49632 Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices 

Dated: October 20, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–23224 Filed 10–25–17; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5818] 

Pharmacy Compounding Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Pharmacy Compounding 

Advisory Committee (PCAC). The 

general function of the committee is to 

provide advice on scientific, technical, 

and medical issues concerning drug 

compounding under the Federal Food, 

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

and, as required, any other product for 

which FDA has regulatory 

responsibility, and to make appropriate 

recommendations to the Agency. The 

meeting will be open to the public. 

DATES: The meeting will be held on 

November 20, 2017, from 8:30 a.m. to 5 

p.m. and November 21, 2017, from 8:30 

a.m. to 11:30 a.m. 

ADDRESSES: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Answers to commonly asked questions, 

including information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2017–N–5818. 

The docket will close on November 17, 

2017. Submit either electronic or 

written comments on this public 

meeting by November 17, 2017. Please 

note that late, untimely filed comments 

will not be considered. Electronic 

comments must be submitted on or 

before November 17, 2017. The https:// 

www.regulations.gov electronic filing 

system will accept comments until 

midnight Eastern Time at the end of 

November 17, 2017. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Comments received on or before 

November 3, 2017, will be provided to 

the committee. Comments received after 

that date will be taken into 

consideration by the Agency. 

You may submit comments 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–N–5818 for ‘‘Pharmacy 

Compounding Advisory Committee; 

Notice of Meeting; Establishment of a 

Public Docket; Request for Comments.’’ 

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. 

FOR FURTHER INFORMATION CONTACT: 

Cindy Chee, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, Rm. 2417, Silver Spring, 

MD 20993–0002, 301–796–9001, Fax: 

301–847–8533, email: PCAC@

fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 


ethrower on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices 49633 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. 

SUPPLEMENTARY INFORMATION: 

Background: Section 503A of the 

FD&C Act (21 U.S.C. 353a) describes the 

conditions that must be satisfied for 

human drug products compounded by a 

licensed pharmacist in a State licensed 

pharmacy or a Federal facility, or a 

licensed physician, to be exempt from 

the following three sections of the FD&C 

Act: (1) Section 501(a)(2)(B) (21 U.S.C. 

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

manufacturing practice (CGMP)); (2) 

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

(concerning the labeling of drugs with 

adequate directions for use); and (3) 

section 505 (21 U.S.C. 355) (concerning 

the approval of human drug products 

under new drug applications (NDAs) or 

abbreviated new drug applications 

(ANDAs)). 

The Drug Quality and Security Act 

added a new section 503B to the FD&C 

Act (21 U.S.C. 353b), which created a 

new category of compounders termed 

‘‘outsourcing facilities.’’ Under section 

503B of the FD&C Act, outsourcing 

facilities are defined, in part, as 

facilities that meet certain conditions 

described in section 503B, including 

registration with FDA as an outsourcing 

facility. If these conditions are satisfied, 

a drug product compounded for human 

use by or under the direct supervision 

of a licensed pharmacist in an 

outsourcing facility is exempt from 

three sections of the FD&C Act: (1) 

Section 502(f)(1) (concerning the 

labeling of drugs with adequate 

directions for use); (2) section 505 

(concerning the approval of human drug 

products under NDAs or ANDAs); and 

(3) section 582 (21 U.S.C. 360eee–1) 

(concerning the drug supply chain 

security requirements). Outsourcing 

facilities are not exempt from CGMP 

requirements in section 501(a)(2)(B) of 

the FD&C Act. 

One of the conditions that must be 

satisfied to qualify for the exemptions 

under section 503A of the FD&C Act is 

that a bulk drug substance (active 

pharmaceutical ingredient) used in a 

compounded drug product must meet 

one of the following criteria: (1) 

Complies with the standards of an 

applicable United States Pharmacopoeia 

(USP) or National Formulary (NF) 

monograph, if a monograph exists, and 

the USP chapter on pharmacy 

compounding; (2) if an applicable 

monograph does not exist, is a 

component of a drug approved by the 

Secretary of Health and Human Services 

(the Secretary); or (3) if such a 

monograph does not exist and the drug 

substance is not a component of a drug 

approved by the Secretary, appears on a 

list developed by the Secretary through 

regulations issued by the Secretary (the 

‘‘503A Bulks List’’) (see section 

503A(b)(1)(A)(i) of the FD&C Act). 

Another condition that must be 

satisfied to qualify for the exemptions 

under section 503A of the FD&C Act is 

that the compounded drug product is 

not a drug product identified by the 

Secretary by regulation as a drug 

product that presents demonstrable 

difficulties for compounding that 

reasonably demonstrate an adverse 

effect on the safety or effectiveness of 

that drug product (see section 

503A(b)(3)(A) of the FD&C Act). 

A condition that must be satisfied to 

qualify for the exemptions in section 

503B of the FD&C Act is that the 

compounded drug is not identified 

(directly or as part of a category of 

drugs) on a list, published by the 

Secretary by regulation, of drugs or 

categories of drugs that present 

demonstrable difficulties for 

compounding that are reasonably likely 

to lead to an adverse effect on the safety 

or effectiveness of the drug or category 

of drugs, taking into account the risks 

and benefits to patients, or the drug is 

compounded in accordance with all 

applicable conditions identified on the 

list as conditions that are necessary to 

prevent the drug or category of drugs 

from presenting such demonstrable 

difficulties (see section 503B(a)(6)(A) 

and (B) of the FD&C Act). 

FDA intends to discuss with the 

committee bulk drug substances 

nominated for inclusion on the 503A 

Bulks List and drug products nominated 

for inclusion on the list of drug products 

that present demonstrable difficulties 

for compounding under sections 503A 

and 503B (‘‘Difficult to Compound 

List’’). 

Agenda: The committee intends to 

discuss six bulk drug substances 

nominated for inclusion on the section 

503A Bulks List. FDA will discuss the 

following nominated bulk drug 

substances: astragalus, L-citrulline, 

pregnenolone, 7-keto 

dehydroepiandrosterone (DHEA), 

epigallocatechin gallate (EGCg), and 

resveratrol. The chart below identifies 

the use(s) FDA reviewed for each of the 

six bulk drug substances being 

discussed at this advisory committee 

meeting. The nominators of these 

substances will be invited to make a 

short presentation supporting the 

nomination. 

Drug Uses reviewed 

Astragalus ....................................... Allergic rhinitis, asthma, diabetes, herpes simplex keratitis, wound healing. 

L-citrulline ........................................ Hyperammonaemia due to cycle disorders. 

Pregnenolone .................................. Rheumatoid arthritis, hypercholesterolemia, manic and depressive symptoms of bipolar disorder and bipolar disorder with substance abuse (dual diagnosis), positive and negative symptoms of schizophrenia. 

7-keto dehydroepiandrosterone ...... Weight loss, Raynaud’s phenomena. 

Epigallocatechin gallate .................. Treatment of obesity, wound healing, corneal neovascularization, non-alcoholic fatty liver disease, cardiac 

hypertrophy, diabetes (type 1 & 2), Parkinson’s disease. 

Resveratrol ...................................... Treatment of older adults with impaired glucose tolerance, pain. 

The committee also intends to discuss 

liposome drug products and drug 

products produced using hot melt 

extrusion technology for inclusion on 

the Difficult to Compound List. Drug 

products produced ‘‘by extrusion or 

nanotechnology’’ were nominated for 

inclusion on the Difficult to Compound 

List. The nominators will be invited to 

make a short presentation supporting 

the nomination. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

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

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 


ethrower on DSK3G9T082PROD with NOTICES
49634 Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. All electronic and 

written submissions submitted to the 

Docket (see the ADDRESSES section) on 

or before November 3, 2017, will be 

provided to the committee. Oral 

presentations from the public will be 

scheduled between approximately 9:35 

a.m. and 9:45 a.m., 10:55 a.m. and 11:05 

a.m., 12 noon and 12:10 p.m., 2:05 p.m. 

and 2:15 p.m., 3:25 p.m. and 3:35 p.m., 

and 4:30 p.m. and 4:40 p.m. on 

November 20, 2017, and between 

approximately 9:40 a.m. and 9:50 a.m. 

and 11:10 a.m. and 11:20 a.m. on 

November 21, 2017. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before October 

26, 2017. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by October 27, 2017. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Cindy Chee at 

least 7 days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: October 20, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–23223 Filed 10–25–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0961] 

Matthew Schroeder; Denial of Hearing; 

Final Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is denying 

Matthew Schroeder’s (Schroeder’s) 

request for a hearing and is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) 

permanently debarring Schroeder from 

providing services in any capacity to a 

person that has an approved or pending 

drug product application. FDA bases 

this order on a finding that Schroeder 

was convicted of a felony under Federal 

law for conduct relating to the 

regulation of a drug product under the 

FD&C Act. Schroeder failed to file with 

the Agency information and analyses 

sufficient to create a basis for a hearing 

concerning this action. 

DATES: This order is applicable October 

26, 2017. 

ADDRESSES: Any application by 

Schroeder for special termination of 

debarment under section 306(d) of the 

FD&C Act (application) may be 

submitted as follows: 

Electronic Submissions 

• Federal eRulemaking Portal: 

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

instructions for submitting comments. 

An application submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

application will be made public, you are 

solely responsible for ensuring that your 

application 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 

application, that information will be 

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

• If you want to submit an 

application with confidential 

information that you do not wish to be 

made available to the public, submit the 

application 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 a written/paper application 

submitted to the Dockets Management 

Staff, FDA will post your application, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: Your application must 

include the Docket No. FDA–2013–N– 

0961. An application will be placed in 

the docket and, unless 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 an application with confidential 

information that you do not wish to be 

made publicly available, submit your 

application 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 your application. 

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 application 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, 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 between 9 a.m. 


ethrower on DSK3G9T082PROD with NOTICES