Labelling of Drugs for Human Use

1
Labelling of Drugs for Human Use

• Term labelling is all-inclusive
• Includes extensions of the labels
• Therefore when a submission or request for
  labelling material is made, all affected
  documents must be submitted

2
Guideline

• Drugs Directorate Guideline Labelling of Drugs
  for Human Use 1989

3
General Requirements

• guideline addresses requirements of the Food
  Drugs Act and includes
• exemptions for the prohibition of Schedule A
  diseases
• definition of prescribed standard (Div. 6)

4
. . . .General Requirements

• guideline addresses requirements of the Food
  Drug Regulations and includes supplemented
  sections relating to Over-the Counter (OTC)
  Medicines and Prescribed and Parenteral Drugs

5
. . . . . .General Requirements

• where a package of a drug has only one label,
  that label must carry all the information
  required by Section C.01.006 of the Regulations

6
Type Size

• no specific type size is mentioned in the
  Regulations
• however, a person with 20/20 uncorrected vision
  should be able to read the information without
  straining
• colour contrast, position and spacing must be
  taken into consideration

7
Abbreviations

• proper and common names of product and API are to
  be written in full
• abbreviations for units of weight, volume or
  potency are accepted as the National Standard for
  Canada by the Metric Commission

8
Mandatory Information

• all mandatory information must be placed on the
  main panel
• proper or common name
• DIN
• standard
• other information may be required by specific
  regulations

9
Declaration of Medicinal Ingredients

• quantities of all medicinal ingredients must be
  declared on the inner and outer label
• for single ingredient preparations, the medicinal
  ingredient declaration should follow or precede
  the proper or common name

10
Name Address of Manufacturer

• manufacturer of record (MoR) (DIN holder) is
  identified on the label
• MoR is not necessarily the fabricator
• when MoR is not Canadian, the name address of
  the Canadian importer must appear
• all foreign addresses must include country name

11
Lot Number

• required on both inner and outer labels in one of
  the following designations
• Lot Number
• Lot No.
• (L)

12
Net Contents

• outer label only
• net contents must be expressed in metric units

13
Adequate Directions for Use

• Adequate directions for use means all
  information, including such cautions and warnings
  as may be necessary for the proper and
  recommended use of the drug

14
Adequate Directions for Use

• indications for use
• an indication of the route of administration
• the recommended single and daily dose

15
Warnings Cautions

• there are several cautionary statements required
  by the Regulations (e.g. phenacetin, salicylic
  acid)
• cautions shown within quotation marks in the
  Regulations with must be printed verbatim
• no quotation marks, the wording may be altered

16
Expiration Dates

• present drug regulations do not require that the
  declaration of expiration dates on drug labels be
  preceded by a specific explanatory statement
• however, the expression must be such that a
  member of the general public will recognize the
  meaning of the date

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. . . . . .Expiration Dates

• the following two letter abbreviations for months
  are considered acceptable in both official
  languages
• JA. FE, MR, AL, MA, JN, JL, AU, SE, OC, NO, DE

18
Labelling of Drugs in Small Containers

• labelling requirements apply to all container
  sizes
• Regulations allow for exemptions for small
  container, primarily parenterals

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OTC Medications

• guideline addresses two types of OTC drugs
• self select products
• medicines that do not require a prescription but
  require advice from a health care professional
  for proper use
• general labelling requirements apply

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. . . . . . . .OTC Medications

• special attention should be given to
• directions for use
• indications
• recommended dose
• route of administration
• warnings and cautions
• declaration of ingredients

21
Prescribed and Parenteral Drugs

• general labelling requirements apply
• language used in the labelling is oriented
  towards health care professionals
• symbol for drugs listed in Schedule F, must
  appear in the upper corner of the main panel of
  the label

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. . . Prescribed and Parenteral Drugs

• symbol for Schedule G drugs must appear in the
  upper corner of the main panel of the label
• requirements of the Narcotic Control Act must be
  met

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. . . Prescribed and Parenteral Drugs

• for parenteral product, general labelling
  requirements apply
• specific requirements for
• common name
• declaration of ingredients
• preservatives

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Rx Outer Labelling Template
DRAFT LABELLING FOR PrBrand name (common
name) Dosage Form COMPONENT Outer Label
SIDE PANEL (FRENCH) MAIN PANEL (ENGLISH) SIDE PANEL (ENGLISH) MAIN PANEL (FRENCH)
Add directions for use....... Lire le feuillet ci-joint. Monographie du produit fournie sur demande aux médecins at aux pharmaciens. Storage conditions(add degree symbol) Trademark statement DIN DIN Net contents of pack Pr Brand name common name Dosage Form strength box common name/unit Therapeutic classification (CAPS) Route of admin (if not oral) Add directions for use..... See package insert. Product Mongraph available to physicians and pharmacists on request. Storage conditions(add degree symbol) Trademark statement DIN DIN Net contents of pack Pr Brand name common name Dosage Form strength box common name/unit Therapeutic classification (CAPS) Route of admin(if not oral)
SENECA PHARMA 4700 Keele St. Toronto, ON M0M 2GO SENECA PHARMA SENECA PHARMA 4700 Keele St. Toronto, ON M0M 2GO SENECA PHARMA
TOP FLAP BOTTOM FLAP
Net contents of pack Pr Brand name strength box Lot EXP UPC/Pharmacode
g or mg per dosage form g or mg per g, and per
specific dosage unit (e.g. level teaspoon) mg per
mL, or where such practice has been
established g or mg per dosage unit, or per mL mg
or mL per g or mL, or (Specify as w/w,w/v or
v/v) Use compendial standard, eg. USP, or
manufacturers standard if the product differs in
some respect from the pharmacopeial standard.
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Rx Inner Labelling Template
DRAFT LABELLING FOR PrBrand name common
name dosage form COMPONENT Inner Label
Lot EXP MAIN PANEL (BILINGUAL) DIN DIN Pr Brand name common name dosage form strength boxcommon name / unit Therapeutic classification (CAPS) Route of admin (if not oral) SENECA PHARMA SIDE PANEL (ENGLISH)
Lot EXP MAIN PANEL (BILINGUAL) DIN DIN Pr Brand name common name dosage form strength boxcommon name / unit Therapeutic classification (CAPS) Route of admin (if not oral) SENECA PHARMA Add directions for use...... See package insert. Product Monograph available to physicians and pharmacists on request. Storage conditions (add degree symbol) Trademark statement (from PM) SENECA PHARMA Inc. Toronto, Ontario
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Labelling

• REMEMBER
• Declaration of Medicinal Ingredients
  C.01.004(1)(c) iv
• Declaration of Standard C.01.004(1)

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Questions

• PRA700