81 FR 96008 - Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 250 (December 29, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 250 (December 29, 2016)
| Page Range | 96008-96009 | |
| FR Document | 2016-31607 |
[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)] [Notices] [Pages 96008-96009] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-31607] ----------------------------------------------------------------------- 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
![96008 Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices
tissue establishments for determining related to HCT/Ps. Topics discussed Dated: December 23, 2016.
HCT/P donor eligibility. These will include: (1) Estimating disease Leslie Kux,
requirements include the need to screen incidence and/or prevalence in the Associate Commissioner for Policy.
and test potential donors of HCT/Ps for potential HCT/P donor population, (2) [FR Doc. 2016–31628 Filed 12–28–16; 8:45 am]
relevant communicable disease agents assessing the potential transmissibility BILLING CODE 4164–01–P
and diseases (RCDADs). of a disease by HCT/Ps, and (3)
The regulations under part 1271, understanding the capabilities of
subpart C, list the following RCDADs for current screening and testing DEPARTMENT OF HEALTH AND
all cells and tissues: Human HUMAN SERVICES
methodologies. The workshop will also
immunodeficiency virus, types 1 and 2;
include discussion on how available
hepatitis B virus; hepatitis C virus; Food and Drug Administration
human transmissible spongiform information can be used to characterize
the overall infectious disease risks [Docket No. FDA–2016–D–0269]
encephalopathy; and Treponema
pallidum. These regulations also list posed by HCT/Ps.
Prescription Requirement Under
human T-lymphotropic virus type I and III. Participating in the Public Section 503A of the Federal Food,
type II as RCDADs for viable, leukocyte- Workshop Drug, and Cosmetic Act; Guidance for
rich cells and tissues. For reproductive Industry; Availability
cells or tissues, a disease agent or Registration: To register for the public
disease of the genitourinary tract workshop, please visit the following AGENCY: Food and Drug Administration,
includes Chlamydia trachomatis and Web site at https://www.eventbrite.com/ HHS.
Neisseria gonorrhea. In addition, the e/identification-and-characterization-of- ACTION: Notice of availability.
regulations under part 1271, subpart C, hctp-infectious-disease-risks-public-
recognize that over time as new SUMMARY: The Food and Drug
workshop-registration-24465329459. Administration (FDA or the Agency) is
infectious diseases emerge there would Please provide complete contact
be the need to designate additional announcing the availability of a final
information for each attendee, including guidance for industry entitled
RCDADs. The regulations describe the
name, title, affiliation, address, email, ‘‘Prescription Requirement Under
criteria for identifying new RCDADs.
and telephone. Section 503A of the Federal Food, Drug,
These criteria include that the disease or
disease agent is potentially Registration is free and based on and Cosmetic Act.’’ This guidance sets
transmissible by a HCT/P: Either it has space availability, with priority given to forth FDA’s policy concerning certain
sufficient incidence and/or prevalence early registrants. Persons interested in prescription requirements for
to affect the donor population; or if it attending this public workshop must compounding human drug products for
were released in a manner to place register by February 6, 2017. Early identified individual patients under
potential donors at risk that it could be registration is recommended because section 503A of the Federal Food, Drug,
fatal or life-threatening, and that there seating is limited; therefore, FDA may and Cosmetic Act (the FD&C Act). It
were appropriate screening and legally addresses compounding after the receipt
limit the number of participants from
marketed screening tests available for it. of a prescription for an identified
each organization. Registrants will
However, the regulations under part individual patient, compounding before
receive confirmation once they have
1271, subpart C, do not specify the the receipt of a prescription for an
been accepted. Attendance for this
deliberative and scientific processes identified individual patient
workshop is in-person only. FDA will (anticipatory compounding), and
necessary to apply the criteria. post the agenda approximately 5 days
This workshop will describe currently compounding for office use.
before the workshop at http://
available scientific methods to DATES: Submit electronic or written
www.fda.gov/BiologicsBloodVaccines/
characterize both epidemiologic and comments on Agency guidances at any
NewsEvents/ time.
biological features of emerging diseases
WorkshopsMeetingsConferences/
and disease agents, and discuss their ADDRESSES: You may submit comments
potential use in evaluating HCT/P ucm490175.htm.
as follows:
infectious diseases risks for the purpose If you need special accommodations
of identifying new RCDADs for the because of disability, please contact Electronic Submissions
purposes of the HCT/P regulatory Monica Kapoor or Stacey Rivette no Submit electronic comments in the
framework. Assessing the overall risk of later than 7 days in advance of the following way:
a particular disease agent or disease to meeting by email at CBERPublicEvents@ • Federal eRulemaking Portal:
recipients of HCT/Ps requires fda.hhs.gov with the subject line titled https://www.regulations.gov. Follow the
consideration of multiple factors, ‘‘HCT/P Workshop.’’ instructions for submitting comments.
including the presence of the disease Comments submitted electronically,
Transcripts: Please be advised that as including attachments, to https://
agent or disease in the HCT/P donor soon as a transcript of the public
population, potential for transmission www.regulations.gov will be posted to
workshop is available, it will be the docket unchanged. Because your
by an HCT/P, and the potential
accessible at https:// comment will be made public, you are
morbidity or mortality in the recipient.
www.regulations.gov. It may be viewed solely responsible for ensuring that your
In many cases, information for one or
at the Division of Dockets Management comment does not include any
asabaliauskas on DSK3SPTVN1PROD with NOTICES
more of these factors may be limited or
incomplete. (HFA–305), Food and Drug confidential information that you or a
Administration, 5630 Fishers Lane, Rm. third party may not wish to be posted,
II. Topics for Discussion at the Public 1061, Rockville, MD 20852. A link to such as medical information, your or
Workshop the transcript will also be available on anyone else’s Social Security number, or
The workshop is intended as a the Internet at http://www.fda.gov/ confidential business information, such
scientific discussion regarding the BiologicsBloodVaccines/NewsEvents/ as a manufacturing process. Please note
current methods available to identify WorkshopsMeetingsConferences/ that if you include your name, contact
and characterize infectious disease risks ucm525001.html. information, or other information that
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![Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices 96009
identifies you in the body of your accordance with 21 CFR 10.20 and other section 503A of the FD&C Act only if it
comments, that information will be applicable disclosure law. For more is, among other things, compounded for
posted on https://www.regulations.gov. information about FDA’s posting of an identified individual patient based
• If you want to submit a comment comments to public dockets, see 80 FR on the receipt of a valid prescription
with confidential information that you 56469, September 18, 2015, or access order or a notation, approved by the
do not wish to be made available to the the information at: http://www.fda.gov/ prescribing practitioner, on the
public, submit the comment as a regulatoryinformation/dockets/ prescription order that a compounded
written/paper submission and in the default.htm. product is necessary for the identified
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to patient. Among other conditions, to
Submissions’’ and ‘‘Instructions’’). read background documents or the qualify for the exemptions under section
electronic and written/paper comments 503A, the drug product must be
Written/Paper Submissions
received, go to https:// compounded by a licensed pharmacist
Submit written/paper submissions as www.regulations.gov and insert the in a State-licensed pharmacy or a
follows: docket number, found in brackets in the Federal facility, or by a licensed
• Mail/Hand delivery/Courier (for heading of this document, into the physician (section 503A(a) of the FD&C
written/paper submissions): Division of ‘‘Search’’ box and follow the prompts Act).
Dockets Management (HFA–305), Food and/or go to the Division of Dockets This guidance sets forth FDA’s policy
and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm. concerning certain prescription
Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852. requirements for compounding human
• For written/paper comments Submit written requests for single drug products for identified individual
submitted to the Division of Dockets copies of the guidance to the Division of patients under section 503A of the
Management, FDA will post your Drug Information, Center for Drug FD&C Act. It addresses compounding
comment, as well as any attachments, Evaluation and Research, Food and after the receipt of a prescription for an
except for information submitted, Drug Administration, 10001 New identified individual patient,
marked and identified, as confidential, Hampshire Ave., Hillandale Building, compounding before the receipt of a
if submitted as detailed in 4th Floor, Silver Spring, MD 20993–
‘‘Instructions.’’ prescription for an identified individual
0002. Send one self-addressed adhesive patient (anticipatory compounding), and
Instructions: All submissions received label to assist that office in processing
must include the Docket No. FDA– compounding for office use.
your requests. See the SUPPLEMENTARY In the Federal Register of April 18,
2016–D–0269 for ‘‘Prescription INFORMATION section for electronic
Requirement Under Section 503A of the 2016 (81 FR 22617), FDA issued a notice
access to the guidance document. announcing the availability of the draft
Federal Food, Drug, and Cosmetic Act.’’ FOR FURTHER INFORMATION CONTACT: Sara
Received comments will be placed in version of this guidance. The comment
Rothman, Center for Drug Evaluation period on the draft guidance ended on
the docket and, except for those and Research, Food and Drug
submitted as ‘‘Confidential July 18, 2016. FDA received 111
Administration, 10903 New Hampshire comments on the draft guidance. In
Submissions,’’ publicly viewable at Ave., Bldg. 51, Rm. 5197, Silver Spring,
https://www.regulations.gov or at the response to received comments, FDA
MD, 301–796–3110. made certain changes to the guidance to
Division of Dockets Management
SUPPLEMENTARY INFORMATION: clarify particular points. FDA also
between 9 a.m. and 4 p.m., Monday
through Friday. I. Background removed provisions concerning
• Confidential Submissions—To notations on prescriptions and
FDA is announcing the availability of recordkeeping. The Agency intends to
submit a comment with confidential a final guidance for industry entitled
information that you do not wish to be address these matters in future policy
‘‘Prescription Requirement Under documents.
made publicly available, submit your Section 503A of the Federal Food, Drug,
comments only as a written/paper This guidance is being issued
and Cosmetic Act.’’ Section 503A 21 consistent with FDA’s good guidance
submission. You should submit two U.S.C. 353a), added to the FD&C Act by
copies total. One copy will include the practices regulation (21 CFR 10.115).
the Food and Drug Administration The guidance represents the current
information you claim to be confidential Modernization Act in 1997, describes
with a heading or cover note that states thinking of FDA on the prescription
the conditions that must be satisfied for requirement under section 503A of the
‘‘THIS DOCUMENT CONTAINS human drug products compounded by a
CONFIDENTIAL INFORMATION.’’ The FD&C Act. It does not establish any
licensed pharmacist in a State-licensed rights for any person and is not binding
Agency will review this copy, including pharmacy or Federal facility, or by a
the claimed confidential information, in on FDA or the public. You can use an
licensed physician, to be exempt from alternative approach if it satisfies the
its consideration of comments. The the following three sections of the FD&C
second copy, which will have the requirements of the applicable statutes
Act: and regulations.
claimed confidential information • Section 501(a)(2)(B) (21 U.S.C.
redacted/blacked out, will be available 351(a)(2)(B)) (concerning current good II. Electronic Access
for public viewing and posted on manufacturing practice requirements); Persons with access to the Internet
https://www.regulations.gov. Submit • section 502(f)(1) (21 U.S.C. may obtain the guidance at either http://
both copies to the Division of Dockets 352(f)(1)) (concerning the labeling of www.fda.gov/Drugs/Guidance
Management. If you do not wish your
asabaliauskas on DSK3SPTVN1PROD with NOTICES
drugs with adequate directions for use); ComplianceRegulatoryInformation/
name and contact information to be and Guidances/default.htm or https://www.
made publicly available, you can • section 505 (21 U.S.C. 355) regulations.gov.
provide this information on the cover (concerning the approval of drugs under
sheet and not in the body of your Dated: December 23, 2016.
new drug applications (NDAs) or
comments and you must identify this abbreviated new drug applications Leslie Kux,
information as ‘‘confidential.’’ Any (ANDAs)). Associate Commissioner for Policy.
information marked as ‘‘confidential’’ A compounded drug product may be [FR Doc. 2016–31607 Filed 12–28–16; 8:45 am]
will not be disclosed except in eligible for the exemptions under BILLING CODE 4164–01–P
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Document Created: 2016-12-29 01:58:31
Document Modified: 2016-12-29 01:58:31
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit electronic or written comments on Agency guidances at any time. | |
| 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. | |
| FR Citation | 81 FR 96008 |
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