Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability, 96008-96009 [2016-31607]

Download as PDF asabaliauskas on DSK3SPTVN1PROD with NOTICES 96008 Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices tissue establishments for determining HCT/P donor eligibility. These requirements include the need to screen and test potential donors of HCT/Ps for relevant communicable disease agents and diseases (RCDADs). The regulations under part 1271, subpart C, list the following RCDADs for all cells and tissues: Human immunodeficiency virus, types 1 and 2; hepatitis B virus; hepatitis C virus; human transmissible spongiform encephalopathy; and Treponema pallidum. These regulations also list human T-lymphotropic virus type I and type II as RCDADs for viable, leukocyterich cells and tissues. For reproductive cells or tissues, a disease agent or disease of the genitourinary tract includes Chlamydia trachomatis and Neisseria gonorrhea. In addition, the regulations under part 1271, subpart C, recognize that over time as new infectious diseases emerge there would be the need to designate additional RCDADs. The regulations describe the criteria for identifying new RCDADs. These criteria include that the disease or disease agent is potentially transmissible by a HCT/P: Either it has sufficient incidence and/or prevalence to affect the donor population; or if it were released in a manner to place potential donors at risk that it could be fatal or life-threatening, and that there were appropriate screening and legally marketed screening tests available for it. However, the regulations under part 1271, subpart C, do not specify the deliberative and scientific processes necessary to apply the criteria. This workshop will describe currently available scientific methods to characterize both epidemiologic and biological features of emerging diseases and disease agents, and discuss their potential use in evaluating HCT/P infectious diseases risks for the purpose of identifying new RCDADs for the purposes of the HCT/P regulatory framework. Assessing the overall risk of a particular disease agent or disease to recipients of HCT/Ps requires consideration of multiple factors, including the presence of the disease agent or disease in the HCT/P donor population, potential for transmission by an HCT/P, and the potential morbidity or mortality in the recipient. In many cases, information for one or more of these factors may be limited or incomplete. II. Topics for Discussion at the Public Workshop The workshop is intended as a scientific discussion regarding the current methods available to identify and characterize infectious disease risks VerDate Sep<11>2014 18:41 Dec 28, 2016 Jkt 241001 related to HCT/Ps. Topics discussed will include: (1) Estimating disease incidence and/or prevalence in the potential HCT/P donor population, (2) assessing the potential transmissibility of a disease by HCT/Ps, and (3) understanding the capabilities of current screening and testing methodologies. The workshop will also include discussion on how available information can be used to characterize the overall infectious disease risks posed by HCT/Ps. III. Participating in the Public Workshop Registration: To register for the public workshop, please visit the following Web site at https://www.eventbrite.com/ e/identification-and-characterization-ofhctp-infectious-disease-risks-publicworkshop-registration-24465329459. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by February 6, 2017. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation once they have been accepted. Attendance for this workshop is in-person only. FDA will post the agenda approximately 5 days before the workshop at http:// www.fda.gov/BiologicsBloodVaccines/ NewsEvents/ WorkshopsMeetingsConferences/ ucm490175.htm. If you need special accommodations because of disability, please contact Monica Kapoor or Stacey Rivette no later than 7 days in advance of the meeting by email at CBERPublicEvents@ fda.hhs.gov with the subject line titled ‘‘HCT/P Workshop.’’ Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https:// www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A link to the transcript will also be available on the Internet at http://www.fda.gov/ BiologicsBloodVaccines/NewsEvents/ WorkshopsMeetingsConferences/ ucm525001.html. PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 Dated: December 23, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–31628 Filed 12–28–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–D–0269] Prescription Requirement 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. The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled ‘‘Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act.’’ This guidance sets forth FDA’s policy concerning certain prescription requirements for compounding human drug products for identified individual patients under section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). It addresses compounding after the receipt of a prescription for an identified individual patient, compounding before the receipt of a prescription for an identified individual patient (anticipatory compounding), and compounding for office use. DATES: Submit electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comments as follows: SUMMARY: 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 E:\FR\FM\29DEN1.SGM 29DEN1 Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices asabaliauskas on DSK3SPTVN1PROD with NOTICES 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): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, 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–0269 for ‘‘Prescription Requirement 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 Division of Dockets Management 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 Division of Dockets Management. 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 VerDate Sep<11>2014 18:41 Dec 28, 2016 Jkt 241001 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: http://www.fda.gov/ regulatoryinformation/dockets/ default.htm. 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the 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, 301–796–3110. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a final guidance for industry entitled ‘‘Prescription Requirement 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 in 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)). A compounded drug product may be eligible for the exemptions under PO 00000 Frm 00054 Fmt 4703 Sfmt 9990 96009 section 503A of the FD&C Act only if it is, among other things, compounded for an identified individual patient based on the receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient. Among other conditions, to qualify for the exemptions under section 503A, the drug product must be compounded by a licensed pharmacist in a State-licensed pharmacy or a Federal facility, or by a licensed physician (section 503A(a) of the FD&C Act). This guidance sets forth FDA’s policy concerning certain prescription requirements for compounding human drug products for identified individual patients under section 503A of the FD&C Act. It addresses compounding after the receipt of a prescription for an identified individual patient, compounding before the receipt of a prescription for an identified individual patient (anticipatory compounding), and compounding for office use. In the Federal Register of April 18, 2016 (81 FR 22617), FDA issued a notice announcing the availability of the draft version of this guidance. The comment period on the draft guidance ended on July 18, 2016. FDA received 111 comments on the draft guidance. In response to received comments, FDA made certain changes to the guidance to clarify particular points. FDA also removed provisions concerning notations on prescriptions and recordkeeping. The Agency intends to address these matters in future policy documents. 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 the prescription requirement under section 503A of the FD&C 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. II. Electronic Access Persons with access to the Internet may obtain the guidance at either http:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https://www. regulations.gov. Dated: December 23, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–31607 Filed 12–28–16; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\29DEN1.SGM 29DEN1

Agencies

[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 96008-96009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31607]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0269]


Prescription Requirement 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 the Agency) is 
announcing the availability of a final guidance for industry entitled 
``Prescription Requirement Under Section 503A of the Federal Food, 
Drug, and Cosmetic Act.'' This guidance sets forth FDA's policy 
concerning certain prescription requirements for compounding human drug 
products for identified individual patients under section 503A of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act). It addresses 
compounding after the receipt of a prescription for an identified 
individual patient, compounding before the receipt of a prescription 
for an identified individual patient (anticipatory compounding), and 
compounding for office use.

DATES: Submit electronic or written comments on Agency guidances at any 
time.

ADDRESSES: 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

[[Page 96009]]

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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-0269 for ``Prescription Requirement 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 Division of Dockets Management 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 Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the 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, 301-796-3110.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Prescription Requirement 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 in 
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)).
    A compounded drug product may be eligible for the exemptions under 
section 503A of the FD&C Act only if it is, among other things, 
compounded for an identified individual patient based on the receipt of 
a valid prescription order or a notation, approved by the prescribing 
practitioner, on the prescription order that a compounded product is 
necessary for the identified patient. Among other conditions, to 
qualify for the exemptions under section 503A, the drug product must be 
compounded by a licensed pharmacist in a State-licensed pharmacy or a 
Federal facility, or by a licensed physician (section 503A(a) of the 
FD&C Act).
    This guidance sets forth FDA's policy concerning certain 
prescription requirements for compounding human drug products for 
identified individual patients under section 503A of the FD&C Act. It 
addresses compounding after the receipt of a prescription for an 
identified individual patient, compounding before the receipt of a 
prescription for an identified individual patient (anticipatory 
compounding), and compounding for office use.
    In the Federal Register of April 18, 2016 (81 FR 22617), FDA issued 
a notice announcing the availability of the draft version of this 
guidance. The comment period on the draft guidance ended on July 18, 
2016. FDA received 111 comments on the draft guidance. In response to 
received comments, FDA made certain changes to the guidance to clarify 
particular points. FDA also removed provisions concerning notations on 
prescriptions and recordkeeping. The Agency intends to address these 
matters in future policy documents.
    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 the prescription requirement under section 
503A of the FD&C 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.

II. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: December 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31607 Filed 12-28-16; 8:45 am]
BILLING CODE 4164-01-P