Document text
1 Date: August 20, 2021
From: Daphne D. Stewart, CSO
Regulatory Management Support Branch, DVRPA/OVRR
Through: Tim D. Nelle, Ph.D. , CAPT U.S. Public Health Service,
Branch Chief, RMSB
To: BLA STN 125742/0 File
Subject Review of BioNTech Manufacturing GmbH – BLS 125742/0
COVID- 19 mRNA Vaccine (nucleoside modified) – COMIRNATY ®
Carton and Container Labeling
Background
This Biologic License Application (BLA) is for COVID- 19 mRNA Vaccine
(nucleoside modified) – COMIRNATY® which is indicated for active immunization
to prevent COVID -19 disease caused by SARS -CoV- 2 in individuals 16 years of
age and older . This submission on contains the following labels that are the
subject of this review:
• Single -Dose 2 mL (25 Doses) Diluent Sodium Chloride Injection,
USP 0.9% Vial Carton Label – Fresenius Kabi
• Single -Dose 2 mL Diluent Sodium Chloride Injection,
USP 0.9% Vial Container Label – Fresenius Kabi
• Multiple -Dose 10 mL (25 Doses) Diluent 0.9% Sodium Chloride
Injection, USP Vial Carton Label – Hospira
• Single -Dose 10 mL Diluent Sodium Chloride Injection,
USP 0.9% Vial Container Label – Hospira
• Fresenius Kabi Diluent Stamp
• Hospira Diluent Sticker Label
• Multiple -Dose (25 Doses) Vial Carton Label –
Kalamazoo, MI and Puurs, Belgium
• Multiple -Dose (195 Doses) Vial Carton Label
Kalamazoo, MI and Puurs, Belgium
• Single -Dose 0.3 mL Vial Container Label –
Kalamazoo, MI and Puurs, Belgium
These labels were reviewed for compliance with the regulat ions 21 CFR 201.25
& 21 CFR 207.35, Subpart G – Labeling Standards 21 CFR 610.60 (a)(1)
through (7) and 21 CFR 610.60 (7) (b) through (e), 21 CFR 610.62 (a) through (c), 21 CFR 610.63, 21 CFR 610.64, 21 CFR 610.67, the Drug Supply Chain
Security Act (DSCSA) and CBER Job Aid 900.08: National Drug Code, Bar Code DEPARTMENT OF HEALTH & HUMAN SERVICES
FDA/CBER/OVRR/DVRPA
Memorandum
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1150288
2 and Product Identifier. To ensure completeness, the CBER checklists were used
during this review; however, only the checklists for the final draft labels are attached to this review (see Appendixes). In each checklist, an “x” next to each item denotes that the label was found to be compliant with the corresponding regulation.
Multiple -Dos
e 2 mL (25 Doses) Diluent 0.9% Sodium Chloride Injection, USP Vial
Carton Label – Fresenius Kabi (NDC 63323- 186-02):
The original carton label that was provided consisted of a container label
with the NDC stamped onto the carton. The agency requested that the applicant have separate labels for the carton and the container on
August 9, 2021. In response, th e applicant submitted a revised diluent
carton and a separate diluent container label on August 17, 2021, and
again on August 19, 2021. After review, it was determined that this
carton label is approvable. Please see Appendix 1 for full review.
Single -Dose 2 mL D
iluent Sodium Chloride Injection, USP 0.9% Vial Container
Label – Fresenius Kabi (NDC 63323 -186-04):
The applicant submitted this container label on August 17, 2021, and
again on August 19, 2021. This container label is approvable. Please
see Appendix 2 for full review.
Multiple -Dose 10 mL (25 Doses) Diluent 0.9% Sodium Chloride Injection, USP
Vial Car ton Label – Hospira (NDC 0409- 4888- 10)
The original label did not include t he diluent proper name, the product
identifier, the lot number, or expiration date. It also was identical to the vial
label. After being notified on August 9, 2021, t he applicant submitted a
revised label that addressed these deficiencies on August 13 , 2021;
August 17, 2021; and again on August 19, 2021. This label is acceptable
for approval. Please see A ppendix 3 for full review.
Single -Dose 10 mL Sterile Diluent Vial Container Label (NDC 0409 -4888
-02)
.
The applicant submitted a container label for their Diluent 0.9% Sodium Chloride Injection, USP Vial Carton Label – Hospira to
CBER on August 17, 2021, and again on August 19, 2021. This label is
acceptable for approval. Please see A ppendix 4 for full review.
Fresenius Kab
i Diluent Stamp (No NDC):
The original label did not include the diluent proper name, the product identifier, the lot number, or expiration date. After being notified of these
deficiencies on August 9, 2021, the applicant submitted a revised
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1150289
3 Fresenius Kabi diluent stamp to CBER on August 13 , 2021; and August
17, 2021. The applicant also attempted to submit a picture on August 19
but noted that they could not take a new picture of the stamp because the
entire packaging line would have to be shut down. CBER responded that
a picture wasn’t required – only the information/text that would be
included on the stamp is necessary is to submit at this time . The
applicant acknowledged this and confirmed that: “The stamp will be
updated so that it is alignment with the text included in the Diluent Sticker
for Hospira ( also provided in this submission).” This response was
deemed sufficient. This label is acceptable for approval. Please see
Appendix 5 for full review.
Hospira D iluent Sticker (Vial) Label (No NDC)
The original label did not include the diluent proper name, the product identifier, the lot number, or expiration date. After being notified of these
deficiencies on August 9, 2021, the applicant submitted a revised Hospira
diluent sticker to CBER on Augu st 13, 2021; August 17, 2021; and again,
on August 19, 2021. This label is acceptable for approval. Please see
Appendix 6 for full review.
Multiple -D
ose (25 Doses) Vial Carton Label (NDC 0069 -1000- 03) (both “Puurs” &
“Kzoo”)
The or
iginal label s did not include the Product Identifier, required by Drug
Supply Chain Security Act (DSCSA) or the license number . The applicant
was asked to address these deficiencies and r evise the proper name to
“COVID -19 Vaccine, mRNA ” on August 9, 2021. Also, th ere was internal
discussion about the placement of the QR Code and how it competes with,
distract s from, and interrupt s the carton label; however, it was decided no
further action would be required this matter. The applicant submitted their
revised labels for both locations to CBER on August 13, 2021; August 17,
2021; and again, on August 19, 2021. These label s are acceptable for
approval. Please see Appendix 7 for full review.
Multiple -D ose (195 Doses) Vial Carton Label (NDC 0069 -1000- 02) (both “Puurs”
& “Kzoo”)
The or
iginal labels did not include the Product Identifier, required by Drug
Supply Chain Security Act (DSCSA) or the license number. It was also
not clear what information would be printed in both fields of the “Overprint Area”. The applicant was asked to address these issues and revise the
proper name to “COVID -19 Vaccine, mRNA ” on August 9, 2021. Also,
there was internal discussion about the placement of the QR Code and how it competes with, distracts from, and interrupts the carton label; however, it was decided no further action would be required for this
FDA-CBER-2021-5683-1150290
4 matter. The applicant submitted their revised labels ( for both locations ) on
August 13, 2021; August 17, 2021, and again on August 19, 2021. These
label s are acceptable for approval. Please see Appendix 8 for full review.
Single -D ose 0.3 Vial Container Label (NDC 0069- 1000- 01) (both “Puurs” &
“Kzoo”)
The or
iginal labels did not include l icense number . After being notified of
this deficienc y and the need to revise the proper name to “COVID -19
Vaccine, mRNA” on August 9, 2021, the applicant submitted revised
labels for both location s on August 13, 2021, August 17, 2021, and again
on August 19, 2021. These label s are acceptable for approval. Please
see Appendix 9 for full review.
Recommendations
These labels are currently in compliance with 21 CFR 201.25, 21 CFR 207.35
and 21 CFR 610.60 through 21 CFR 610.67, Drug Supply Chain Security Act (DSCSA), the Guidance for Industry, “Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple- Dose, Single -Dose, and Single- Patient -Use Containers for
Human Use”, and CBER Job Aid 900.08: National Drug Code, Bar Code and Product Identifier. Therefore, these labels are recommended for approval.
FDA-CBER-2021-5683-1150291
5 Appendix 1: Review Checklist for Multiple -Dose 2 mL (25 Doses) Diluent 0.9% Sodium Chloride
Injection, USP Vial Carton Label: (Package) Label – Fresenius Kabi (NDC 63323- 186-02
submitted on August 17, 2021, and August 19, 2021.
21 CFR 610.61 (a) through (s ) Checked items “x”
indicate compliance
a. The proper name of the product; X
b. The name, address, and license number of manufacturer; X
c. The lot number or other lot identification; X
d. The expiration date; X
e. The preservative used and its concentration, or if no preservative
is used and the absence of a preservative is a safety factor, the words
“no preservative”; X
f. The number of containers, if more than one; X
g. The amount of product in the container expressed as
(1) the number of doses, (2) volume, (3) units of potency,
(4) weight, (5) equivalent volume (for dried product to be
reconstituted), or (6) such combination of the foregoing as
needed for an accurate description of the contents, whichever
is applicable; X
h. The recommended storage t emperature; X
i. The words “Shake Well”, “Do not Freeze” or the equivalent, as
well as other instructions, when indicated by the character of
the product; X
j. The recommended individual dose, for multiple dose
containers. 25 Doses
k. The route of administration recommended, or reference to
such directions in an enclosed circular X
l. Known sensitizing substances, or reference to an enclosed
circular containing appropriate information; X
m. The type and calculated amount of antibiotics added during
manufacture; X
n. The inactive ingredients when a safety factor, or ref erence to an
enclosed circular containing appropriate information; X
o. The adjuvant, if present; N/A
p. The source of the product when a factor in safe administration; X
q. The identity of each microorganism used in manufacture, and,
where applicable, the production medium and the method of
inactivation, or reference to an enclosed circular containing
appropriate information X
r. Minimum potency of pr oduct expressed in terms of official
standard of potency or, if potency is a factor and no U.S.
standard of potency has been prescribed, the words “No U.S.
standard of potency.” X
s. The statement: “‘Rx only’” for prescription biologicals. X
FDA-CBER-2021-5683-1150292
6 Page 2 – Label Review (Package) appendix 1
JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21
CFR 207.35 (3)(i) Checked items “x”
indicate compliance
9. Barcode & Linear or One -Dimensional (1D) (Parallel Lines)
NDC
a. Using the website
https://www.fda.gov/industry/structured -pr oduct -labeling -
resources/ndcnhric -labeler -codes
(to check the sponsor’s NDC)
b. Click “Open”
c. Click “ndc_hric_labeler_codes”
d. Click “Yes”
e. Locate the Firm Name and the NDC Labeler
Code will be to the right
X
X
X
X X
X
10. Detachable Portion
If the detachable label has a 2D Barcode, then
you need to follow steps #8 & steps #9
(Barcode & NDC/2D Barcode)
The actual detach label needs to include:
a. Proprietary Name
b. NDC #
c. Lot # & Expiry Date N/A
If the detachable label cannot contain all the above information, then it should
have:
a. Proprietary Name
b. NDC #
c. Lot #
For 2D Barcodes on the carton label to meet the regulations for the Drug
Supply Chain Sec urity Act (DSCSA).
Product Identifier - 2D Barcode
a. Locate the symbol and the datamatrix codes will
consist of:
NDC (01):
EXPIRY (17):
BATCH/LOT (10):
SERIAL (21):
N/A
X
X X
X
X
FDA-CBER-2021-5683-1150293
7 Page 3 – Label Review (Package) appendix 1
Selection of the Appropriate Package Type Terms and Recommendations
for Labeling Injectable Medical Products Packaged in Multiple -Dose,
Single -Dose, and Single- Patient -Use Containers for Human Use Guidance
for Industry Checked items “x”
indicate compliance
a. Multiple -Dose
b. Single-Dose
c. Single -Patient -Use x
11. If there is an age range associated with the label is should be included
on the label. The placement should not be on the detachable portion.
16 years of age and older
Comments:
Diluent 0.9% Sodium Chloride Injection, USP Vial Carton Label – Fresenius Kabi
This label is acceptable for approval.
FDA-CBER-2021-5683-1150294
8 Appendix 2: Review Checklist for Single -Dose 2 mL Diluent Sodium Chloride Injection, USP
0.9% Vial Container Label – Fresenius Kabi (NDC 63323 -186-04) submitted on August 17, 2021,
and August 19, 2021.
21 CFR 610.60(a)(1) through (7) Checked items “x”
indicate compliance
a. Full label. The following items shall appear on the label affixed to each
container of a product capable of bearing a full label:
X
* 1. The proper name of the product; X
* 2. The name, address, and license number of
manufacturer; X
* 3. The lot number or other lot identification; X
* 4. The expiration date; X
* 5. The recommended individual dose, for multiple dose
containers. 2 mL
* 6. The statement: “‘Rx only’” for prescription biologicals. X
7. If a Medication Guide is required under part 208 of this
chapter, the statement required under §208.24(d) of
this chapter instructing the authorized dispenser to
provide a Medication Guide to each patient to whom
the drug is dispensed and stating how the Medication
Guide is provided, except where the container label is
too small, the required statement may be placed on
the package label.
N/A
21 CFR 610.62 (7) (b) through (e) Checked items “x”
indicate compliance
b. Package label information. If the container is not enclosed
in a package, all the items required for a package label
shall appear on the container label.
N/A
c. Partial label. If the container is capable of bearing only a
partial label, the container shall show as a minimum the
name (expressed either as the proper or common name),
the lot number or other lot identification and the name of the manufacturer; in addition, for multiple dose containers, the recommended individual dose. Containers bearing
partial labels shall be placed in a package which bears all
the items required for a package label.
X
d. No container label. If the container is incapable of bearing
any label, the items required for a container label may be
omitted, provided the container is placed in a package
which bears all the items required for a package label.
N/A
e. Visual inspection. When the label has been affixed to the
container a sufficient area of the container shall remain
uncovered for its full length or circumference to permit
inspection of the contents.
X
FDA-CBER-2021-5683-1150295
9 Page 2 – Label Review ( Container ) appendix 2
JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i)
*8. Barcode
Linear or One -Dimensional (1D) (Parallel Lines)
NDC
a. Using the website
https://www.fda.gov/industry/structured -pr oduct -labeling -
resources/ndcnhric -labeler -codes
(to check the sponsor’s NDC)
b. Click “Open”
c. Click “ndc_n hric_labeler_codes”
d. Click “Yes”
e. Locate the Firm Name and the NDC Labeler
Code will be to the right N/A
N/A
*9. Product Identifier - 2D Barcode
a. Locate the symbol and the datamatrix code
information will consist of:
NDC (01):
EXPIRY (17):
BATCH/LOT (10):
SERIAL (21):
N/A
10. Detachable Portion
If the detachable label has a 2D Barcode, then
you need to follow steps #8 & steps #9
(Barcode & NDC/2D Barcode)
The actual detach label needs to include:
a. Proprietary Name
b. NDC #
c. Lot # & Expiry Date
If the detachable label cannot contain all the
above information, then it should have:
a. Proprietary Name
b. NDC #
c. Lot #
N/A
N/A
FDA-CBER-2021-5683-1150296
10 Page 3 – Label Review ( Container ) appendix 2
Selection of the Appropriate Package Type Terms and Recommendations
for Labeling Injectable Medical Products Packaged in Multiple -Dose,
Single -Dose, and Single- Patient -Use Containers for Human Use Guidance
for Industry Checked items “x”
indicate compliance
a. Multiple -Dose
b. Single-Dose
c. Single -Patient -Use
x
11. If there is an age range associated with the label
is should be included on the label. The placement
should not be on the detachable portion.
16 years of age and older
Comments:
2 mL Diluent Sodium Chloride Injection, USP 0.9% Vial Container Label –
Fresenius Kabi .
This label is acceptable for approval .
* Minimum requirement for partial labels
FDA-CBER-2021-5683-1150297
11 Appendix 3: Review Checklist for Multiple -Dose 10 mL (25 Doses) Diluent 0.9% Sodium Chloride
Injection, USP Vial Carton Label: (Package) Label – Hospira (NDC 0409 -4888 -10)
submitted on August 13, 2021; August 17, 2021; and August 19, 2021.
21 CFR 610.61 (a) through (s) Checked items “x”
indicate compliance
a. The proper name of the product; X
b. The name, address, and license number of manufacturer; X
c. The lot number or other lot identification; X
d. The expiration date; X
e. The preservative used and its concentration, or if no preservative
is used and the absence of a preservative is a safety factor, the words
“no preservative”; X
f. The number of containers, if more than one; X
g. The amount of product in the container expressed as
(1) the number of doses, (2) volume, (3) units of potency,
(4) weight, (5) equivalent volume (for dried product to be
reconstituted), or (6) such combination of the foregoing as
needed for an accurate description of the contents, whichever
is applicable; X
h. The recommended storage temperature; X
i. The words “Shake Well”, “Do not Freeze” or the equivalent, as
well as other instructions, when indicated by t he character of
the product; X
j. The recommended individual dose, for multiple dose
containers. 25 Doses
k. The route of administration recommended, or reference to
such directions in an enclosed circular X
l. Known sensitizing substances, or reference to an enclosed
circular containing appropriate information; X
m. The type and calculated amo unt of antibiotics added during
manufacture; X
n. The inactive ingredients when a safety factor, or reference to an
enclosed circular containing appropriate information; X
o. The adjuvant, if present; N/A
p. The source of the product when a factor in safe administration; X
q. The identity of each microorganism used in manufacture, and,
where applicable, the production medium and the method of
inactivation, or reference to an enclosed circular containing
appropriate information X
r. Minimum potency of product expressed in terms of official
standard of potency or, if potency is a factor and no U.S.
standard of potency has been prescribed, the words “No U.S.
standard of potency.” X
s. The statement: “‘Rx only’” for prescription biologicals. X
(b) (4)
FDA-CBER-2021-5683-1150298
12 Page 2 – Label Review (Package) appendix 3
JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21
CFR 207.35 (3)(i) Checked items “x”
indicate compliance
9. Barcode & Linear or One -Dimensional (1D) (Parallel Lines)
NDC
b. Using the website
https://www.fda.gov/industry/structured -pr oduct -labeling -
resources/ndcnhric -labeler -codes
(to check the sponsor’s NDC)
b. Click “Open”
c. Click “ndc_hric_labeler_codes”
d. Click “Yes”
e. Locate the Firm Name and the NDC Labeler
Code will be to the right
X
X
X
X X
X
10. Detachable Portion
If the detachable label has a 2D Barcode, then
you need to follow steps #8 & steps #9
(Barcode & NDC/2D Barcode)
The actual detach label needs to include:
a. Proprietary Name
b. NDC #
c. Lot # & Expiry Date N/A
If the detachable label cannot contain all the above information, then it should
have:
a. Proprietary Name
b. NDC #
c. Lot #
For 2D Barcodes on the carton label to meet the regulations for the Drug
Supply Chain Security Act (DSCSA).
Product Identifier - 2D Barcode
b. Locate the symbol and the datamatrix codes will
consist of:
NDC (01):
EXPIRY (17):
BATCH/LOT (10):
SERIAL (21):
N/A
X
X X
X
X
FDA-CBER-2021-5683-1150299
13 Page 3 – Label Review (Package) appendix 3
Selection of the Appropriate Package Type Terms and Recommendations
for Labeling Injectable Medical Products Packaged in Multiple -Dose,
Single -Dose, and Single- Patient -Use Containers for Human Use Guidance
for In dustry Checked items “x”
indicate compliance
d. Multiple -Dose
e. Single-Dose
f. Single -Patient -Use x
11. If there is an age range associated with the label is should be included
on the label. The placement should not be on the detachable portion.
16 years of age and older
Comments:
Diluent 0.9% Sodium Chloride Injection, USP Vial Carton Label – Fresenius Kabi
This label is acceptable for approval.
FDA-CBER-2021-5683-1150300
14 Appendix 4: Review Checklist for Single -Dose 2 mL Diluent Sodium Chloride Injection, USP
0.9% Vial Container Label – Hospira (NDC 63323- 186-04) submitted on August 17,
2021, and August 19, 2021.
21 CF R 610.60(a)(1) through (7) Checked items “x”
indicate compliance
b. Full label. The following items shall appear on the label affixed to each
container of a product capable of bearing a full label:
X
* 1. The proper name of the product; X
* 2. The name, address, and license number of
manufacturer; X
* 3. The lot number or other lot identification; X
* 4. The expiration date; X
* 5. The recommended individual dose, for multiple dose
containers. 2 mL
* 6. The statement: “‘Rx only’” for prescription biologicals. X
7. If a Medicatio n Guide is required under part 208 of this
chapter, the statement required under §208.24(d) of
this chapter instructing the authorized dispenser to
provide a Medication Guide to each patient to whom
the drug is dispensed and stating how the Medication
Guide is provided, except where the container label is
too small, the required statement may be placed on
the package label.
N/A
21 CFR 610.62 (7) (b) through (e) Checked items “x”
indicate compliance
b. Package label information. If the container is not enclosed
in a package, all the items required for a package label
shall appear on the container label.
N/A
c. Partial label. If the container is capable of bearing only a
partial label, the container shall show as a minimum the
name (expressed either as the proper or common name),
the lot number or other lot identification and the name of the manufacturer; in addition, for multiple dose containers, the recommended individual dose. Containers bearing
partial labels shall be placed in a package which bears all
the items required for a package label.
X
d. No container label. If the container is incapable of bearing
any label, the items required for a container label may be
omitted, provided the container is placed in a package
which bears all the items required for a package label.
N/A
e. Visual inspection. When the label has been affixed to the
container a sufficient area of the container shall remain
uncovered for its full length or circumference to permit
inspection of the contents.
X
(b) (4)
FDA-CBER-2021-5683-1150301
15 Page 2 – Label Review ( Container ) appendix 4
JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i)
*8. Barcode
Linear or One -Dimensional (1D) (Parallel Lines)
NDC
b. Using the website
https://www.fda.gov/industry/structured -pr oduct -labeling -
resources/ndcnhric -labeler -codes
(to check the sponsor’s NDC)
b. Click “Open”
c. Click “ndc_n hric_labeler_codes”
d. Click “Yes”
e. Locate the Firm Name and the NDC Labeler
Code will be to the right N/A
N/A
*9. Product Identifier - 2D Barcode
a. Locate the symbol and the datamatrix code
information will consist of:
NDC (01):
EXPIRY (17):
BATCH/LOT (10):
SERIAL (21):
N/A
10. Detachable Portion
If the detachable label has a 2D Barcode, then
you need to follow steps #8 & steps #9
(Barcode & NDC/2D Barcode)
The actual detach label needs to include:
a. Proprietary Name
b. NDC #
c. Lot # & Expiry Date
If the detachable label cannot contain all the
above information, then it should have:
a. Proprietary Name
b. NDC #
c. Lot #
N/A
N/A
FDA-CBER-2021-5683-1150302
16 Page 3 – Label Review ( Container ) appendix 4
Selection of the Appropriate Package Type Terms and Recommendations
for Labeling Injectable Medical Products Packaged in Multiple -Dose,
Single -Dose, and Single- Patient -Use Containers for Human Use Guidance
for Industry Checked items “x”
indicate compliance
d. Multiple -Dose
e. Single-Dose
f. Single -Patient -Use
x
11. If there is an age range associated with the label
is should be included on the label. The placement
should not be on the detachable portion.
16 years of age and older
Comments:
2 mL Diluent Sodium Chloride Injection, USP 0.9% Vial Container Label –
Fresenius Kabi .
This label is acceptable for approval .
* Minimum requirement for partial labels
FDA-CBER-2021-5683-1150303
17 Appendix 5: Review Checklist for Fresenius Kabi Diluent Stamp No NDC) submitted August 13,
2021; August 17, 2021; and August 19, 2021.
21 CFR 610.60(a)(1) through (7) Checked items “x”
indicate compliance
c. Full label. The following items shall appear on the label affixed to each
container of a product capable of bearing a full label:
X
* 1. The proper name of the product; X
* 2. The name, address, and license number of
manufacturer; X
* 3. The lot number or other lot identification; X
* 4. The expiration date; X
* 5. The recommended individual dose, for multiple dose
containers. Fresenius Kabi Diluent
Stamp
* 6. The statement: “‘Rx only’” for prescription biologicals. X
7. If a Medication Guide is required under part 208 of this
chapter, the statement required under §208.24(d) of
this chapter instructing the authorized dispenser to
provide a Medication Guide to each patient to whom
the drug is dispensed and stating how the Medication
Guide is provided, except where the container label is
too small, the required statement may be placed on
the package label.
N/A
21 CFR 610.62 (7) (b) through (e) Checked items “x”
indicate compliance
b. Package label information. If the container is not enclosed
in a package, all the items required for a package label
shall appear on the container label.
N/A
c. Partial label. If the container is capable of bearing only a
partial label, the container shall show as a minimum the
name (expressed either as the proper or common name), the lot number or other lot identification and the name of the manufacturer; in addition, for multiple dose containers,
the recommended individual dose. Containers bearing
partial labels shall be placed in a package which bears all
the items required for a package label.
X
d. No container label. If the container is incapable of bearing
any label, the items required for a container label may be
omitted, provided the container is placed in a package
which bears all the items required for a package label.
N/A
e. Visual inspection. When the label has been affixed to the
container a sufficient area of the container shall remain
uncovered for its full length or circumference to permit
inspection of the contents.
X
FDA-CBER-2021-5683-1150304
18 Page 2 – Label Review ( Stamp ) appendix 5
JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i)
*8. Barcode
Linear or One -Dimensional (1D) (Parallel Lines)
NDC
c. Using the website
https://www.fda.gov/industry/structured -pr oduct -labeling -
resources/ndcnhric -labeler -codes
(to check the sponsor’s NDC)
b. Click “Open”
c. Click “ndc_n hric_labeler_codes”
d. Click “Yes”
e. Locate the Firm Name and the NDC Labeler
Code will be to the right N/A
N/A
*9. Product Identifier - 2D Barcode
a. Locate the symbol and the datamatrix code
information will consist of:
NDC (01):
EXPIRY (17):
BATCH/LOT (10):
SERIAL (21):
N/A
10. Detachable Portion
If the detachable label has a 2D Barcode, then
you need to follow steps #8 & steps #9
(Barcode & NDC/2D Barcode)
The actual detach label needs to include:
a. Proprietary Name
b. NDC #
c. Lot # & Expiry Date
If the detachable label cannot contain all the
above information, then it should have:
a. Proprietary Name
b. NDC #
c. Lot #
N/A
N/A
FDA-CBER-2021-5683-1150305
19 Page 3 – Label Review ( Stamp ) appendix 5
Selection of the Appropriate Package Type Terms and Recommendations
for Labeling Injectable Medical Products Packaged in Multiple -Dose,
Single -Dose, and Single- Patient -Use Containers for Human Use Guidance
for Industry Checked items “x”
indicate compliance
g. Multiple -Dose
h. Single-Dose
i. Single -Patient -Use
N/A
11. If there is an age range associated with the label
is should be included on the label. The placement
should not be on the detachable portion.
16 years of age and older
Comments:
Fresenius Kabi Diluent Stamp .
This label is acceptable for approval .
* Minimum requirement for partial labels
FDA-CBER-2021-5683-1150306
20 Appendix 6: Review Checklist for Hospira Diluent Sticker Label (No NDC) submitted August 13,
2021; August 17, 2021; and August 19, 2021.
21 CFR 610.60(a)(1) through (7) Checked items “x”
indicate compliance
d. Full label. The following items shall appear on the label affixed to each
container of a product capable of bearing a full label:
X
* 1. The proper name of the product; X
* 2. The name, address, and license number of
manufacturer; X
* 3. The lot number or other lot identification; X
* 4. The expiration date; X
* 5. The recommended individual dose, for multiple dose
containers. Fresenius Kabi Diluent
Stamp
* 6. The statement: “‘Rx only’” for prescription biologicals. X
7. If a Medication Guide is required under part 208 of this
chapter, the statement required under §208.24(d) of
this chapter instructing the authorized dispenser to
provide a Medication Guide to each patient to whom
the drug is dispensed and stating how the Medication
Guide is provided, except where the container label is
too small, the required statement may be placed on
the package label.
N/A
21 CFR 610.62 (7) (b) through (e) Checked items “x”
indicate compliance
b. Package label information. If the container is not enclosed
in a package, all the items required for a package label
shall appear on the container label.
N/A
c. Partial label. If the container is capable of bearing only a
partial label, the container shall show as a minimum the
name (expressed either as the proper or common name), the lot number or other lot identification and the name of the manufacturer; in addition, for multiple dose containers,
the recommended individual dose. Containers bearing
partial labels shall be placed in a package which bears all
the items required for a package label.
X
d. No container label. If the container is incapable of bearing
any label, the items required for a container label may be
omitted, provided the container is placed in a package
which bears all the items required for a package label.
N/A
e. Visual inspection. When the label has been affixed to the
container a sufficient area of the container shall remain
uncovered for its full length or circumference to permit
inspection of the contents.
X
FDA-CBER-2021-5683-1150307
21 Page 2 – Label Review (Sticker) appendix 6
JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i)
*8. Barcode
Linear or One -Dimensional (1D) (Parallel Lines)
NDC
d. Using the website
https://www.fda.gov/industry/structured -pr oduct -labeling -
resources/ndcnhric -labeler -codes
(to check the sponsor’s NDC)
b. Click “Open”
c. Click “ndc_n hric_labeler_codes”
d. Click “Yes”
e. Locate the Firm Name and the NDC Labeler
Code will be to the right N/A
N/A
*9. Product Identifier - 2D Barcode
a. Locate the symbol and the datamatrix code
information will consist of:
NDC (01):
EXPIRY (17):
BATCH/LOT (10):
SERIAL (21):
N/A
10. Detachable Portion
If the detachable label has a 2D Barcode, then
you need to follow steps #8 & steps #9
(Barcode & NDC/2D Barcode)
The actual detach label needs to include:
a. Proprietary Name
b. NDC #
c. Lot # & Expiry Date
If the detachable label cannot contain all the
above information, then it should have:
a. Proprietary Name
b. NDC #
c. Lot #
N/A
N/A
FDA-CBER-2021-5683-1150308
22 Page 3 – Label Review (Sticker) appendix 6
Selection of the Appropriate Package Type Terms and Recommendations
for Labeling Injectable Medical Products Packaged in Multiple -Dose,
Single -Dose, and Single- Patient -Use Containers for Human Use Guidance
for Industry Checked items “x”
indicate compliance
j. Multiple -Dose
k. Single-Dose
l. Single -Patient -Use
N/A
11. If there is an age range associated with the label
is should be included on the label. The placement
should not be on the detachable portion.
16 years of age and older
Comments:
Hospira Diluent Sticker Label .
This label is acceptable for approval .
* Minimum requirement for partial labels
FDA-CBER-2021-5683-1150309
23 Appendix 7: Review Checklist for Multiple -Dose 10 mL (25 Doses) Sterile Diluent Carton Label
(Package) Label: (NDC 0409- 4888 -02) submitted on August 13, 2021; August 17, 2021; and
August 19, 2021.
21 CFR 610.61 (a) through (s) Checked items “x”
indicate compliance
a. The proper name of the product; X
b. The name, address, and license number of manufacturer; X
c. The lot number or other lot identification; X
d. The expiration date; X
e. The preservative used and its concentration, or if no preservative
is used and the absence of a preservative is a safety factor, the words
“no preservative”; X
f. The number of containers, if more than one; X
g. The amount of product in the container expressed as
(1) the number of doses, (2) volume, (3) units of potency,
(4) weight, (5) equivalent volume (for dried product to be
reconstituted), or (6) such combination of the foregoing as
needed for an accurate description of the contents, whichever
is applicable; X
h. The recommended storage temperature; X
i. The words “Shake Well”, “Do not Freeze” or the equivalent, as
well as other instructions, when indicated by the character of
the product; X
j. The recommended individual dose, for multiple dose
containers. Single -Patient = 10 mL
Contains 25
k. The route of administration recommended, or reference to
such directions in an enclosed circular X
l. Known sensitizing substances, or reference to an enclosed
circular containing appropriate information; X
m. The type and calculated amo unt of antibiotics added during
manufacture; X
n. The inactive ingredients when a safety factor, or reference to an
enclosed circular containing appropriate information; X
o. The adjuvant, if present; N/A
p. The source of the product when a factor in safe administration; X
q. The identity of each microorganism used in manufacture, and,
where applicable, the production medium and the method of
inactivation, or reference to an enclosed circular containing
appropriate information X
r. Minimum potency of product expressed in terms of official
standard of potency or, if potency is a factor and no U.S.
standard of potency has been prescribed, the words “No U.S.
standard of potency.” X
s. The statement: “‘Rx only’” for prescription biologicals. X
FDA-CBER-2021-5683-1150310
24 Page 2 – Label Review (Package) appendix 7
JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21
CFR 207.35 (3)(i) Checked items “x”
indicate compliance
9. Barcode & Linear or One -Dimensional (1D) (Parallel Lines)
NDC
c. Using the website
https://www.fda.gov/industry/structured -pr oduct -labeling -
resources/ndcnhric -labeler -codes
(to check the sponsor’s NDC)
b. Click “Open”
c. Click “ndc_hric_labeler_codes”
d. Click “Yes”
e. Locate the Firm Name and the NDC Labeler
Code will be to the right
X
X
X
X X
X
10. Detachable Portion
If the detachable label has a 2D Barcode, then
you need to follow steps #8 & steps #9
(Barcode & NDC/2D Barcode)
The actual detach label needs to include:
a. Proprietary Name
b. NDC #
c. Lot # & Expiry Date N/A
If the detachable label cannot contain all the above information, then it should
have:
a. Proprietary Name
b. NDC #
c. Lot #
For 2D Barcodes on the carton label to meet the regulations for the Drug
Supply Chain Security Act (DSCSA).
Product Identifier - 2D Barcode
c. Locate the symbol and the datamatrix codes will
consist of:
NDC (01):
EXPIRY (17):
BATCH/LOT (10):
SERIAL (21):
N/A
X
X X
X
X
FDA-CBER-2021-5683-1150311
25 Page 3 – Label Review (Package) appendix 7
Selection of the Appropriate Package Type Terms and Recommendations
for Labeling Injectable Medical Products Packaged in Multiple -Dose,
Single -Dose, and Single- Patient -Use Containers for Human Use Guidance
for In dustry Checked items “x”
indicate compliance
g. Multiple -Dose
h. Single-Dose
i. Single -Patient -Use
x
11. If there is an age range associated with the label is should be included
on the label. The placement should not be on the detachable portion.
16 years of age and older
Comments:
0.9 Sodium Chloride Injection, USP Contains 25 (KZOO & PUURS)
This label is acceptable for approval.
FDA-CBER-2021-5683-1150312
26 Appendix 8: Review Checklist for Multiple -Dose (195 Doses) Vial Carton Label:
(Package) Label (NDC 0069- 1000 -02) submitted on August 13, 2021; August 17, 2021; and
August 19, 2021.
21 CFR 610.61 (a) through (s) Checked items “x”
indicate compliance
a. The proper name of the product; X
b. The name, address, and license number of manufacturer; X
c. The lot number or other lot identification; X
d. The expiration date; X
e. The preservative used and its concentration, or if no preservative
is used and the absence of a preservative is a safety factor, the words
“no preservative”; X
f. The number of containers, if more than one; X
g. The amount of product in the container expressed as
(1) the number of doses, (2) volume, (3) units of potency,
(4) weight, (5) equivalent volume (for dried product to be
reconstituted), or (6) such combination of the foregoing as
needed for an accurate description of the contents, whichever
is applicable; X
h. The recommended storage temperature; X
i. The words “Shake Well”, “Do not Freeze” or the equivalent, as
well as other instructions, when indicated by the character of
the product; X
j. The recommended individual dose, for multiple dose
containers. Single -Patient = 10 mL
Contains 25
k. The route of administration recommended, or reference to
such directions in an enclosed circular X
l. Known sensitizing substances, or reference to an enclosed
circular containing appropriate information; X
m. The type and calculated amo unt of antibiotics added during
manufacture; X
n. The inactive ingredients when a safety factor, or reference to an
enclosed circular containing appropriate information; X
o. The adjuvant, if present; N/A
p. The source of the product when a factor in safe administration; X
q. The identity of each microorganism used in manufacture, and,
where applicable, the production medium and the method of
inactivation, or reference to an enclosed circular containing
appropriate information X
r. Minimum potency of product expressed in terms of official
standard of potency or, if potency is a factor and no U.S.
standard of potency has been prescribed, the words “No U.S.
standard of potency.” X
s. The statement: “‘Rx only’” for prescription biologicals. X
FDA-CBER-2021-5683-1150313
27 Page 2 – Label Review (Package) appendix 8
JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21
CFR 207.35 (3)(i) Checked items “x”
indicate compliance
9. Barcode & Linear or One -Dimensional (1D) (Parallel Lines)
NDC
d. Using the website
https://www.fda.gov/industry/structured -pr oduct -labeling -
resources/ndcnhric -labeler -codes
(to check the sponsor’s NDC)
b. Click “Open”
c. Click “ndc_hric_labeler_codes”
d. Click “Yes”
e. Locate the Firm Name and the NDC Labeler
Code will be to the right
X
X
X
X X
X
10. Detachable Portion
If the detachable label has a 2D Barcode, then
you need to follow steps #8 & steps #9
(Barcode & NDC/2D Barcode)
The actual detach label needs to include:
a. Proprietary Name
b. NDC #
c. Lot # & Expiry Date N/A
If the detachable label cannot contain all the above information, then it should
have:
a. Proprietary Name
b. NDC #
c. Lot #
For 2D Barcodes on the carton label to meet the regulations for the Drug
Supply Chain Security Act (DSCSA).
Product Identifier - 2D Barcode
d. Locate the symbol and the datamatrix codes will
consist of:
NDC (01):
EXPIRY (17):
BATCH/LOT (10):
SERIAL (21):
N/A
X
X X
X
X
FDA-CBER-2021-5683-1150314
28 Page 3 – Label Review (Package) appendix 8
Selection of the Appropriate Package Type Terms and Recommendations
for Labeling Injectable Medical Products Packaged in Multiple -Dose,
Single -Dose, and Single- Patient -Use Containers for Human Use Guidance
for In dustry Checked items “x”
indicate compliance
j. Multiple -Dose
k. Single-Dose
l. Single -Patient -Use x
11. If there is an age range associated with the label is should be included
on the label. The placement should not be on the detachable portion.
16 years of age and older
Comments:
Multiple-Dose (195 Doses) Vial Carton (KZOO & PUURS).
This label is acceptable for approval.
FDA-CBER-2021-5683-1150315
29 Appendix 9: Review Checklist for Single- Dose 0.25 mL Syringe Container Label (NDC 0069 -
1000 -01) submitted August 13, 2021; August 17, 2021 ; and August 19, 2021.
21 CFR 610.60(a)(1) through (7) Checked items “x”
indicate compliance
e. Full label. The following items shall appear on the label affixed to each
container of a product capable of bearing a full label:
X
* 1. The proper name of the product; X
* 2. The name, address, and license number of
manufacturer; X
* 3. The lot number or other lot identification; X
* 4. The expiration date; X
* 5. The recommended individual dose, for multiple dose
containers. Single Dose = .25 mL
* 6. The statement: “‘Rx only’” for prescription biologicals. X
7. If a Medication Guide is required under part 208 of this
chapter, the statement required under §208.24(d) of
this chapter instructing the authorized dispenser to
provide a Medication Guide to each patient to whom
the drug is dispensed and stating how the Medication
Guide is provided, except where the container label is
too small, the required statement may be placed on
the package label.
N/A
21 CFR 610.62 (7) (b) through (e) Checked items “x”
indicate compliance
b. Package label information. If the container is not enclosed
in a package, all the items required for a package label
shall appear on the container label.
N/A
c. Partial label. If the container is capable of bearing only a
partial label, the container shall show as a minimum the
name (expressed either as the proper or common name), the lot number or other lot identification and the name of the manufacturer; in addition, for multiple dose containers,
the recommended individual dose. Containers bearing
partial labels shall be placed in a package which bears all
the items required for a package label.
X
d. No container label. If the container is incapable of bearing
any label, the items required for a container label may be
omitted, provided the container is placed in a package
which bears all the items required for a package label.
N/A
e. Visual inspection. When the label has been affixed to the
container a sufficient area of the container shall remain
uncovered for its full length or circumference to permit
inspection of the contents.
X
FDA-CBER-2021-5683-1150316
30 Page 2 – Label Review (Container) appendix 9
JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i)
*8. Barcode
Linear or One -Dimensional (1D) (Parallel Lines)
NDC
e. Using the website
https://www.fda.gov/industry/structured -pr oduct -labeling -
resources/ndcnhric -labeler -codes
(to check the sponsor’s NDC)
b. Click “Open”
c. Click “ndc_n hric_labeler_codes”
d. Click “Yes”
e. Locate the Firm Name and the NDC Labeler
Code will be to the right N/A
N/A
*9. Product Identifier - 2D Barcode
a. Locate the symbol and the datamatrix code
information will consist of:
NDC (01):
EXPIRY (17):
BATCH/LOT (10):
SERIAL (21):
N/A
10. Detachable Portion
If the detachable label has a 2D Barcode, then
you need to follow steps #8 & steps #9
(Barcode & NDC/2D Barcode)
The actual detach label needs to include:
a. Proprietary Name
b. NDC #
c. Lot # & Expiry Date
If the detachable label cannot contain all the
above information, then it should have:
a. Proprietary Name
b. NDC #
c. Lot #
N/A
N/A
FDA-CBER-2021-5683-1150317
31 Page 3 – Label Review (Container) appendix 9
Selection of the Appropriate Package Type Terms and Recommendations
for Labeling Injectable Medical Products Packaged in Multiple -Dose,
Single -Dose, and Single- Patient -Use Containers for Human Use Guidance
for Industry Checked items “x”
indicate compliance
m. Multiple -Dose
n. Single-Dose
o. Single -Patient -Use
x
11. If there is an age range associated with the label
is should be included on the label. The placement
should not be on the detachable portion.
16 years of age and older
Comments:
Single-Dose 0.25 mL Syringe Container Label (KZOO & PUURS)
This label is acceptable for approval .
* Minimum requirement for partial labels
FDA-CBER-2021-5683-1150318