8884 Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Biological product mixing, diluting, and repackaging Number of 

respondents 

Frequency per 

disclosure 

Total 

disclosures 

Hours per 

disclosure Total hours 

Designing, testing, and producing the label, container, 

packages, and/or outer containers for each mixed, diluted, or repackaged biological product ......................... 5 5 25 0.5 12 .5 

Prescribing information labeling accompanying each 

mixed, diluted, or repackaged drug product .................. 5 5 25 1 25 

Total ............................................................................ ........................ ........................ ........................ ........................ 37 .5 

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

*(30 minutes) 

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Preparation of prescription sets Number of 

respondents 

Frequency per 

disclosure 

Total 

disclosures 

Hours per 

disclosure Total hours 

Designing, testing, and producing each label on immediate containers, packages, and/or outer containers ..... 5 300 1500 0.5 750 

Including instructions for use labeling and the original 

package insert(s) for each prescription set .................... 5 300 1500 1 1500 

Total ............................................................................ ........................ ........................ ........................ ........................ 2250 

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

*(30 minutes) 

The draft guidance also references 

registration, product reporting, current 

good manufacturing practice (CGMP) 

requirements, and the payment of 

certain fees by human drug 

compounding outsourcing facilities. In 

the Federal Register of December 4, 

2013 (78 FR 72899), FDA estimated the 

burden resulting from outsourcing 

facility registration. In the Federal 

Register of December 4, 2013 (78 FR 

72897), FDA estimated the burden 

resulting from outsourcing facility 

interim product reporting. In the 

Federal Register of April 1, 2014 (79 FR 

18297), FDA estimated the burden 

resulting from the payment of certain 

fees by outsourcing facilities. In the 

Federal Register of July 2, 2014 (79 FR 

37743), FDA estimated the burden 

resulting from outsourcing facility 

compliance with CGMP requirements. 

IV. Electronic Access 

Persons with access to the Internet 

can obtain the document at either 

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

ComplianceRegulatoryInformation/

Guidances/default.htm, http://

www.fda.gov/BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/default.htm or http://

www.regulations.gov. 

Dated: February 11, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03418 Filed 2–18–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1524] 

Repackaging of Certain Human Drug 

Products by Pharmacies and 

Outsourcing Facilities; Draft 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 draft 

guidance for industry entitled 

‘‘Repackaging of Certain Human Drug 

Products by Pharmacies and 

Outsourcing Facilities.’’ This guidance 

describes the conditions under which 

FDA does not intend to take action for 

violations of the Federal Food, Drug, 

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

a state-licensed pharmacy, a Federal 

facility, or an outsourcing facility 

repackages human drug products. 

When this guidance becomes final, 

the Agency may also consider 

withdrawing or revising other guidance 

documents that address human drug 

repackaging, including section 446.100 

of the Compliance Program Guidance 

(CPG) Manual, entitled ‘‘Regulatory 

Action Regarding Approved New Drugs 

and Antibiotic Drug Products Subjected 

to Additional Processing or other 

Manipulations,’’ which was issued in 

January 1991, and section 460.100 of the 

CPG Manual, entitled ‘‘Hospital 

Pharmacies—Status as Drug 

Manufacturer,’’ which was issued in 

October 1980. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by May 20, 2015. 

ADDRESSES: 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. 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. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: Gail 

Bormel, Food and Drug Administration, 

10001 New Hampshire Ave., Silver 

Spring, MD 20903, 301–796–3110. 

SUPPLEMENTARY INFORMATION: 

I. Announcement of Draft Guidance 

FDA is announcing the availability of 

a draft guidance for industry entitled 


emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices 8885 

‘‘Repackaging of Certain Human Drug 

Products by Pharmacies and 

Outsourcing Facilities.’’ FDA regards 

repackaging as the act of taking a 

finished drug product from the 

container in which it was distributed by 

the original manufacturer and placing it 

into a different container without 

further manipulation of the drug. If a 

drug is manipulated in any other way, 

including if the drug is reconstituted, 

diluted, mixed, or combined with 

another ingredient, that act is not 

considered repackaging. 

Repackaged drugs are generally not 

exempt from any of the provisions of the 

FD&C Act related to the production of 

drugs. For example, repackaged drugs 

are generally subject to the premarket 

approval, misbranding, and adulteration 

provisions of the FD&C Act, including 

section 505 (concerning new drug 

applications), section 502(f)(1) 

(concerning labeling with adequate 

directions for use), and section 

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

manufacturing practice (CGMP) (21 

U.S.C. 355, 352(f)(1), and 351(a)(2)(B) of 

the FD&C Act). 

Further, drugs that are repackaged are 

not subject to sections 503A and 503B 

of the FD&C Act (21 U.S.C. 353a and 

353b). Therefore, drugs repackaged by 

state-licensed pharmacies, Federal 

facilities, or outsourcing facilities are 

not eligible for the exemptions provided 

under those sections. 

This draft guidance describes the 

conditions under which FDA does not 

intend to take action for violations of 

sections 505, 502(f)(1), and, where 

specified in the guidance, section 

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

state-licensed pharmacy, Federal 

facility, or registered outsourcing 

facility repackages drug products. The 

guidance does not address repackaging 

of nonprescription drugs; drugs that are 

intended for use in animals; biological 

products subject to licensure under 

section 351 of the Public Health 

Services Act (42 U.S.C. 262); 

repackaging by entities that are not 

state-licensed pharmacies, Federal 

facilities, or registered outsourcing 

facilities; removing a drug product from 

the original container at the point of 

care for immediate administration to a 

single patient after receipt of a patientspecific prescription or order for that 

patient; or repackaging a solid oral 

dosage form drug product by a statelicensed pharmacy for purposes of 

dispensing the drug to a patient upon 

receipt of an individual patient-specific 

prescription. 

Elsewhere in this issue of the Federal 

Register, the Agency is making available 

for comment a draft guidance entitled 

‘‘Mixing, Diluting, or Repackaging of 

Biological Products Outside the Scope 

of an Approved Biologics License 

Application.’’ When these two 

guidances become final, they will 

address and clarify the Agency’s policy 

regarding hospital pharmacies 

repackaging and safely transferring 

repackaged drugs to other hospitals 

within the same health system during a 

drug shortage. Therefore, under section 

506F(d) of the FD&C Act, when FDA 

issues these as final guidances, section 

506F will no longer apply. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This guidance, when finalized, will 

represent FDA’s current thinking on 

repackaging human drug products by 

pharmacies, Federal facilities, and 

outsourcing facilities. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Amendment or Withdrawal of 

Repackaging Guidance Documents 

When this guidance becomes final, 

the Agency may also consider 

withdrawing or revising other guidance 

documents that address human drug 

repackaging. These may include section 

446.100 of the CPG Manual, entitled 

‘‘Regulatory Action Regarding Approved 

New Drugs and Antibiotic Drug 

Products Subjected to Additional 

Processing or other Manipulations,’’ 

which was issued in January 1991, and 

section 460.100 of the CPG Manual, 

entitled ‘‘Hospital Pharmacies—Status 

as Drug Manufacturer,’’ which was 

issued in October 1980. 

III. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

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

will be posted to the docket at http://

www.regulations.gov. 

IV. Paperwork Reduction Act of 1995 

This draft guidance contains 

information collection provisions that 

are subject to review by the Office of 

Management and Budget under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). The title, 

description, and respondent description 

of the information collection are given 

under this section with an estimate of 

the annual reporting and recordkeeping 

burdens. Included in the estimate is the 

time for reviewing instructions, 

searching existing data sources, 

gathering and maintaining the data 

needed, and completing and reviewing 

the collection of information. 

We invite comments on these topics: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of FDA’s functions, 

including whether the information will 

have practical utility; (2) the accuracy of 

FDA’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Title: Repackaging of Certain Human 

Drug Products by Pharmacies and 

Outsourcing Facilities; Guidance for 

Industry. 

Description: The draft guidance 

describes repackaging by state-licensed 

pharmacies, Federal facilities, and 

outsourcing facilities under section 

503B of the FD&C Act, and it describes 

the conditions under which FDA does 

not intend to take action for violations 

of sections 505, 502(f)(1), and where 

specified, section 501(a)(2)(B) of the 

FD&C Act, when a state-licensed 

pharmacy, or Federal facility, or an 

outsourcing facility repackages drug 

products. The draft guidance includes 

the following collection of information 

under the PRA: 

One condition in the draft guidance is 

that if a drug is repackaged by an 

outsourcing facility, the label on the 

immediate container (primary 

packaging, e.g., the syringe) of the 

repackaged product includes the 

following information: 

• The statement ‘‘This drug product 

was repackaged by [name of outsourcing 

facility].’’ 

• The address and phone number of 

the outsourcing facility that repackaged 

the drug product. 

• The established name of the 

original, approved drug product that 

was repackaged. 

• The lot or batch number of the 

repackaged drug product. 

• The dosage form and strength of the 

repackaged drug product. 


emcdonald on DSK67QTVN1PROD with NOTICES
8886 Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices 

1The NDC number of the original approved drug 

product should not be placed on the repackaged 

drug product. 

• A statement of either the quantity or 

volume of the repackaged drug product, 

whichever is appropriate. 

• The date the drug product was 

repackaged. 

• The beyond-use-date of the 

repackaged drug product. 

• Storage and handling instructions 

for the repackaged drug product. 

• The National Drug Code (NDC) 

number of the repackaged drug product, 

if available.1

• The statement ‘‘Not for resale,’’ and, 

if the drug is distributed by an 

outsourcing facility other than pursuant 

to a prescription for an individual 

identified patient, the statement ‘‘Office 

Use Only.’’ 

• If included on the label of the FDAapproved drug product from which the 

drug product is being repackaged, a list 

of the active and inactive ingredients, 

unless such information is included on 

the label for the container from which 

the individual units are removed, as 

described in this document. 

In addition, a condition in the draft 

guidance is that the label on the 

container from which the individual 

units are removed for administration 

(secondary packaging, e.g., the bag, box, 

or other package in which the 

repackaged products are distributed) 

includes the active and inactive 

ingredients, if the immediate product 

label is too small to include this 

information, and directions for use, 

including, as appropriate, dosage and 

administration, and the following 

information to facilitate adverse event 

reporting: http://www.fda.gov/

medwatch and 1–800–FDA–1088. 

Another condition in the draft 

guidance is that each repackaged drug 

product is accompanied by a copy of the 

prescribing information that 

accompanied the original drug product 

that was repackaged. 

We estimate that annually a total of 

approximately 10 outsourcing facilities 

(‘‘Number of Respondents’’ in table 1, 

row 1) will each design, test, and 

produce approximately 10 different 

labels (‘‘Frequency per Disclosure’’ in 

table 1, row 1) for a total of 100 labels 

that include the information set forth in 

section III.A.11 of the draft guidance 

(including directions for use) (‘‘Total 

Disclosures’’ in table 1, row 1). We also 

estimate that designing, testing, and 

producing each label will take 

approximately 0.5 hours for each 

repackaged drug product (‘‘Hours per 

Disclosure’’ in table 1, row 1). The 

provision to add the statement http://

www.fda.gov/medwatch and 1–800– 

FDA–1088 is not included in this 

burden estimate because it is not 

considered a collection of information 

under the PRA because the information 

is ‘‘originally supplied by the Federal 

Government to the recipient for the 

purpose of disclosure to the public’’ (5 

CFR 1320.3(c)(2)). 

We also estimate that annually a total 

of approximately 10 outsourcing 

facilities (‘‘Number of Respondents’’ in 

table 1, row 2) will each produce a copy 

of prescribing information as set forth in 

section III.A.11 of the draft guidance for 

approximately 10 repackaged drug 

products (‘‘Frequency per Disclosure’’ 

in table 1, row 1) for a total of 100 

disclosures (‘‘total disclosures’’ in table 

1, row 2). We also estimate that 

providing prescribing information 

labeling will take approximately 1 hour 

for each repackaged drug product 

(‘‘Hours per Disclosure’’ in table 1, row 

2). The provision to add http://

www.fda.gov/medwatch and 1–800– 

FDA–1088 is not included in this 

burden estimate because it is not 

considered a collection of information 

under the PRA because the information 

is ‘‘originally supplied by the Federal 

Government to the recipient for the 

purpose of disclosure to the public’’ (5 

CFR 1320.3(c)(2)). 

The total estimated third-party 

disclosure burden resulting from the 

draft guidance is as follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN

Repackaging by outsourcing facilities Number of 

respondents 

Frequency per 

disclosure 

Total 

disclosures 

Hours per 

disclosure Total hours 

Designing, testing, and producing each label on immediate 

containers, packages and/or outer containers ................. 10 10 100 .5 50 

Prescribing information labeling produced for each repackaged drug product ............................................................ 10 10 100 1 100 

Total .............................................................................. ........................ ........................ ........................ ........................ 150 

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

*(30 minutes) 

The draft guidance also references 

registration, product reporting, and 

CGMP requirements for outsourcing 

facilities. In the Federal Register of 

December 4, 2013 (78 FR 72899), FDA 

estimated the burden resulting from 

outsourcing facility registration. In the 

Federal Register of December 4, 2013 

(78 FR 72897), FDA estimated the 

burden resulting from outsourcing 

facility interim product reporting. In the 

Federal Register of July 2, 2014 (79 FR 

37743), FDA estimated the burden 

resulting from outsourcing facility 

compliance with CGMP requirements. 

V. Electronic Access 

Persons with access to the Internet 

can obtain the document at either http:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 

Dated: February 11, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03417 Filed 2–18–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request; Health Information 

National Trends Survey (HINTS) (NCI) 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institutes of Health (NIH), has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 


emcdonald on DSK67QTVN1PROD with NOTICES