This document discusses guidelines for repackaging and relabeling pharmaceutical products. It states that repackaging should only be done by properly authorized entities in accordance with good manufacturing practices and applicable regulations. When repackaging occurs, efforts must be made to ensure the quality of the product and that the new packaging provides equivalent or better identification and authentication of the product compared to the original manufacturer's packaging. The document also outlines specific criteria for assigning a new expiration or "beyond use" date when a product is repackaged, including limiting the date to no more than 6 months after repackaging or 25% of the remaining time to the original expiration date.

1. BY
AJAY LOHAN
M.PHARMA.

2. Repacking and relabelling are used to
describe operation in a drug product
obtained from the manufacture is
packaged and labelled for distribuition to a
wholesalers or to retail outlet.
 the repacking and relabelling are little
differ from the operation of manufacturer
who has drug product in bulk storage and
package ,label it in the final market
container.

3. The major difference is that the
manufacturer has more about the quality
and storage condition of the drug product
than the repacker.
It is important that the repacker make
special effort to be assured of the quality of
product being repacked.

4.  Repackaging and relabelling of
pharmaceutical products should be limited,
as these practices may represent a risk to
the safety and security of the supply chain.

5.  Where they do occur, they should only be
performed by entities appropriately
authorized to do so and in compliance with
the applicable national, regional and
international guidelines, i.e. in accordance
with GMP principles

6.  In the event of repackaging by companies
other than the original manufacturer, these
operations should result in at least
equivalent means of identification and
authentication of the products

7. • Is the product what it purports to be
Identity
• What happen to the product during
transportation and bulk storage or
both at manufacturer and
repackager point
strength
• What is the proper method of setting
the expiry date when it is
repackaged in a different container
Expiration date
The 3 major area of concern are-

8. Code of Federal Regulations (CFR)
It is codification of the general and
permanent rules and regulations
Published by the executive departments and
agencies of the Fedral Government Of
United State

9. • Updated on 1 january
Title 1-16
• Updated on 1 aprilTitle 17-27
• Updated on 1 julyTitle 28-41
• Updated on 1
october
Title 42-50
The CFR is divided into 50 titles that
represent broad areas subject to Federal
regulation.

10. The rules and regulations are first
promulgated or published in the Federal
Register.

11. NARA also keeps an online version of the
CFR, the e-CFR, that is normally updated
two days after changes to the regulations,
that have been published in the Federal
Register, become effective.

12. title 42
part 260
Section 11
Paragraph (a)(1)
Example of a CFR code indicate-

13. As saving tool
As a means for more extensive information,transmisssion and delivery
As systematic and selective sorter of useful information
As translation tool
As a means of prompt delivery of relevant information

14. When drug is
repackaged
Product’s expiration date is
altered or interrupted

15. A beyond-use date (BUD) is the date
beyond which medications that have been
manipulated and/or repackaged and stored
or dispensed in a container other than the
original manufacturer’s storage container
should not be used

16.  BUD for the fact that the manufacturer's original
container has been opened in the aseptic
manipulation process.
The containers into which dosage forms are
repackaged may not have the integrity of the
original package, necessitates a shortening of the
expiration period from that originally set by the
manufacturer.
The appropriate terminology to be used on the
“repackaged” drug prescription labels is "Beyond-
Use Date."

17. The expiration date and beyond use date
(BUD) are two very different things.
USP defines the expiration date as "the
time during which the article may be
expected to meet the requirements of the
pharmacopeial monograph provided it is
kept under the prescribed conditions."

18. An expiration date is the date beyond
which ideally stored medications in the
unopened manufacturer’s storage
container – or in most circumstances – the
opened, intact manufacturer’s storage
container should not be used.

19. 1. The repackager may perform stability
studies on the repackaged product to
establish an expiration date for the drug
product in container closure system in
which it is marketed.

20. For unit dose packaging,criteria is as follow-
1.the original bulk container should not
be opened previously.

21. 2.The content of the bulk product to be
packaged are repackaged at one time
3.The unit dose container meets USP
general testing requirement for either class
A or class B containers

22. Does not exceed 6 month from date of
repackaging
Does not exceed the manufacturer’s
expiration date
Does not exceed 25% of the time between
the date of repackaging and expiration date
B
U
D
4

23. Does not exceed 6 month from date of
repackaging
Does not exceed the manufacturer’s
expiration date
Does not exceed 25% of the time between
the date of repackaging and expiration date
B
U
D
4 EXPIRATION DATE OR BUD

24. It should be done to ensure that
preceding criteria are met.
To show that the type of packaging
material used and testing of these
material also kept in file.
5.Documentation

25. Repackager may not repackage
But if it is accordance to FDA & in aggrement with
manufacturer,can afffix the repackager labelling
if the manufacturer specifically states that
“DO NOT REPACKAGE”

26. The repackager may not
use the expiration date and
BUD interchangeably
because
They imply the
presence or
absence of stability
testing respectively
7

27. The General Notices define multiple-
unit packaging as a package that
contains more than one single-dosage
unit

28. For multiple-unit packaging, the
following criteria should be considered
In assigning a BUD
1. The original bulk container of drug
product to be used for repackaging has
not been previously opened

29. 2. The contents of the original bulk
drug product to be packaged are
repackaged at one time.
3. The conditions of storage meet the
storage specifications in the General
Notices and as described in the labeling
of the manufacturer's bulk product
.

30. Where no specific storage conditions
are specified
the product should be maintained at
controlled room temperature and in a
dry place during repackaging

31. 4.The type of container used for
repackaging should be the same type as
used by the manufacturer and the
product container should be composed
of an approved food contact substance

32.  other than glass or high
density polyethylene
(HDPE),
 may use a container that
has to be equivalent to, or
exceed the properties of
manufacturer’s container
polyethylene, the repackager
may repackage in a chemical-
resistant glass container or
a polyethylene container

33. The containers used by the repackager
should meet the appropriate tests and
specifications in 21 CFR and USP
general test
6.The container meets or exceeds in
the test results of the manufacturer's
multiple-unit container for light
transmission

34. 7.The container meets or exceeds the
manufacturer's container in special
protective features like
In prevention of leaching of container
material
In maintainance of low moisture content
by use of desiccants

35. Repackager may not repackage
But if it is accordance to FDA & in aggrement with
manufacturer,can afffix the repackager labelling
if the manufacturer specifically states that
“DO NOT REPACKAGE”

36. The repackager is expected to
to perform appropriate analytical testing for all
pertinent specifications and any other finished
product tests to establish valid analytical data.
maintain records of such analyses on a batch-by-
batch that is either transferred to the repackager by
the manufacturer or independently maintained by the
repackager

37.  1.The bulk article should be distributed to the
repackager in accordance with all regulatory
requirements and accompanied by appropriate
labeling and a valid expiration date.
 The repackager should also receive Material Safety
Data Sheets (MSDS), Certificates of Analysis and
sample market labeling, including inserts from the
drug product manufacturer.

38. 2.The bulk article should be received
intact and undamaged and in properly
labeled containers with the Certificate
of Analysis.

39. 3.The bulk article should undergo
definitive organoleptic evaluations to
confirm its identity
(e.g., physical appearance, marking,
color, and odor) and to confirm the
labeling as described by the
manufacturer

40.  4.Records should be maintained to verify
the identity and quantity of each shipment
received and to verify the lot number and
bar coded information for each article of
the bulk shipment received.
 This record should also include the name
of the manufacturer or supplier and its lot
numbers and the date of receipt

41. 5.The repackager should store and
maintain the bulk under storage
conditions specified by the
manufacturer, and/or as directed under
Controlled Room Temperature

42.  The following criteria should be observed.
 1.The repackaging operations should be
conducted under conditions that meet
specified storage temperature definitions .
 Conditions of operation include
maintenance of controlled room
temperature or other as instructed by the
manufacturer

43. 2.The manufacturer should include
appropriate literature for the
repackager information about the
packaging materials as well as oxygen
transmission and light transmission
characteristics

44. 3.The repackaging containers are
labeled with the same labeling
information as that is used by the
manufacturer.
The conditions on the labeling comes
under 21 CFR 201, 211.122, 211.125,
and 211.130

45. 4.Written procedures should be
maintained to ensure that correct
labels, labeling and packaging materials
are used for drug products
5.All requirements for repackaging of
bulk products should meet 21 CFR 211

46. 1. A repackager may not repackage
A moisture- and temperature-sensitive
product if the manufacturer so instructs
except if the repackager is only altering the
labeling in accordance with FDA
requirements.

47. 2.The repackaging container should
show the equivalent of, or be better in
protective properties than, the
manufacturer's original container.
 For moisture-sensitive products, a
higher-barrier container should be used
for repackaging

48. 3.The repackager should have proper
documentation in place to show the
equivalency in protection of the container
used.
4.The storage and handling of the drug
product should meet the conditions
specifically instructed by the manufacturer
of the product.
5.The repackager should label the container
“Contains moisture-sensitive product.”

49. (A) Labels of drugs repackaged by and
stored within a pharmacy prior to being
dispensed shall contain, but not be
limited to, the following-

51. 1.Name of drug, strength and dosage
form
2. The identification of the repackager by
name or by the final seven digits of
their distributer drugs license number
3. Pharmacy control number

52. 4.Expiration date or beyond-use date

54. A record of all drugs repackaged and
stored shall be kept for at least three
years or one year past manufacturer’s
expiration date, whichever is greater.

55. 1.Name of drug, strength, dosage form, and
quantity
2. Manufacturer’s or distributor’s control number
3. Manufacturer’s or distributor’s name, if a
generic drug is used
4 .Pharmacy control number
5 .Manufacturer’s or distributor’s expiration date
6.identification of the pharmacist responsible for
the repackaging of the drug

56. Created by a pharmacy that contain a
barcode for the purpose of identifying a
drug shall contain a means of
identifying the positive identification of
the pharmacist responsible for-
1.The creation of the barcode; and
2. Affixing the barcode label to the drug
product

57. In addition to the general requirements
all unit dose repackaged products are to
be placed into large containers and
each container must be fully labelled
prior to removal from the premises.
- ATTACHMENT A
-ATTACHMENT B

58.  PRESCRIPTION DRUGS
 The established name of the drug and quantity
of the active ingredients per dosage unit, if a
single active ingredient product.
 If a combination of the drug, the established
name and quantity of each active ingredient per
dosage unit label must bear the established
name and quantity or proportion of any
ingredient, named in sections 50, part ‘C’
whether active or not.

59. FOR SOLID DOSAGE FORM-
Declaration of potency per tablet or
capsule.
FOR LIQUID DOSAGE FORM-
Declaration of total volume and
proportion of the active ingredients.

60.  The expiration date
 The lot or control number.
 The name and place of business of the
manufacturer, packer or distributor.
 For a drug recognized in an official
compodium the subject of an approve new
drug application(NDA) or as provided by
the regulation

61. (A)Required statement such as “PREOTECT FROM
LIGHT”, “DILUTE BEFORE USING”
(B)Any pertinent statement bearing on the subject
special characters of the dosage form.
 e.g Sustained release.
 Enteric coated.
 Chewable.
(C) Any information needed to alert the health
professional that a procedure is necessary, prior
to patient administration to prepare the product
as a finished dosage form.
 e.g Shake well before use.

62. Warning “May be habit forming” where
applicable.
National Drug code designation

63. Relabelling requirements for over the
counter drugs are same as for the
PRESCRIPTION DRUGS
In addition-
The expiration date dose not exceed
six months

64. the bulk containers has not been
opened previously.
This policy does not apply to antibiotics
and nitroglycerine sublingual tablets,
which are known to have stability
problem that preclude them from being
repackaged.

65. B) Quantity of dose, including usual
qualities for each of the uses for which
it is intended and usual quantities for
person of different ages and conditions.
(C) Frequency of administration.
(D) Duration of administration.
E) Time of administration (in relation
to time of meal time of onset of
symptoms or other time factors).

66.  No action will be initiated against any unit
dose repackaging firm, meeting all
conditions of FDA’S repackaging
requirements, solely on the basis of the
failure of the repackaging firm to have the
stability study supporting the expiration
dates used provided.
 (A) The unit dose container complies with
the class A or class B standard described
in the twentieth edition of the UNITED
STATE PHARMACOPEIC general tests.

68.  Sidney H.Willig;”Good Manufacturing Practices for
Pharmaceuticals” fifth edition ,revised and expanded,
published by CBS Publisher and Distributors
 http://apps.who.int/medicinedocs/en/d/Js4899e/16.11.ht
ml
 http://codes.ohio.gov/oac/4729-9-20


69. THANK
YOU