to clarify 

certain points. For example, FDA added 

a footnote indicating that the Agency is 

considering the applicability of the 

policies described in this guidance to 

hospitals and health systems and 

intends to address these issues in 

separate guidance. FDA also clarified 

that one of the conditions under which 

the Agency does not intend to take 

action for the violations listed above is 

that any components used in mixing or 

diluting a licensed biological product 

are sterile, pharmaceutical grade, and 

otherwise appropriate for such use. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on mixing, diluting, or 

repackaging biological products outside 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 2789 

the scope of an approved BLA. It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

This guidance contains collections of 

information that are subject to review by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act (PRA) of 1995 (44 U.S.C. 3501– 

3520). Under the PRA, Federal Agencies 

must obtain approval from OMB for 

each collection of information they 

conduct or sponsor. ‘‘Collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3 and includes 

Agency requests or requirements that 

members of the public submit reports, 

keep records, or provide information to 

a third party. Section 3506(c)(2)(A) of 

the PRA (44 U.S.C. 3506(c)(2)(A)) 

requires Federal Agencies to provide a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information before submitting the 

collection to OMB for approval. To 

comply with this requirement, in the 

Federal Register of January 13, 2017, we 

gave interested persons 60 days to 

comment on the information collection 

provisions in the draft guidance (82 FR 

4358 at 4359). 

The information collection provisions 

in this guidance will be submitted to 

OMB for review as required by section 

3507(d) of the PRA. These provisions 

are not in effect until they display a 

currently valid OMB control number. 

FDA will publish a notice in the Federal 

Register announcing OMB’s decision 

regarding the information collection 

provisions in this guidance. 

The guidance also references 

registration and adverse event reporting 

for outsourcing facilities. The 

collections of information for 

outsourcing facility registration have 

been approved by OMB under OMB 

control number 0910–0777. The 

collections of information for adverse 

event reporting by outsourcing facilities 

have been approved by OMB under 

OMB control number 0910–0800. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/Drugs/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm, 

https://www.fda.gov/Biologics

BloodVaccines/GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm, or https://

www.regulations.gov. 

Dated: January 16, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00916 Filed 1–18–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–7011] 

Laser Products—Conformance With 

IEC 60825–1 Ed. 3 and IEC 60601–2–22 

Ed. 3.1 (Laser Notice No. 56); Draft 

Guidance for Industry and Food and 

Drug Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the draft 

guidance entitled ‘‘Conformance with 

IEC 60825–1 Ed. 3 and IEC 60601–2–22 

Ed. 3.1 (Laser Notice No. 56).’’ This 

draft guidance describes the Agency’s 

proposed approach regarding 

compliance with FDA’s performance 

standards for laser products. FDA 

believes that under the circumstances 

described in this guidance, conformance 

with certain International 

Electrotechnical Commission (IEC) 

standards would provide adequate 

protection of the public health and 

safety for laser products similar to 

performance standards in FDA’s 

regulations. Accordingly, FDA does not 

intend to consider whether firms that 

comply with the comparable IEC 

standards discussed in this guidance 

document also comply with 

performance standards in FDA’s 

regulations. This draft guidance is not 

final nor is it in effect at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 20, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–D–7011 for ‘‘Conformance with 

IEC 60825–1 Ed. 3 and IEC 60601–2–22 

Ed.3.1 (Laser Notice No. 56).’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 


daltland on DSKBBV9HB2PROD with NOTICES