83 FR 2792 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 13 (January 19, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 13 (January 19, 2018)
| Page Range | 2792-2794 | |
| FR Document | 2018-00917 |
[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)] [Notices] [Pages 2792-2794] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-00917] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1309] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by February 20, 2018. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910--NEW and title ``Guidance for Industry on Compounded Drug Products that are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act.'' Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Guidance for Industry on Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act OMB Control Number 0910--NEW This information collection supports the above captioned Agency guidance document. In the Federal Register of July 11, 2016 (81 FR 44881), FDA announced the availability of a draft guidance for industry entitled ``Guidance for Industry on Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act,'' and included an analysis of the associated information collection. Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353a) describes conditions that must be met in order for compounded drugs to receive exemptions from certain sections of the FD&C Act, including section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice for drugs); section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with [[Page 2793]] adequate directions for use) and section 505 (21 U.S.C. 355) (concerning the approval of human drug products under new drug applications or abbreviated new drug applications). One condition of section 503A is that a compounder ``does not compound regularly or in inordinate amounts (as defined by the Secretary) any drug products that are essentially copies of a commercially available drug product'' (section 503A(b)(1)(D)). However, for the purposes of this section, ``essentially a copy of a commercially available drug product'' does not include a drug product ``in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug product'' (section 503A(b)(2)). The draft guidance states that if a compounder intends to rely on such a determination to establish that a compounded drug is not essentially a copy of a commercially available drug product, the compounder should ensure that the determination is documented on a prescription. If a prescription does not make clear that the prescriber made the determination required by section 503A(b)(2), or a compounded drug is substituted for the commercially available product at the pharmacy, the compounder may contact the prescriber and if the prescriber confirms it, make a notation on the prescription that the compounded product contains a change that makes a significant difference for the patient. The notations should be as specific as those described in this document, and the date of the conversation with the prescriber should be included on the prescription. In addition, if the drug was compounded because the approved product was not commercially available because it was on the FDA drug shortage list, the prescription or a notation on the prescription should note that it was on the drug shortage list and the date the list was checked. Finally, compounders under section 503A should maintain records of the frequency in which they have compounded drug products that are essentially copies of commercially available drug products and the number of prescriptions that they have filled for compounded drug products that are essentially copies of commercially available drug products to document that such compounding has not been done ``regularly'' or in ``inordinate amounts.'' FDA received 88 comments on the draft guidance, several of which raised issues pertaining to the information collection provisions in the draft guidance. The issues raised are addressed below. Issue One: One commenter proposed that any compounded drug with the same Active Pharmaceutical Ingredient (API) as a commercially available drug product should be considered to be ``essentially a copy'' of the commercially available drug product. FDA Response to Issue One: FDA has not made this proposed change. A compounded drug with the same API as a commercially available drug product may be very different from that commercially available drug product. For example, it may have a different route of administration and a substantially different strength. In such cases, a prescriber determination is not needed because the compounded drug would not be considered to be ``essentially a copy'' of the commercially available drug product, even if it had the same API. Issue Two: Several individuals submitted comments requesting the collection of additional information than what was proposed in the draft guidance.One commenter requested that the medical record maintained by the prescriber should include additional scientific rationale for prescribing the compounded product. Another commenter requested documentation to justify the use of a bulk drug substance to compound a product that could have been made starting with FDA-approved products. FDA Response to Issue Two: Regarding the first comment, this recommendation regarding what information a prescriber should maintain is outside the scope of this guidance. Regarding the second comment, the proposal is beyond the scope of the current guidance and we express no opinion on the proposed analysis and documentation. Issue Three: Several individuals submitted comments regarding collection of the prescriber determination in the hospital setting. Some commenters noted the prescriber determination is not necessary in the hospital setting because pharmacists often determine when a compounded drug is needed for a patient and not the prescriber. For example, one commenter noted that hospitals may have standing policies that specify use of compounded drugs in certain scenarios. Other commenters suggested use of a template or ``blanket'' prescriber determination statement when certain drugs are needed for a patient population on a consistent basis. Another commenter noted that State scope of practice acts or hospital policy may prohibit pharmacists from writing in the patient chart or altering the electronic health record. FDA Response to Issue Three: FDA is considering the applicability of the policies described in this guidance to hospitals and health systems and intends to address these issues in separate guidance. Issue Four: Several individuals commented that it would be burdensome to document the prescriber determination, as well as to call a prescriber to document a prescriber determination when such determination is not evident on the original prescription. Individuals felt a prescriber determination should not be necessary in certain cases, such as when a prescription indicates a compounded drug. FDA Response to Issue Four: Section 503A(b)(2) provides that a compounded drug is not essentially a copy of a commercially available drug product if there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug. If a prescription already documents the prescriber's determination of significant difference, there is no additional documentation burden for the compounder. However, if a prescription does not make clear that the prescriber made the determination required by section 503A(d)(2), or a compounded drug is substituted for the commercially available product at the pharmacy, the compounder may contact the prescriber, and if the prescriber confirms it, make a notation on the prescription that the compounded product contains a change that makes a significant difference for the patient. FDA estimates this contact will take 3 minutes and should not present significant burden. Maintaining prescription records that may include such notations should not present any additional burden, as FDA understands that maintaining records of prescriptions for compounded drug products is part of the usual course of the practice of compounding and selling drugs and is required by States' pharmacy laws and other State laws governing recordkeeping by health care professionals and health care facilities. Finally, FDA notes that calling a prescriber to document a prescriber determination of significant difference is not a requirement. For example, the [[Page 2794]] compounder has the option of not filling a prescription with a compounded drug if a prescriber determination is not provided. Issue Five: One commenter stated that requiring a notation on the prescription that a compounded drug was on the drug shortage list when compounded, and the date the list was checked, would be overly burdensome. FDA Response to Issue Five: FDA does not believe this presents a significant burden, as a compounder that wants to rely on a drug shortage to establish that a compounded drug is not essentially a copy of a commercially available drug would need to check FDA's shortage website. Noting the date the list was checked is not onerous, and is necessary for FDA to verify compliance during inspections. FDA estimates this activity would take 2 minutes. Issue Six: One commenter requested clarity on how long records should be maintained; what specific information should be maintained; and when such records should be presented to FDA. FDA Response to Issue Six: FDA has revised the guidance to include a recommended duration of 3 years for maintaining records. The guidance describes the records that can be retained to demonstrate compliance. FDA may request to review such records during establishment inspections. FDA estimates the burden of this collection of information as follows: We estimate that annually a total of approximately 6,888 compounders (``number of respondents'' in table 1, line 1) will consult a prescriber to determine whether he or she has made a determination that the compounded drug has a change that produces a significant difference for a patient as compared to the comparable commercially available drug, and that the compounders will document this determination on approximately 172,200 prescription orders for compounded drugs (``total annual disclosures'' in table 1, line 1). We estimate that the consultation between the compounder and the prescriber and adding a notation to each prescription that does not already document this determination will take approximately 3 minutes per prescription order. In addition, we estimate that a total of approximately 6,888 compounders (``number of respondents'' in table 1, line 2) will document this information on approximately 344,400 prescription orders for compounded drugs (``total annual disclosures'' in table 1, line 2). We estimate that checking FDA's drug shortage list and documenting this information will take approximately 2 minutes per prescription order. We estimate that a total of approximately 3,444 compounders (``number of recordkeepers'' in table 2) will keep approximately 165,312 records (``total annual records''). We estimate that maintaining the records will take approximately 2 minutes per record. Table 1--Estimated Annual Third Party Disclosure Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Type of reporting Number of disclosures Total annual Average burden per disclosure Total hours respondents per respondent disclosures -------------------------------------------------------------------------------------------------------------------------------------------------------- Consultation between the compounder and 6,888 50 344,400 0.05 (3 minutes).......................... 17,220 prescriber and the notation on the prescription documenting the prescriber's determination of significant difference. Checking FDA's drug shortage list and 6,888 50 344,400 0.03 (2 minutes).......................... 10,332 documenting on the prescription that the drug is in shortage. ----------------------------------------------------------------------------------------------------------- Total................................... .............. .............. .............. .......................................... 27,552 -------------------------------------------------------------------------------------------------------------------------------------------------------- \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 recordkeeping Number of records per Total annual Average burden per recordkeeping Total hours recordkeepers recordkeeper records -------------------------------------------------------------------------------------------------------------------------------------------------------- Records of frequency and number of 3,444 48 165,312 0.03 (2 minutes).......................... 4,959 prescriptions filled for compounded drugs that are essentially a copy. -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: January 16, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-00917 Filed 1-18-18; 8:45 am] BILLING CODE 4164-01-P
![2792 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices
In the Federal Register of July 11, conduct or sponsor. ‘‘Collection of (OMB) for review and clearance under
2016 (81 FR 44881), FDA issued a notice information’’ is defined in 44 U.S.C. the Paperwork Reduction Act of 1995.
announcing the availability of the draft 3502(3) and 5 CFR 1320.3 and includes DATES: Fax written comments on the
version of this guidance. The comment Agency requests or requirements that collection of information by February
period on the draft guidance ended on members of the public submit reports, 20, 2018.
October 11, 2016. FDA received keep records, or provide information to ADDRESSES: To ensure that comments on
approximately 88 comments on the draft a third party. Section 3506(c)(2)(A) of the information collection are received,
guidance. In response to received the PRA (44 U.S.C. 3506(c)(2)(A)) OMB recommends that written
comments or on its own initiative, FDA requires Federal Agencies to provide a comments be faxed to the Office of
made several changes. For example, in 60-day notice in the Federal Register Information and Regulatory Affairs,
response to requests in comments for concerning each proposed collection of OMB, Attn: FDA Desk Officer, Fax: 202–
direction on records retention, FDA information before submitting the 395–7285, or emailed to oira_
added a recommendation that collection to OMB for approval. To submission@omb.eop.gov. All
compounders maintain the records comply with this requirement, in the
comments should be identified with the
described in the guidance for a period Federal Register of July 11, 2016, we
OMB control number 0910—NEW and
of at least 3 years. In addition, to gave interested persons 60 days to
title ‘‘Guidance for Industry on
address questions raised in comments, comment on the information collection
Compounded Drug Products that are
FDA clarified that the policies in this provisions in the draft guidance (81 FR
Essentially Copies of a Commercially
guidance apply to a compounded drug 44881).
The information collection provisions Available Drug Product Under Section
product without regard to the source(s)
in this guidance have been submitted to 503A of the Federal Food, Drug, and
of the active pharmaceutical ingredient
OMB for review as required by section Cosmetic Act.’’ Also include the FDA
(API) in that product, for example, the
3507(d) of the PRA. These provisions docket number found in brackets in the
policies would apply regardless of
are not in effect until they display a heading of this document.
whether the compounder used an API
that was purchased as an isolate, or if currently valid OMB control number. FOR FURTHER INFORMATION CONTACT:
the compounder modified a finished FDA will publish a notice in the Federal Domini Bean, Office of Operations,
drug product containing an API. Register announcing OMB’s decision Food and Drug Administration, Three
FDA received comments on the draft regarding the information collection White Flint North, 10A–12M, 11601
guidance from hospital organizations provisions in this guidance. Landsdown St., North Bethesda, MD
regarding the potential implications of 20852, 301–796–5733, PRAStaff@
III. Electronic Access fda.hhs.gov.
the proposed policies in the draft
guidance for the preparation of Persons with access to the internet SUPPLEMENTARY INFORMATION: In
compounded drugs used in in-patient may obtain the guidance at either compliance with 44 U.S.C. 3507, FDA
settings. The final guidance notes that https://www.fda.gov/Drugs/ has submitted the following proposed
FDA is considering the applicability of GuidanceComplianceRegulatory collection of information to OMB for
the policies described in this guidance Information/Guidances/default.htm or review and clearance.
to hospitals and health systems. We https://www.regulations.gov.
recognize that this issue is of interest to Dated: January 16, 2018.
Guidance for Industry on Compounded
many stakeholders and will convey our Drug Products That Are Essentially
Leslie Kux,
further thinking on the applicability of Copies of a Commercially Available
Associate Commissioner for Policy.
these policies to hospitals and health Drug Product Under Section 503A of
[FR Doc. 2018–00915 Filed 1–18–18; 8:45 am] the Federal Food, Drug, and Cosmetic
systems publicly with an opportunity
BILLING CODE 4164–01–P Act
for comment.
This guidance is being issued OMB Control Number 0910—NEW
consistent with FDA’s good guidance
DEPARTMENT OF HEALTH AND This information collection supports
practices regulation (21 CFR 10.115).
HUMAN SERVICES the above captioned Agency guidance
This guidance represents the current
thinking of FDA on ‘‘Compounded Drug document. In the Federal Register of
Food and Drug Administration
Products That Are Essentially Copies of July 11, 2016 (81 FR 44881), FDA
a Commercially Available Drug Product [Docket No. FDA–2016–D–1309] announced the availability of a draft
Under Section 503A of the Federal guidance for industry entitled
Agency Information Collection ‘‘Guidance for Industry on Compounded
Food, Drug, and Cosmetic Act.’’ It does
Activities; Submission for Office of Drug Products That Are Essentially
not establish any rights for any person
Management and Budget Review; Copies of a Commercially Available
and is not binding on FDA or the public.
Comment Request; Guidance for Drug Product Under Section 503A of the
You can use an alternative approach if
Industry on Compounded Drug Federal Food, Drug, and Cosmetic Act,’’
it satisfies the requirements of the
Products That Are Essentially Copies and included an analysis of the
applicable statutes and regulations. This
of a Commercially Available Drug associated information collection.
guidance is not subject to Executive
Product Under Section 503A of the Section 503A of the Federal Food,
Order 12866.
Federal Food, Drug, and Cosmetic Act Drug, and Cosmetic Act (FD&C Act) (21
II. Paperwork Reduction Act of 1995 U.S.C. 353a) describes conditions that
AGENCY: Food and Drug Administration,
This guidance contains collections of HHS. must be met in order for compounded
daltland on DSKBBV9HB2PROD with NOTICES
information that are subject to review by ACTION: Notice. drugs to receive exemptions from
the Office of Management and Budget certain sections of the FD&C Act,
(OMB) under the Paperwork Reduction SUMMARY: The Food and Drug including section 501(a)(2)(B) (21 U.S.C.
Act (PRA) of 1995 (44 U.S.C. 3501– Administration (FDA) is announcing 351(a)(2)(B)) (concerning current good
3520). Under the PRA, Federal Agencies that a proposed collection of manufacturing practice for drugs);
must obtain approval from OMB for information has been submitted to the section 502(f)(1) (21 U.S.C. 352(f)(1))
each collection of information they Office of Management and Budget (concerning the labeling of drugs with
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![2794 Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices
compounder has the option of not filling should be maintained; and when such disclosures’’ in table 1, line 1). We
a prescription with a compounded drug records should be presented to FDA. estimate that the consultation between
if a prescriber determination is not FDA Response to Issue Six: FDA has the compounder and the prescriber and
provided. revised the guidance to include a adding a notation to each prescription
Issue Five: One commenter stated that recommended duration of 3 years for that does not already document this
requiring a notation on the prescription maintaining records. The guidance determination will take approximately 3
that a compounded drug was on the describes the records that can be minutes per prescription order.
drug shortage list when compounded, retained to demonstrate compliance. In addition, we estimate that a total of
and the date the list was checked, FDA may request to review such records approximately 6,888 compounders
would be overly burdensome. during establishment inspections. (‘‘number of respondents’’ in table 1,
FDA Response to Issue Five: FDA FDA estimates the burden of this line 2) will document this information
does not believe this presents a collection of information as follows: on approximately 344,400 prescription
significant burden, as a compounder We estimate that annually a total of orders for compounded drugs (‘‘total
that wants to rely on a drug shortage to approximately 6,888 compounders annual disclosures’’ in table 1, line 2).
establish that a compounded drug is not (‘‘number of respondents’’ in table 1, We estimate that checking FDA’s drug
essentially a copy of a commercially line 1) will consult a prescriber to shortage list and documenting this
available drug would need to check determine whether he or she has made information will take approximately 2
FDA’s shortage website. Noting the date a determination that the compounded minutes per prescription order.
the list was checked is not onerous, and drug has a change that produces a We estimate that a total of
is necessary for FDA to verify significant difference for a patient as approximately 3,444 compounders
compliance during inspections. FDA compared to the comparable (‘‘number of recordkeepers’’ in table 2)
estimates this activity would take 2 commercially available drug, and that will keep approximately 165,312
minutes. the compounders will document this records (‘‘total annual records’’). We
Issue Six: One commenter requested determination on approximately estimate that maintaining the records
clarity on how long records should be 172,200 prescription orders for will take approximately 2 minutes per
maintained; what specific information compounded drugs (‘‘total annual record.
TABLE 1—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1
Number of
Number of disclosures Total annual Average burden per
Type of reporting Total hours
respondents per disclosures disclosure
respondent
Consultation between the compounder and pre- 6,888 50 344,400 0.05 (3 minutes) ....... 17,220
scriber and the notation on the prescription docu-
menting the prescriber’s determination of signifi-
cant difference.
Checking FDA’s drug shortage list and docu- 6,888 50 344,400 0.03 (2 minutes) ....... 10,332
menting on the prescription that the drug is in
shortage.
Total ................................................................... ........................ ........................ ........................ ................................... 27,552
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 Total annual Average burden per
Type of recordkeeping records per Total hours
recordkeepers records recordkeeping
recordkeeper
Records of frequency and number of prescriptions 3,444 48 165,312 0.03 (2 minutes) ....... 4,959
filled for compounded drugs that are essentially a
copy.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 16, 2018. DEPARTMENT OF HEALTH AND ACTION: Notice; establishment of a
Leslie Kux, HUMAN SERVICES public docket; request for comments.
Associate Commissioner for Policy.
Food and Drug Administration SUMMARY: The Food and Drug
[FR Doc. 2018–00917 Filed 1–18–18; 8:45 am]
BILLING CODE 4164–01–P
Administration (FDA) announces a
[Docket No. FDA–2018–N–0055] forthcoming public advisory committee
daltland on DSKBBV9HB2PROD with NOTICES
meeting of the Gastrointestinal Drugs
Gastrointestinal Drugs Advisory
Advisory Committee. The general
Committee; Notice of Meeting;
function of the committee is to provide
Establishment of a Public Docket;
advice and recommendations to FDA on
Request for Comments
regulatory issues. The meeting will be
AGENCY: Food and Drug Administration, open to the public. FDA is establishing
HHS.
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Document Created: 2018-01-19 02:42:55
Document Modified: 2018-01-19 02:42:55
| 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. | |
| Dates | Fax written comments on the collection of information by February 20, 2018. | |
| Contact | Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected] | |
| FR Citation | 83 FR 2792 |
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