81 FR 22617 - Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 74 (April 18, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 74 (April 18, 2016)
| Page Range | 22617-22619 | |
| FR Document | 2016-08877 |
[Federal Register Volume 81, Number 74 (Monday, April 18, 2016)] [Notices] [Pages 22617-22619] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-08877] ----------------------------------------------------------------------- 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[Docket No. FDA-2016-D-0269] Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act.''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: 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work to finalize the guidance, submit either electronic or written comments on this draft guidance by July 18, 2016. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by May 18, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 http://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 http://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 http://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 [[Page 22618]] and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit comments on information collection issues to the Office of Management and Budget in the following ways: Fax to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to [email protected]. All comments should be identified with the title, ``Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Collection of Information.'' Submit written requests for single copies of the draft 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 draft guidance document. FOR FURTHER INFORMATION CONTACT: Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Room 5197, Silver Spring, MD, 301-796-3110. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft 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 of 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 of the FD&C Act, 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)). 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. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent 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. Paperwork Reduction Act Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information that they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 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, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the collection of information associated with this document, FDA invites comments on the following 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. Under the draft guidance, if it is not obvious from a prescription order that the prescription is for a compounded drug product, a compounder may consult with the prescriber to determine whether the patient needs a compounded drug and make an appropriate notation on the prescription order. To serve as a basis for compounding under section 503A of the FD&C Act, a notation must document the prescriber's determination that a compounded drug is necessary for the identified patient. FDA recommends using the following statement: Per [type of communication] with [name of prescriber] on [date], [name of prescriber] has advised that compounded [name of drug] is necessary for the treatment of [name of patient]. We estimate that annually a total of approximately 3,444 licensed pharmacists and licensed physicians (``number of respondents'' in table 1) will make a notation with this statement on approximately 172,200 prescription orders (``total annual disclosures'' in table 1). We estimate that the consultation between the compounder and the prescriber and adding the written statement to each prescription will take approximately 5 minutes per prescription order. In addition, the licensed pharmacist or licensed physician seeking to compound a drug product under section 503A should maintain records of valid prescription orders received for compounded drug products to demonstrate compliance with the prescription requirement in section 503A(a)(1) of the FD&C Act. For example, this includes records of valid prescription orders and of prescription orders bearing notations that the compounded drug product is necessary for the identified individual patient as described in section III.A of this guidance and section 503A(a) of the FD&C Act. Because the time, effort, and financial resources necessary to comply with this collection of information would be incurred by licensed pharmacists and licensed physicians in the normal course of their activities, it is excluded from the definition of [[Page 22619]] ``burden'' under 5 CFR 1320.3(b)(2). 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 record keeping by health care professionals and health care facilities. Under the guidance, licensed pharmacists and licensed physicians should also maintain records of the calculations performed to determine the limited quantities of drug products compounded before the receipt of valid prescription orders under the enforcement policy described in section III.B.2 of this guidance and section 503A(a)(2) of the FD&C Act. These records should clearly reflect the quantity of a particular drug product compounded in advance of receiving prescription orders for identified individual patients that the compounder has kept on hand as stock for distribution, and the basis for the quantity the compounder kept in stock. Under the enforcement policy described in section III.B.2 of this guidance, this would include the quantity of the drug product distributed under prescription orders for identified individual patients during the reference period that the licensed pharmacist or licensed physician selected (i.e., a 30-day period within the last year). We estimate that annually a total of approximately 10,332 licensed pharmacists and licensed physicians (``number of recordkeepers'' in table 2) will maintain approximately 103,320 records (``total annual records'' in table 2). We estimate that maintaining the records will take approximately 5 minutes per record. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Third-Party Disclosure Burden 1 ---------------------------------------------------------------------------------------------------------------- Number of Type of reporting Number of disclosures per Total annual Average burden per Total hours respondents respondent disclosures disclosure ---------------------------------------------------------------------------------------------------------------- Consultation between the 3,444 50 172,200 0.083 (5 minutes)... 14,350 licensed pharmacist or licensed physician and the prescriber and adding a notation to document the prescriber's determination that a compounded drug is necessary for an identified patient. ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2--Estimated Annual Recordkeeping Burden 1 ---------------------------------------------------------------------------------------------------------------- Number of Type of reporting Number of records per Total annual Average burden per Total hours recordkeepers recordkeeper records recordkeeping ---------------------------------------------------------------------------------------------------------------- Records of calculations 10,332 10 103,320 0.083 (5 minutes)... 8,610 performed to determine ``limited quantities''. ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. III. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: April 12, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-08877 Filed 4-15-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 74 / Monday, April 18, 2016 / Notices 22617
IV. Paperwork Reduction Act of 1995 announcing the availability of a draft Dockets Management (HFA–305), Food
This guidance refers to previously guidance for industry entitled and Drug Administration, 5630 Fishers
approved collections of information ‘‘Prescription Requirement Under Lane, Rm. 1061, Rockville, MD 20852.
found in FDA regulations. These Section 503A of the Federal Food, Drug, • For written/paper comments
collections of information are subject to and Cosmetic Act.’’ This guidance sets submitted to the Division of Dockets
review by the Office of Management and forth FDA’s policy concerning certain Management, FDA will post your
prescription requirements for comment, as well as any attachments,
Budget (OMB) under the Paperwork
compounding human drug products for except for information submitted,
Reduction Act of 1995 (44 U.S.C. 3501–
identified individual patients under marked and identified, as confidential,
3520). The collections of information in
section 503A of the Federal Food, Drug, if submitted as detailed in
21 CFR part 58 have been approved
and Cosmetic Act (the FD&C Act). It ‘‘Instructions.’’
under OMB control number 0910–0119; Instructions: All submissions received
the collections of information in 21 CFR addresses compounding after the receipt
of a prescription for an identified must include the Docket No. FDA–
parts 801 and 809 have been approved 2016–D–0269 for ‘‘Prescription
under OMB control number 0910–0485; individual patient, compounding before
the receipt of a prescription for an Requirement Under Section 503A of the
the collections of information in 21 CFR Federal Food, Drug, and Cosmetic Act.’’
identified individual patient
part 807, subpart E, have been approved Received comments will be placed in
(anticipatory compounding), and
under OMB control number 0910–0120; the docket and, except for those
compounding for office use.
the collections of information in 21 CFR submitted as ‘‘Confidential
part 812 have been approved under DATES: Although you can comment on
any guidance at any time (see 21 CFR Submissions,’’ publicly viewable at
OMB control number 0910–0078; the http://www.regulations.gov or at the
collections of information in 21 CFR 10.115(g)(5)), to ensure that the Agency
considers your comment on this draft Division of Dockets Management
part 814 have been approved under between 9 a.m. and 4 p.m., Monday
OMB control number 0910–0231; the guidance before it begins work to
finalize the guidance, submit either through Friday.
collections of information in the
electronic or written comments on this • Confidential Submissions—To
guidance document entitled ‘‘Informed submit a comment with confidential
Consent For In Vitro Diagnostic Device draft guidance by July 18, 2016. Submit
comments on information collection information that you do not wish to be
Studies Using Leftover Human made publicly available, submit your
issues under the Paperwork Reduction
Specimens That Are Not Individually comments only as a written/paper
Act of 1995 by May 18, 2016.
Identifiable’’ have been approved under submission. You should submit two
OMB control number 0910–0582; the ADDRESSES: You may submit comments
copies total. One copy will include the
collections of information in the as follows:
information you claim to be confidential
guidance document entitled ‘‘Guidance Electronic Submissions with a heading or cover note that states
for Industry and FDA Staff: Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
Administrative Procedures for CLIA following way: CONFIDENTIAL INFORMATION.’’ The
Categorization’’ have been approved • Federal eRulemaking Portal: http:// Agency will review this copy, including
under OMB control number 0910–0607; www.regulations.gov. Follow the the claimed confidential information, in
and the collections of information in the instructions for submitting comments. its consideration of comments. The
guidance document entitled ‘‘Requests Comments submitted electronically, second copy, which will have the
for Feedback on Medical Device including attachments, to http:// claimed confidential information
Submissions: The Pre-Submission www.regulations.gov will be posted to redacted/blacked out, will be available
Program and Meetings with Food and the docket unchanged. Because your for public viewing and posted on
Drug Administration Staff’’ have been comment will be made public, you are http://www.regulations.gov. Submit
approved under OMB control number solely responsible for ensuring that your both copies to the Division of Dockets
0910–0756. comment does not include any Management. If you do not wish your
Dated: April 12, 2016. confidential information that you or a name and contact information to be
Leslie Kux, third party may not wish to be posted, made publicly available, you can
such as medical information, your or provide this information on the cover
Associate Commissioner for Policy.
anyone else’s Social Security number, or sheet and not in the body of your
[FR Doc. 2016–08899 Filed 4–15–16; 8:45 am]
confidential business information, such comments and you must identify this
BILLING CODE 4164–01–P information as ‘‘confidential.’’ Any
as a manufacturing process. Please note
that if you include your name, contact information marked as ‘‘confidential’’
information, or other information that will not be disclosed except in
DEPARTMENT OF HEALTH AND accordance with 21 CFR 10.20 and other
HUMAN SERVICES identifies you in the body of your
comments, that information will be applicable disclosure law. For more
Food and Drug Administration posted on http://www.regulations.gov. information about FDA’s posting of
• If you want to submit a comment comments to public dockets, see 80 FR
[Docket No. FDA–2016–D–0269] with confidential information that you 56469, September 18, 2015, or access
do not wish to be made available to the the information at: http://www.fda.gov/
Prescription Requirement Under regulatoryinformation/dockets/
Section 503A of the Federal Food, public, submit the comment as a
written/paper submission and in the default.htm.
Drug, and Cosmetic Act; Draft
mstockstill on DSK4VPTVN1PROD with NOTICES
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Guidance for Industry; Availability read background documents or the
Submissions’’ and ‘‘Instructions’’).
AGENCY: Food and Drug Administration, electronic and written/paper comments
Written/Paper Submissions received, go to http://
HHS.
ACTION: Notice of availability. Submit written/paper submissions as www.regulations.gov and insert the
follows: docket number, found in brackets in the
SUMMARY: The Food and Drug • Mail/Hand delivery/Courier (for heading of this document, into the
Administration (FDA or the Agency) is written/paper submissions): Division of ‘‘Search’’ box and follow the prompts
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![22618 Federal Register / Vol. 81, No. 74 / Monday, April 18, 2016 / Notices
and/or go to the Division of Dockets an identified individual patient based (2) the accuracy of FDA’s estimate of the
Management, 5630 Fishers Lane, Rm. on the receipt of a valid prescription burden of the proposed collection of
1061, Rockville, MD 20852. order or a notation, approved by the information, including the validity of
Submit comments on information prescribing practitioner, on the the methodology and assumptions used;
collection issues to the Office of prescription order that a compounded (3) ways to enhance the quality, utility,
Management and Budget in the product is necessary for the identified and clarity of the information to be
following ways: patient. Among other conditions, to collected; and (4) ways to minimize the
• Fax to the Office of Information and qualify for the exemptions under section burden of the collection of information
Regulatory Affairs, OMB, Attn: FDA 503A of the FD&C Act, the drug product on respondents, including through the
Desk Officer, FAX: 202–395–7285, or must be compounded by a licensed use of automated collection techniques,
email to oira_submission@omb.eop.gov. pharmacist in a State-licensed pharmacy when appropriate, and other forms of
All comments should be identified with or a Federal facility, or by a licensed information technology.
the title, ‘‘Prescription Requirement physician (section 503A(a)). Under the draft guidance, if it is not
Under Section 503A of the Federal This guidance sets forth FDA’s policy obvious from a prescription order that
Food, Drug, and Cosmetic Act; concerning certain prescription the prescription is for a compounded
Collection of Information.’’ requirements for compounding human drug product, a compounder may
Submit written requests for single drug products for identified individual consult with the prescriber to determine
copies of the draft guidance to the patients under section 503A of the whether the patient needs a
Division of Drug Information, Center for FD&C Act. It addresses compounding compounded drug and make an
Drug Evaluation and Research, Food after the receipt of a prescription for an appropriate notation on the prescription
and Drug Administration, 10001 New identified individual patient, order. To serve as a basis for
Hampshire Ave., Hillandale Building, compounding before the receipt of a compounding under section 503A of the
4th Floor, Silver Spring, MD 20993– prescription for an identified individual FD&C Act, a notation must document
0002. Send one self-addressed adhesive patient (anticipatory compounding), and the prescriber’s determination that a
label to assist that office in processing compounding for office use. compounded drug is necessary for the
your requests. See the SUPPLEMENTARY This draft guidance is being issued identified patient. FDA recommends
INFORMATION section for electronic
consistent with FDA’s good guidance using the following statement:
access to the draft guidance document. practices regulation (21 CFR 10.115). Per [type of communication] with
The draft guidance, when finalized, will [name of prescriber] on [date], [name of
FOR FURTHER INFORMATION CONTACT: Sara
represent the current thinking of FDA prescriber] has advised that
Rothman, Center for Drug Evaluation on the prescription requirement under compounded [name of drug] is
and Research, Food and Drug section 503A of the FD&C Act. It does necessary for the treatment of [name of
Administration, 10903 New Hampshire not establish any rights for any person patient].
Ave., Bldg. 51, Room 5197, Silver and is not binding on FDA or the public. We estimate that annually a total of
Spring, MD, 301–796–3110. You can use an alternative approach if approximately 3,444 licensed
SUPPLEMENTARY INFORMATION: it satisfies the requirements of the pharmacists and licensed physicians
I. Background applicable statutes and regulations. (‘‘number of respondents’’ in table 1)
will make a notation with this statement
FDA is announcing the availability of II. Paperwork Reduction Act on approximately 172,200 prescription
a draft guidance for industry entitled Under the Paperwork Reduction Act orders (‘‘total annual disclosures’’ in
‘‘Prescription Requirement Under of 1995 (the PRA) (44 U.S.C. 3501– table 1). We estimate that the
Section 503A of the Federal Food, Drug, 3520), Federal Agencies must obtain consultation between the compounder
and Cosmetic Act.’’ Section 503A (21 approval from the Office of Management and the prescriber and adding the
U.S.C. 353a), added to the FD&C Act by and Budget (OMB) for each collection of written statement to each prescription
the Food and Drug Administration information that they conduct or will take approximately 5 minutes per
Modernization Act of 1997, describes sponsor. ‘‘Collection of information’’ is prescription order.
the conditions that must be satisfied for defined in 44 U.S.C. 3502(3) and 5 CFR In addition, the licensed pharmacist
human drug products compounded by a 1320.3(c) and includes Agency requests or licensed physician seeking to
licensed pharmacist in a State-licensed or requirements that members of the compound a drug product under section
pharmacy or Federal facility, or by a public submit reports, keep records, or 503A should maintain records of valid
licensed physician, to be exempt from provide information to a third party. prescription orders received for
the following three sections of the FD&C Section 3506(c)(2)(A) of the PRA (44 compounded drug products to
Act: U.S.C. 3506(c)(2)(A)) requires Federal demonstrate compliance with the
• Section 501(a)(2)(B) (21 U.S.C. Agencies to provide a 60-day notice in prescription requirement in section
351(a)(2)(B)) (concerning current good the Federal Register concerning each 503A(a)(1) of the FD&C Act. For
manufacturing practice requirements); proposed collection of information example, this includes records of valid
• section 502(f)(1) (21 U.S.C. before submitting the collection to OMB prescription orders and of prescription
352(f)(1)) (concerning the labeling of for approval. To comply with this orders bearing notations that the
drugs with adequate directions for use); requirement, FDA is publishing notice compounded drug product is necessary
and of the proposed collection of for the identified individual patient as
• section 505 (21 U.S.C. 355) information set forth in this document. described in section III.A of this
mstockstill on DSK4VPTVN1PROD with NOTICES
(concerning the approval of drugs under With respect to the collection of guidance and section 503A(a) of the
new drug applications (NDAs) or information associated with this FD&C Act. Because the time, effort, and
abbreviated new drug applications document, FDA invites comments on financial resources necessary to comply
(ANDAs)). the following topics: (1) Whether the with this collection of information
A compounded drug product may be proposed collection of information is would be incurred by licensed
eligible for the exemptions under necessary for the proper performance of pharmacists and licensed physicians in
section 503A of the FD&C Act only if it FDA’s functions, including whether the the normal course of their activities, it
is, among other things, compounded for information will have practical utility; is excluded from the definition of
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‘‘burden’’ under 5 CFR 1320.3(b)(2). prescription orders under the orders for identified individual patients
FDA understands that maintaining enforcement policy described in section during the reference period that the
records of prescriptions for III.B.2 of this guidance and section licensed pharmacist or licensed
compounded drug products is part of 503A(a)(2) of the FD&C Act. These physician selected (i.e., a 30-day period
the usual course of the practice of records should clearly reflect the within the last year).
compounding and selling drugs and is quantity of a particular drug product We estimate that annually a total of
required by States’ pharmacy laws and compounded in advance of receiving approximately 10,332 licensed
other State laws governing record prescription orders for identified pharmacists and licensed physicians
keeping by health care professionals and individual patients that the compounder (‘‘number of recordkeepers’’ in table 2)
health care facilities. has kept on hand as stock for will maintain approximately 103,320
Under the guidance, licensed distribution, and the basis for the records (‘‘total annual records’’ in table
pharmacists and licensed physicians quantity the compounder kept in stock. 2). We estimate that maintaining the
should also maintain records of the Under the enforcement policy described records will take approximately 5
calculations performed to determine the in section III.B.2 of this guidance, this minutes per record.
limited quantities of drug products would include the quantity of the drug FDA estimates the burden of this
compounded before the receipt of valid product distributed under prescription collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of Total annual
Type of reporting disclosures per burden per Total hours
respondents disclosures
respondent disclosure
Consultation between the licensed pharmacist or licensed 3,444 50 172,200 0.083 (5 min- 14,350
physician and the prescriber and adding a notation to doc- utes).
ument the prescriber’s determination that a compounded
drug is necessary for an identified patient.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Number of Average
Total annual
Type of reporting record- records per burden per Total hours
records
keepers recordkeeper recordkeeping
Records of calculations performed to determine ‘‘limited 10,332 10 103,320 0.083 (5 min- 8,610
quantities’’. utes).
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
III. Electronic Access ACTION: Notice. Spring, MD 20993–0002, PRAStaff@
Persons with access to the Internet fda.hhs.gov.
SUMMARY: The Food and Drug
may obtain the draft guidance at either Administration (FDA) is announcing SUPPLEMENTARY INFORMATION: In
http://www.fda.gov/Drugs/Guidance that a proposed collection of compliance with 44 U.S.C. 3507, FDA
ComplianceRegulatoryInformation/ information has been submitted to the has submitted the following proposed
Guidances/default.htm or http:// Office of Management and Budget collection of information to OMB for
www.regulations.gov. (OMB) for review and clearance under review and clearance.
Dated: April 12, 2016. the Paperwork Reduction Act of 1995. Inspection by Accredited Persons
Leslie Kux, DATES: Fax written comments on the Program Under the Medical Device
Associate Commissioner for Policy. collection of information by May 18, User Fee and Modernization Act of
[FR Doc. 2016–08877 Filed 4–15–16; 8:45 am] 2016. 2002—OMB Control Number 0910–
BILLING CODE 4164–01–P ADDRESSES: To ensure that comments on 0510—Extension
the information collection are received, The Medical Device User Fee and
OMB recommends that written Modernization Act of 2002 (MDUFMA)
DEPARTMENT OF HEALTH AND comments be faxed to the Office of
HUMAN SERVICES (Pub. L. 107–250) was signed into law
Information and Regulatory Affairs, on October 26, 2002. Section 201 of
OMB, Attn: FDA Desk Officer, FAX: MDUFMA added a new paragraph (g) to
Food and Drug Administration
202–395–7285, or emailed to oira_ section 704 of the Federal, Food, Drug,
[Docket No. FDA–2012–N–0427] submission@omb.eop.gov. All and Cosmetic Act (21 U.S.C. 374),
comments should be identified with the directing FDA to accredit third parties
Agency Information Collection OMB control number 0910–0510. Also
mstockstill on DSK4VPTVN1PROD with NOTICES
Activities; Submission for Office of (accredited persons) to conduct
include the FDA docket number found inspections of eligible manufacturers of
Management and Budget Review; in brackets in the heading of this
Comment Request; Medical Devices; class II or class III devices. FDA’s
document. guidance document entitled
Inspection by Accredited Persons
Program FOR FURTHER INFORMATION CONTACT: FDA ‘‘Implementation of the Inspection by
PRA Staff, Office of Operations, Food Accredited Persons Program Under the
AGENCY: Food and Drug Administration, and Drug Administration, 8455 Medical Device User Fee and
HHS. Colesville Rd., COLE–14526, Silver Modernization Act of 2002;
VerDate Sep<11>2014 17:54 Apr 15, 2016 Jkt 238001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\18APN1.SGM 18APN1](https://thefederalregister.org/doc/81_FR_22691/page/3.svg)
Document Created: 2016-04-16 01:46:16
Document Modified: 2016-04-16 01:46:16
| 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 | 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 to finalize the guidance, submit either electronic or written comments on this draft guidance by July 18, 2016. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by May 18, 2016. | |
| Contact | Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Room 5197, Silver Spring, MD, 301-796-3110. | |
| FR Citation | 81 FR 22617 |
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