PHARMDOS LAB: PHARMACUTICAL MOD SEM

DOSAGE FORMS, DRUG DELIVERY 2 1

MODULE 2.2: LABELING AND PACKAGING

PHARMACEUTICAL PACKAGING TAPE • paper or foil sealed

• used to store and protect drugs SEAL over carton flap or
• should be stored in proper container battle cap
• maximum quality should be given to consumers • must be torn or broken
essential for: to reach the product
→ identification purposes BREAKABLE CAP • plastic or metal tear
→ marketing and promoting different brands
away cap
• must be broken to
→ facilitating the use of pharmaceutical products
remove
PRIMARY PACAKGING • is in direct contact with the SEALED • seal over mouth of
product TUBE tube
SECONDARY PACKAGING • is not in direct contact with • must be punctured to
the product (box) reach product
• e.g. product inserts, tags.
TERTIARY PACKAGING • bulk/storage for
transportation SEALED CARTON • carton flaps sealed
• carton cannot be
TAMPER EVIDENT PACKAGE opened without
• defined as “one having one or more indicators or damage
barriers to entry which, if breached or missing, can AEROSOL CONTAINER • tamper resistant by
reasonably be expected to provide visible evidence to design
consumers that tampering has occurred
• indicators or barriers may involve the immediate drug
product container and/or an outer container or carton

EXAMPLES OF TAMPER-EVIDENT PACKAGING CHILD RESISTANT PACKAGING

FILM WRAPPER • sealed around product • significantly difficult for children under 5 years of age to
or product container open or to obtain a harmful amount of its contents
within a reasonable time and that it is not difficult for
• film must be cut or
torn to remove normal adults to use properly
product
CONTAINERS
BLISTER/STRIP PACK • individually sealed
dose units • is that which holds the article and
• removal require is or may be in direct contact with
tearing or breaking the article
individual • standards for packaging of
compartment pharmaceutical by manufacturers
BUBBLE PACK • product and container are contained in the CGMP section of the code of
sealed in plastic, Federal Regulations, in the USP NF, and in the FDA’s
usually mounted on Guideline in submitting Documentation for Packaging for
display card Human Drugs and Biologics
• plastic must be cut or
broken open to IMMEDIATE CONTAINER
remove product
• direct contact with the article (product) at all times
SHRINK SEAL BAND • band or wrapper
shrunk by heat or THINGS TO CONSIDER IN CHOOSING A CONTAINER
drying to conform cap
→ physicochemical properties
• must be torn to open → light transmission for glass/plastic
package
→ drug compatibility
BOTTLE • paper or foil sealed to → leaching and/or migration
SEAL the mouth of container → vapor transmission for plastics
under the cap
→ moisture barrier
• must be torn or broken → valve, actuator, meter dose, particle size, spray
to reach the product
characteristics, and leaks for aerosols
→ sterility and permeation for parenteral containers
→ drug stability for all packaging

GIANNA ALEXIS LINGAD 1

 TYPES OF CONTAINERS
WELL CLOSED CONTAINER • minimally acceptable
container, protects
contents from
extraneous solids and
from loss of the article
under ordinary
conditions of handling,
shipment, storage, and
distribution
TIGHT CONTAINER • protects the contents
from contamination by
extraneous liquid,
solids, or vapors, from
loss of the article, and
from efflorescence,
deliquescence,
evaporation under the
ordinary or customary
conditions of handling,
shipment, storage, and
distribution
HERMETIC CONTAINER • impervious to air or any
other gas under the
ordinary or customary
conditions of handling,
shipment, storage, and
distribution
STERILE HEMETIC CONTAINER • holds preparations
intended for injection
or parenteral
administration
SINGLE DOSE SINGLE DOSE
MULTIPLE DOSE CONTAINER • holds a quantity of drug
intended as a single
dose and when opened,
cannot be resealed with
assurance that sterility
has been maintained
• e.g ampules, nebules
MULTIPLE DOSE
• permits withdrawal of
successive portions of
the contents without
changing the strength
or endangering the
quality or purity of
remaining portion
• e.g. vials
SINGLE UNIT/MULTIPLE UNIT SINGLE UNIT
CONTAINER • designed to hold a
quantity of drug
intended for
administration as a
single dose promptly
after the container is
opened
MULTIPLE UNIT
• contain more than a product name: generic and
single unit or dose of brand name
the medication for
dosage form and strength
tablets, capsules, or oral
pharmacologic category
liquid
formulation/composition
LIGHT RESISTANT CONTAINER • intended to provide
protection from light,
must meet USP
standards that define
the acceptable limits of
light transmission at any
wavelength between
290- 450 nm
• e.g high density
polyethylene bottle,
amber bottle
PHARMACEUTICAL LABELS
ADMINISTRATIVE ORDER 2016-0008
• revised rules and regulations governing the generic
labeling requirements of drug products for human use
ARTICLE 3, SECTION 7
• declares that the state recognizes the right of the
people to gain information on matters of public
concern, such as those relating to health and health
products
• labels and labeling materials are the primary sources of
information for consumers
a. formulation/composition
b. dosage and mode of administration
c. contraindications
d. generic name
e. brand name
f. dosage form and strength
g. indications
h. name and address of manufacturer
i. net content of pack size
j. batch number & lot number, expiration date and date of
manufacture
k. warnings
l. overdosage and treatment
m. storage condition
n. warnings
REVISED RULES & REGULATIONS GENERIC LABELING
REQUIREMENTS OF DRUG PRODUCTS FOR HUMAN USE
GENERAL GUIDELINES
SECTION V
MINIMUM MANDATORY INFORMATION
storage condition(s)
net content or pack size
name and address of manuf
name and address of
manufacturer
 indication(s)
dosage and mode of
administration
contraindication(s),
precaution (s), warning(s)
interactions
adverse drug reaction(s)
overdosage and treatment
Rx symbol and caution
statement – Rx drugs
ADR reporting statement
registration number
PRODUCT WITH MULTIPLE APIs
batch number and lot number
(if any) • all of the APIs shall be indicated and enumerated in
expiration date and date of order of decreasing pharmacologic activity
manufact placed in the box in either of the given format:

GENERAL GUIDELINES
INFORMATION ON THE LABEL
• written in english or filipino
• clearly and prominently displayed
• readable with normal vision without straining
• color contrast
APIS WITH MORE OR LESS SIMILAR PHARMACOLOGIC ACTIVITY
• position
• shall be enumerated in the order of decreasing potency
• spacing of the info and strength

PACKAGE INSERT (P)

• single approved name for fixed-dose combination shall
be used
• NCEs, biological products, Rx generic products and
herbal medicines
• generic class name shall be used

• SPC - basis for PI for NCEs and biological products

• individual components of the single approved name
shall be enumerated under formulation
PACKAGE INFORMATION LEAFLET (PIL)
B. DOSAGE FORM AND STRENGTH
• household remedies
• the label shall specify
• OTC drug and herbal medicines
• dosage form (tablet, capsule, suspension, ointment, etc.)
• traditionally used herbal products
• specific delivery system (modified release)
PRODUCTS TO BE DISPENSED WITH UNIT CARTON • specific mode of administration – if any
(vaginal/rectal suppository)
• in lieu of PI/PIL the foregoing information shall be
printed directly on the reverse side or inner panel of the • if no qualifier for tablets, it is understood as an oral,
outer packaging material or inner carton uncoated, IR table
Dosage Strength
PRODUCTS WITHOUT ANY PRODUCT INFORMATION SHEET AND → expressed in metric units
UNIT CARTON → reduced in lowest terms
• minimum mandatory information shall be reflected on → in number of the largest unit specified (500 mcg, not 0.5
the primary label mg)

• Primary Label – label on the primary packaging material • strength of semisolid, ophthalmic, otic, nasal and topic
• preparations – expressed as percentage (%)
SPECIFIC GUIDELINES
SECTION VI PRODUCT WITH MULTIPLE APIS
A. PRODUCT NAME Dosage Strength
• shall indicate the generic name (INN) & brand name (if → indicated in accordance with the generic name
any) → separated by a slash sign (/)
→ prodrugs generic name
• if single approved name is used, the dosage strength
• generic name shall appear prominently with an outline shall be indicated as the sum
box
• if with brand name, generic name enclosed in an outline
box shall appear immediately above the brand name
• narrative texts (unit carton, primary label, insert, brand
name shall be preceded by the generic name and
enclosed in parentheses/brackets)
Herbal Medicines
• generic name shall be the botanical origin or as
recognized by FDA
 C. PHARMACOLOGIC CATEGORY
• shall be as determined by FDA, taking into consideration
current acceptable standards for therapeutic categories
D. FORMULATION/COMPOSITION
label shall state:
• name and strength of all APIs present per unit dose
arrange in decreasing pharmacologic activity
• with more or less pharmacological activity
→ decreasing potency and strength
• generic name shall be stated in full (including salts and
esters, if any)
• herbal medicines and traditionally used herbal products
→ based on official Phil. Pharmacopoeia or as
determined by FDA
• the reference monograph recognized by FDA (USP, BP,
etc.) shall be indicated immediately after the API
• separate directions for use by special populations,
adults, and children shall be stated
• if the product is not recommended for children, the
dosage shall be clearly identified as “adult dose” or any
statement to that effect
G. CONTRAINDICATIONS, PRECAUTIONS, WARNINGS
shall contain:
• full information regarding CI(s)
• precaution to be observed in its administration and
• use.
• warning statements as required and/or specified by FDA
→ “flammable”
→ “ for external use only”
→ “keep out of reach of children”
if contents of a container are to be used in one occasion only:
• “single use only”
• single dose”
• “use only once”
• “discard any remaining portion”
• or any statement to that effect

H. INTERACTIONS
label shall include drug interactions:
→ drug-drug
→ drug-food
→ drug-laboratory
• alcohol when present in the product shall also be → other relevant interactions
indicated expressed as percentage (%)
I. ADVERSE DRUG REACTIONS
• alcohol without qualification = ethyl alcohol
• coloring, antimicrobial and antioxidant agents and
• label shall include detailed information on adverse drug
reaction(s) for a drug product arranged by system organ
preservatives that may cause hypersensitivity and/or
class
ADRs also be indicated
→ amount expressed in the same manner as the API
J. OVERDOSE AND TREATMENT
E. INDICATIONS • label shall include signs and symptoms of overdose, as
well as possible treatment
• shall include only the FDA-approved clinical use(s) of
the drug product
J. STORAGE CONDITION(S)
F. DOSAGE AND MODE OF ADMINISTRATION • label shall indicate appropriate storage condition(s) and
shall contain full information on the product’s recommended special instructions for handling of the drug product
dosage:
SPECIAL LABELING INSTRUCTIONS:
• initial or loading dose
Properties Special Labeling Instructions
• optimal use or usual dose cannot tolerate refrigeration “do not refrigerate or freeze”
• frequency interval cannot tolerate freezing “do not freeze”
• duration of treatment light-sensitive “protect from light””
cannot tolerate excessive heat store and transport not above
• dosage adjustment
(e.g. suppositories) 30 ̊c”
• other pertinent aspects of drug therapy, if applicable hygroscopic “store in dry conditions”
other relevant information:
• dilution – specific volume of diluent K. PACK SIZE AND NET CONTENT
• reconstitution UNIT CARTON
• preparation • indicate pack size in terms of number of units in the
pack or volume of each unit
• administration
→ ex: liquids – 60 ml
→ suspensions - “shake well before use”
→ tablets – 10 blister packs x 10 tablets
→ tablets with special delivery system – “do not crush”
→ 100 tablets, 12 sachets x 5 g
• description of the reconstituted preparation
 RECONSTITUTED DRUG PRODUCTS – ORAL ADMINISTRATION P. REGISTRATION NUMBER
• volume of the product as reconstituted • label shall indicate the registration number assigned by
FDA to the product
PRIMARY LABEL (EXCLUDING BLISTERS AND FOIL STRIPS) • denoted by a combination of letters and/or numbers
• net content of the product, stating the total
amount/quantity/number of the dosage form in a Q. BATCH NUMBER AND LOT NUMBER
given container shall be expressed in metric units • only batch number shall be indicated if the entire batch
→ ex: liquids – 60 ml sachets 5 g is marketed by one drug establishment
• lot number is indicated if a batch is divided into lots
marketed by different drug establishment
L. NAME AND ADDRESS OF MARKETING AUTHORIZATION
HOLDER
R. EXPIRATION AND DATE OF MANUFACTURE
• label shall state the name and full address of the MAH • expressed as month and year either in:
of the drug product → letters/words and numbers ex: June 2007 or Jun 2007
MARKETING AUTHORIZATION → numbers alone (06/2007)
• an official document issued by Drug Regulatory • if the day is specified, the month shall be spelled out
• authority (DRA) for the purpose of marketing and free → ex: 03 June 2007 or 03 Jun 2007
distribution of product after evaluation for safety, • last day of the month shall be deemed as the date of the
efficacy and quality product’s expiration/manufacturing date.
• Certificate of Product Registration (CPR) • reconstituted products (and administered multiple times)
→ label shall include the period of guaranteed safety,
M. NAME AND ADDRESS OF MANUFACTURER efficacy and quality of the reconstituted preparation
after first opening at a given storage condition(s)
• label shall state the name of the manufacturer and full
address of the specific manufacturing site of the drug
SPECIAL LABELING INSTRUCTION
product as determined by FDA
a. parenteral products
b. fluid replacement products
N. RX SYMBOL AND CAUTION STATEMENT
c. products for external use
RX SYMBOL
→ “FOR EXTERNAL USE ONLY” – red label
• prescription drug products
a. biological products
• prominently displayed b. multivitamin/mineral/herbal products with non-
• allowed to be over-printed or superimposed provided, vitamin/mineral/herbal components
that such will not result in the obliteration by or being c. physician’s sample
rendered less legible than other required labelling d. drugs under MDRP control
information e. reproductive health products
caution statement: MANDATORY INFORMATION
→ “Foods, Drugs, Devices, and Cosmetics Act prohibits A. UNIT CARTON
dispensing without prescription” a. product name
shall always be included in the: b. dosage form and strength
→ package insert, c. pharmacologic category
→ unit carton d. formulation/composition
→ primary label (except blister pack, foil strip, small e. indication (s)
containers of prescription products f. warning(s) (if applicable)
DDPs g. storage condition(s)
h. pack size
• caution statement + additional statement specified by
i. name and address of MAH
PDEA
j. name and address of manufacturer
k. Rx symbol and caution statement - Rx drugs
O.ADR REPORTING STATEMENT
l. ADR reporting statement
Statement:
m. registration number
• For suspected adverse drug reaction, report to the FDA: n. batch number and lot number (if any)
www.fda.gov.ph” o. expiration date and date of manufacture
• statement instructing patient to seek medical attention
immediately at the first sign of adverse drug reaction PRINCIPAL DISPLAY PANEL
shall appear a. product name
→ product information sheet b. dosage form and strength
c. pharmacologic category
→ unit carton
d. pack size
→ primary label (except blister pack, foil strip, small e. Rx symbol and caution statement - Rx Drugs
containers of products intended to be sold without the f. name and complete address of the manufacturer and
unit carton) trader, when applicable
• MAH may include a reporting statement for their own
pharmacovigilance system
 OTHER MANDATORY REQUIREMENTS D.PRIMARY LABEL OF SMALL CONTAINERS
• outside principal display panel SMALL CONTAINERS
• are drug packaging materials that hold less than or equal to 5
mL volume or 5 g weight
includes:
→ ampoules, vials, nebules
→ packaging materials for ophthalmic, otic and nasal liquid
preparation
→ jars and tubes for semi-solid preparations
other packaging material of same capacity:

B. PRIMARY LABEL
except blister pack, foil strip, small containers
a. product name
b. dosage form and strength
c. pharmacologic category
d. formulation/composition
e. indication (s) a. product name
f. warning(s) (if applicable) b. dosage form and strength
g. storage condition(s) c. net content
h. net content d. name and/or logo of MHA
i. name and address of MAH e. Rx symbol (if applicable)
j. name and address of manufacturer f. registration number
k. Rx symbol and caution statement g. storage condition(s)
→ Rx drugs h. batch and/or lot number (if any)
l. ADR reporting statement i. expiration date and date of manufacture
m. registration number
n. batch number and lot number (if any) E. PACKAGE INSERT
o. expiration date and date of manufacture a. Product Name
b. Dosage Form and Strength
PRINCIPAL DISPLAY PANEL c. Pharmacologic Category
a. product name d. Product Description
b. dosage form and strength e. Formulation/Composition
c. pharmacologic category f. Pharmacodynamics and Pharmacokinetic
d. net content g. Indication (s)
e. Rx symbol and Caution Statement h. Dosage and Mode/Route of Administration
➢ Rx Drugs i. Contraindication(s), Precaution(s), Warning(s
f. name and complete address of j. Pregnancy and Lactation (if applicable)
the manufacturer and trader, k. Interactions
when applicable l. Adverse Drug Reaction(s)
other mandatory requirements m. Overdosage and Treatment
→ outside principal display panel n. Storage Condition(s)
o. Dosage Forms and Packaging Available (pack size)
C.BLISTER PACKS OR FOIL STRIPS p. Instructions and Special Precautions for Handling and
• product name of on each unit for single API, or every 2 units Disposal (if applicable)
for multiple APIs q. Name and Address of MAH
r. Name and Address of Manufacturer
• dosage Form and strength of API on each unit for single API,
s. Caution Statement
or every 2 units for multiple APIs
t. ADR Reporting Statement
• name and/or logo of MAH on each unit for single API, or u. Registration Number
every 2 units for multiple APIs (unbranded) v. Date of First Authorization/Renewal of Authorization
• Rx symbol on each unit for single API, or every 2 units for w. Date of Revision of Package Insert
multiple APIs
• batch number and expiration date
→ on every standard blister
pack/foil strip
→ indicated on each unit –
dispensed in qty. less than
the standard blister pack or
foil strip
 F. PATIENT INFORMATION LEAFLET proper and safe administration, use, or storage of the
• information supplied with non-Rx drug products product
• prepared and written in layman's term • administration, use, or storage of the product.
• intended for use by patients
SUMMARY
• complete, readable, neat/ properly placed product
labels are some of the adjectives that a good quality
label should be. This is in accordance with the FDA
regulations on product labelling. Not only that it attracts
the attention of consumers on buying the product but
also a good label should have at least the most
important information of the drug product like its
generic name, dosage form and strength, indication, the
important warnings and precautions on using the drug
a. name of the product product, proper storage conditions and the like
b. description of the product • a good drug packaging must ensure that the drug
c. what is in the medicine? product is stable and still safe upon the consumption of
d. strength of the medicine the patient provided proper storage conditions were
e. what is this medicine used for? also observed
f. how much and how often should you use this medicine? • e.g., . The use of amber bottles for light sensitive
g. when should you not take this medicine? solutions like Vitamin C Syrup
h. care that should be taken when taking this medicine?
• efforts of manufacturing firms for tamper proof
i. undesirable effects of this medicine
packaging also reduced the production of counterfeit
j. what other medicine or food should be avoided while taking
medications
this medicine?
k. what should you do if you missed a dose?
l. signs and symptoms of overdose
m. how should you keep this medicine?
n. what to do when you have taken more than the
recommended dosage?
o. when should you consult your doctor?
p. name and address of MAH
q. name and address of manufacturer
r. ADR reporting statement
s. registration number
t. date of first authorization/renewal of authorization
u. date of revision of patient information leaflet

WHITE/RED/AUXILIARY LABELS
• steps in the hygienic counting of solid dosage units with
the abbot sanitary counting tray
a. placing units from the stock package onto the tray
b. counting and transferring the units to the trough
c. returning the excess units to the stock container
d. transferring the counted units into the prescription
container

RED LABELS
• external use
• based on DOH Administrative Order No. 56, s. 1989
• subject: revised regulations for the licensing of drug
establishments and outlets

WHIATE LABELS
• internal use
• there should be available red and white labels indicating
the name and address of the drugstore

AUXILIARY LABELS
• in addition to the information provided on the typed
label, it is sometimes necessary to use auxiliary labels to
provide supplementary information regarding the