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period on the draft guidance ended on 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
Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 2793 

adequate directions for use) and section 

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

approval of human drug products under 

new drug applications or abbreviated 

new drug applications). 

One condition of section 503A is that 

a compounder ‘‘does not compound 

regularly or in inordinate amounts (as 

defined by the Secretary) any drug 

products that are essentially copies of a 

commercially available drug product’’ 

(section 503A(b)(1)(D)). However, for 

the purposes of this section, ‘‘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)). 

The draft guidance states that if a 

compounder intends to rely on such a 

determination to establish that a 

compounded drug is not essentially a 

copy of a commercially available drug 

product, the compounder should ensure 

that the determination is documented 

on a prescription. If a prescription does 

not make clear that the prescriber made 

the determination required by section 

503A(b)(2), or a compounded drug is 

substituted for the commercially 

available product at the pharmacy, the 

compounder may contact the prescriber 

and if the prescriber confirms it, make 

a notation on the prescription that the 

compounded product contains a change 

that makes a significant difference for 

the patient. The notations should be as 

specific as those described in this 

document, and the date of the 

conversation with the prescriber should 

be included on the prescription. 

In addition, if the drug was 

compounded because the approved 

product was not commercially available 

because it was on the FDA drug shortage 

list, the prescription or a notation on the 

prescription should note that it was on 

the drug shortage list and the date the 

list was checked. 

Finally, compounders under section 

503A should maintain records of the 

frequency in which they have 

compounded drug products that are 

essentially copies of commercially 

available drug products and the number 

of prescriptions that they have filled for 

compounded drug products that are 

essentially copies of commercially 

available drug products to document 

that such compounding has not been 

done ‘‘regularly’’ or in ‘‘inordinate 

amounts.’’ 

FDA received 88 comments on the 

draft guidance, several of which raised 

issues pertaining to the information 

collection provisions in the draft 

guidance. The issues raised are 

addressed below. 

Issue One: One commenter proposed 

that any compounded drug with the 

same Active Pharmaceutical Ingredient 

(API) as a commercially available drug 

product should be considered to be 

‘‘essentially a copy’’ of the 

commercially available drug product. 

FDA Response to Issue One: FDA has 

not made this proposed change. A 

compounded drug with the same API as 

a commercially available drug product 

may be very different from that 

commercially available drug product. 

For example, it may have a different 

route of administration and a 

substantially different strength. In such 

cases, a prescriber determination is not 

needed because the compounded drug 

would not be considered to be 

‘‘essentially a copy’’ of the 

commercially available drug product, 

even if it had the same API. 

Issue Two: Several individuals 

submitted comments requesting the 

collection of additional information 

than what was proposed in the draft 

guidance. 

• One commenter requested that the 

medical record maintained by the 

prescriber should include additional 

scientific rationale for prescribing the 

compounded product. 

• Another commenter requested 

documentation to justify the use of a 

bulk drug substance to compound a 

product that could have been made 

starting with FDA-approved products. 

FDA Response to Issue Two: 

Regarding the first comment, this 

recommendation regarding what 

information a prescriber should 

maintain is outside the scope of this 

guidance. Regarding the second 

comment, the proposal is beyond the 

scope of the current guidance and we 

express no opinion on the proposed 

analysis and documentation. 

Issue Three: Several individuals 

submitted comments regarding 

collection of the prescriber 

determination in the hospital setting. 

• Some commenters noted the 

prescriber determination is not 

necessary in the hospital setting because 

pharmacists often determine when a 

compounded drug is needed for a 

patient and not the prescriber. For 

example, one commenter noted that 

hospitals may have standing policies 

that specify use of compounded drugs 

in certain scenarios. 

• Other commenters suggested use of 

a template or ‘‘blanket’’ prescriber 

determination statement when certain 

drugs are needed for a patient 

population on a consistent basis. 

• Another commenter noted that 

State scope of practice acts or hospital 

policy may prohibit pharmacists from 

writing in the patient chart or altering 

the electronic health record. 

FDA Response to Issue Three: FDA 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. 

Issue Four: Several individuals 

commented that it would be 

burdensome to document the prescriber 

determination, as well as to call a 

prescriber to document a prescriber 

determination when such determination 

is not evident on the original 

prescription. Individuals felt a 

prescriber determination should not be 

necessary in certain cases, such as when 

a prescription indicates a compounded 

drug. 

FDA Response to Issue Four: Section 

503A(b)(2) provides that a compounded 

drug is not essentially a copy of a 

commercially available drug product if 

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. If a prescription already 

documents the prescriber’s 

determination of significant difference, 

there is no additional documentation 

burden for the compounder. However, if 

a prescription does not make clear that 

the prescriber made the determination 

required by section 503A(d)(2), or a 

compounded drug is substituted for the 

commercially available product at the 

pharmacy, the compounder may contact 

the prescriber, and if the prescriber 

confirms it, make a notation on the 

prescription that the compounded 

product contains a change that makes a 

significant difference for the patient. 

FDA estimates this contact will take 3 

minutes and should not present 

significant burden. Maintaining 

prescription records that may include 

such notations should not present any 

additional burden, as FDA understands 

that maintaining records of 

prescriptions for compounded drug 

products is part of the usual course of 

the practice of compounding and selling 

drugs and is required by States’ 

pharmacy laws and other State laws 

governing recordkeeping by health care 

professionals and health care facilities. 

Finally, FDA notes that calling a 

prescriber to document a prescriber 

determination of significant difference 

is not a requirement. For example, the 


daltland on DSKBBV9HB2PROD with NOTICES
2794 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 

compounder has the option of not filling 

a prescription with a compounded drug 

if a prescriber determination is not 

provided. 

Issue Five: One commenter stated that 

requiring a notation on the prescription 

that a compounded drug was on the 

drug shortage list when compounded, 

and the date the list was checked, 

would be overly burdensome. 

FDA Response to Issue Five: FDA 

does not believe this presents a 

significant burden, as a compounder 

that wants to rely on a drug shortage to 

establish that a compounded drug is not 

essentially a copy of a commercially 

available drug would need to check 

FDA’s shortage website. Noting the date 

the list was checked is not onerous, and 

is necessary for FDA to verify 

compliance during inspections. FDA 

estimates this activity would take 2 

minutes. 

Issue Six: One commenter requested 

clarity on how long records should be 

maintained; what specific information 

should be maintained; and when such 

records should be presented to FDA. 

FDA Response to Issue Six: FDA has 

revised the guidance to include a 

recommended duration of 3 years for 

maintaining records. The guidance 

describes the records that can be 

retained to demonstrate compliance. 

FDA may request to review such records 

during establishment inspections. 

FDA estimates the burden of this 

collection of information as follows: 

We estimate that annually a total of 

approximately 6,888 compounders 

(‘‘number of respondents’’ in table 1, 

line 1) will consult a prescriber to 

determine whether he or she has made 

a determination that the compounded 

drug has a change that produces a 

significant difference for a patient as 

compared to the comparable 

commercially available drug, and that 

the compounders will document this 

determination on approximately 

172,200 prescription orders for 

compounded drugs (‘‘total annual 

disclosures’’ in table 1, line 1). We 

estimate that the consultation between 

the compounder and the prescriber and 

adding a notation to each prescription 

that does not already document this 

determination will take approximately 3 

minutes per prescription order. 

In addition, we estimate that a total of 

approximately 6,888 compounders 

(‘‘number of respondents’’ in table 1, 

line 2) will document this information 

on approximately 344,400 prescription 

orders for compounded drugs (‘‘total 

annual disclosures’’ in table 1, line 2). 

We estimate that checking FDA’s drug 

shortage list and documenting this 

information will take approximately 2 

minutes per prescription order. 

We estimate that a total of 

approximately 3,444 compounders 

(‘‘number of recordkeepers’’ in table 2) 

will keep approximately 165,312 

records (‘‘total annual records’’). We 

estimate that maintaining the records 

will take approximately 2 minutes per 

record. 

TABLE 1—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1

Type of reporting Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average burden per 

disclosure Total hours 

Consultation between the compounder and prescriber and the notation on the prescription documenting the prescriber’s determination of significant difference.6,888 50 344,400 0.05 (3 minutes) ....... 17,220 

Checking FDA’s drug shortage list and documenting on the prescription that the drug is in 

shortage.

6,888 50 344,400 0.03 (2 minutes) ....... 10,332 

Total ................................................................... ........................ ........................ ........................ ................................... 27,552 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Type of recordkeeping Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden per 

recordkeeping Total hours 

Records of frequency and number of prescriptions 

filled for compounded drugs that are essentially a 

copy.

3,444 48 165,312 0.03 (2 minutes) ....... 4,959 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: January 16, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–00917 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–2018–N–0055] 

Gastrointestinal Drugs 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 Gastrointestinal Drugs 

Advisory Committee. The general 

function of the committee is to provide 

advice and recommendations to FDA on 

regulatory issues. The meeting will be 

open to the public. FDA is establishing 


daltland on DSKBBV9HB2PROD with NOTICES