2790 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 

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 https://

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 

10115(g)(5)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Conformance with 

IEC 60825–1 Ed. 3 and IEC 60601–2–22 

Ed.3.1 (Laser Notice No. 56)’’ to the 

Office of the Center Director, Guidance 

and Policy Development, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5431, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request. 

FOR FURTHER INFORMATION CONTACT: 

Patrick Hintz, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4228, Silver Spring, 

MD 20993–0002, 301–796–6927. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA recognizes that the IEC is a 

global organization that prepares and 

publishes international standards for 

electrical, electronic, and related 

technologies, including laser products. 

This means that manufacturers 

distributing products in the United 

States and other countries might have to 

ensure conformance of their products 

with IEC standards as well as comply 

with FDA regulatory requirements. 

Complying with FDA regulations and 

conforming to the identified IEC 

standards may cause manufacturers to 

duplicate their efforts. 

FDA acknowledges the advantages of 

a universal set of device-specific criteria 

and requirements. Moreover, FDA 

believes that under the circumstances 

described in this guidance, conformance 

with certain IEC standards would 

provide adequate protection of the 

public health and safety for laser 

products similar to FDA’s performance 

standards in §§ 1040.10 and 1040.11 (21 

CFR 1040.10 and 1040.11). FDA 

eventually intends to amend its 

standards for laser products at 

§§ 1040.10 and 1040.11 to harmonize 

many of its requirements with those of 

the IEC because FDA acknowledges the 

advantages of one set of criteria and 

requirements worldwide. 

On June 24, 2007, FDA’s Center for 

Devices and Radiological Health (CDRH) 

published a guidance entitled ‘‘Laser 

Products—Conformance with IEC 

60825–1 and IEC 60601–2–22; Guidance 

for Industry and FDA Staff (Laser Notice 

No. 50)’’ (https://www.fda.gov/ 

downloads/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/ucm094366.pdf). 

This draft guidance, when finalized, 

will not replace the recommendations 

provided in that 2007 guidance, and 

upon finalization of this guidance, 

manufacturers can follow either Laser 

Notice No. 50 or this guidance. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Laser Products—Conformance with 

IEC 60825–1 Ed. 3 and IEC 60601–2–22 

Ed.3.1 (Laser Notice No. 56)’’. 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. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

CDRH guidance documents is available 

at https://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. This 

guidance document is also available at 

https://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Laser Products—Conformance with 

IEC 60825–1 Ed. 3 and IEC 60601–2–22 

Ed.3.1 (Laser Notice No. 56)’’ may send 

an email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number 1500024 to identify 

the guidance you are requesting. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR 1002.10, 

1010.2, 1010.3, 1040.10, and 1040.11 

have been approved under OMB control 

number 0910–0025. 

Dated: January 12, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00898 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–2016–D–1309] 

Compounded Drug Products That Are 

Essentially Copies of a Commercially 

Available Drug Product Under Section 

503A of the Federal Food, Drug, and 

Cosmetic Act; Guidance for Industry; 

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 a 

guidance for industry entitled 

‘‘Compounded Drug Products That Are 

Essentially Copies of a Commercially 

Available Drug Product Under Section 

503A of the Federal Food, Drug, and 

Cosmetic Act.’’ One of the conditions to 

qualify for exemptions under section 

503A of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act), is that a 

drug product must be compounded by 

a licensed pharmacist or physician who 

does not compound regularly or in 

inordinate amounts any drug products 

that are essentially copies of a 

commercially available drug product. 

This guidance sets forth FDA policies 

regarding this provision of section 

503A, including the terms 

‘‘commercially available,’’ ‘‘essentially a 

copy of a commercially available drug 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 2791 

product,’’ and ‘‘regularly or in 

inordinate amounts.’’ 

DATES: The announcement of the 

guidance is published in the Federal 

Register on January 19, 2018. 

ADDRESSES: You may submit either 

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 

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– 

2016–D–1309 for ‘‘Compounded Drug 

Products That Are Essentially Copies of 

a Commercially Available Drug Product 

Under Section 503A of the Federal 

Food, Drug, and Cosmetic Act.’’ 

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 https://

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, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, 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 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 20993, 301–796–3110. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a final guidance for industry entitled 

‘‘Compounded Drug Products That Are 

Essentially Copies of a Commercially 

Available Drug Product Under Section 

503A of the Federal Food, Drug, and 

Cosmetic Act.’’ Section 503A (21 U.S.C. 

353a), added to the FD&C Act by the 

Food and Drug Administration 

Modernization Act of 1997, describes 

the conditions that must be satisfied for 

human drug products compounded by a 

licensed pharmacist in a State-licensed 

pharmacy or Federal facility, or by a 

licensed physician, to be exempt from 

the following three sections of the FD&C 

Act: 

• Section 501(a)(2)(B) (21 U.S.C. 351 

(a)(2)(B)) (concerning current good 

manufacturing practice requirements); 

• Section 502(f)(1) (21 U.S.C. 

352(f)(1)) (concerning the labeling of 

drugs with adequate directions for use); 

and 

• Section 505 (21 U.S.C. 355) 

(concerning the approval of drugs under 

new drug applications (NDAs) or 

abbreviated new drug applications 

(ANDAs)). 

One of the conditions that must be 

met for a compounded drug product to 

qualify for the exemptions under section 

503A of the FD&C Act is that it must be 

compounded by a licensed pharmacist 

or a licensed physician that does not 

compound regularly or in inordinate 

amounts (as defined by the Secretary of 

Health and Human Services) any drug 

products that are essentially copies of a 

commercially available drug product 

(section 503A(b)(1)(D)). 

The statute further states that the term 

‘‘essentially a copy of a commercially 

available drug product’’ does not 

include a drug product in which there 

is a change, made for an identified 

individual patient, which produces for 

that patient a significant difference, as 

determined by the prescribing 

practitioner, between the compounded 

drug and the comparable commercially 

available drug product (section 

503A(b)(2) of the FD&C Act). 

This guidance sets forth FDA’s 

policies concerning the ‘‘essentially a 

copy’’ provision under section 503A of 

the FD&C Act, including the terms 

‘‘commercially available,’’ ‘‘essentially a 

copy of a commercially available drug 

product,’’ and ‘‘regularly or in 

inordinate amounts.’’ 


daltland on DSKBBV9HB2PROD with NOTICES
2792 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 

In the Federal Register of July 11, 

2016 (81 FR 44881), 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 

approximately 88 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 a period 

of at least 3 years. In addition, to 

address questions raised in comments, 

FDA clarified that the policies in this 

guidance apply to a compounded drug 

product without regard to the source(s) 

of the active pharmaceutical ingredient 

(API) in that product, for example, the 

policies would apply regardless of 

whether the compounder used an API 

that was purchased as an isolate, or if 

the compounder modified a finished 

drug product containing an API. 

FDA received comments on the draft 

guidance from hospital organizations 

regarding the potential implications of 

the proposed policies in the draft 

guidance 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 convey our 

further thinking on the applicability of 

these policies to hospitals and health 

systems publicly 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 

a Commercially Available Drug Product 

Under Section 503A 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 

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 July 11, 2016, we 

gave interested persons 60 days to 

comment on the information collection 

provisions in the draft guidance (81 FR 

44881). 

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/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm or 

https://www.regulations.gov. 

Dated: January 16, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00915 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–2016–D–1309] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry on Compounded Drug 

Products That Are Essentially Copies 

of a Commercially Available Drug 

Product Under Section 503A of the 

Federal Food, Drug, and Cosmetic Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by February 

20, 2018. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910—NEW and 

title ‘‘Guidance for Industry on 

Compounded Drug Products that are 

Essentially Copies of a Commercially 

Available Drug Product Under Section 

503A of the Federal Food, Drug, and 

Cosmetic Act.’’ Also include the FDA 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Guidance for Industry on Compounded 

Drug Products That Are Essentially 

Copies of a Commercially Available 

Drug Product Under Section 503A of 

the Federal Food, Drug, and Cosmetic 

Act 

OMB Control Number 0910—NEW 

This information collection supports 

the above captioned Agency guidance 

document. In the Federal Register of 

July 11, 2016 (81 FR 44881), FDA 

announced the availability of a draft 

guidance for industry entitled 

‘‘Guidance for Industry on Compounded 

Drug Products That Are Essentially 

Copies of a Commercially Available 

Drug Product Under Section 503A of the 

Federal Food, Drug, and Cosmetic Act,’’ 

and included an analysis of the 

associated information collection. 

Section 503A of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 353a) describes conditions that 

must be met in order for compounded 

drugs to receive exemptions from 

certain sections of the FD&C Act, 

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

351(a)(2)(B)) (concerning current good 

manufacturing practice for drugs); 

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

(concerning the labeling of drugs with 


daltland on DSKBBV9HB2PROD with NOTICES