Leaching – the movement of components of a container - including changes in temperature and the

into the contents. physical stress placed upon the container in

handling and shipping.
- Compounds leached (from plastic containers) –
are generally the polymer additives –plasticizers, Prescription Label
stabilizers, or antioxidants.
Pharmacist must include the following information
- occurs predominantly when liquids / semisolids
on the label of the dispensed medication:
are packaged in plastic.
- occurs when tablets or capsules are packaged in  Name and address of the pharmacy
plastic.  Serial number of the prescription
- Influenced by temperature, excessive agitation  Date of the prescription or the date of its filling /
of the filled container, and the solubilizing effect refilling
of liquid contents on one or more of the polymer  Name of the prescriber
additives.  Name of the patient
- The leaching of polymer additives from plastic  Directions for use (including any precautions, as
containers of fluids intended for intravenous indicated on the prescription)
administration is a special concern that requires
careful selection of the plastic used. In addition, state laws may require additional
- Leached material poses a health hazard to the information:
patient.  Address of the patient
- Studies of the leaching characteristics of each  Initials or name of the dispensing pharmacist
plastic considered for use are undertaken as a  Telephone number of the pharmacy
part of the drug development process.  Drug name, strength, and manufacturer’s lot or
Sorption –used to indicate the binding of molecules to control number
polymer materials, includes both adsorption and  Name of the manufacturer or distributor
absorption.  In an effort to decrease medication errors, there
is thought to include the “indication” on the
- occurs through chemical or physical means due prescription label to help the pharmacist assure
to the chemical structure of the solute molecules the prescribed drug is appropriate.
and the physical and chemical properties of the
polymer. Over-the-Counter Labeling
- Plastic materials with polar groups are FDA – requires a standard format for the
particularly prone to sorption. manufacturers’ labeling of more than 10,000 OTC
- depends on the penetration or diffusion of a products.
solute into the plastic.
- may occur with active pharmacologic agents or In addition to the name of the product, the name
with pharmaceutical excipients. and address of the manufacturer or distributor, the
- may be initiated by the adsorption of a solute to quantity of net contents, the bar code and other product-
the inner surface of a plastic container. identifying items, the expiration date, and other drug-
- The sorption of an active pharmacologic agent specific required information, the following “drug facts”
from a pharmaceutical solution would reduce its must appear in the listed order:
effective concentration and render the product’s  Product’s active ingredients (including the
potency unreliable. amount in each dosage unit)
- The sorption of pharmaceutical excipients such  Purpose of the product
as colorants, preservatives, or stabilizers would  Uses (indications) for the product
likewise alter the quality of the product.  Specific warnings (including when the product
Deformations, softening, hardening, and other physical should not be used under any circumstances and
changes in plastic containers – can be caused by the when it is appropriate to consult with a doctor or
action of the container’s contents or external factors. pharmacist. This section also describes side
 effects that could occur and substances or  “This statement has not been evaluated by the
activities to avoid.) FDA. This product is not intended to diagnose,
 Dosage instructions – when, how, and how often treat, cure, or prevent any disease.”
to take the product
Herbal products – the label must also state the part of the
 Product’s inactive ingredients and important
plant used to make the product (root, stem, or leaf).
information to help consumers avoid ingredients
that may cause an allergic reaction Note: A standardized format provides the patient with
certain minimum information about the product prior to
Note: The format and design of the label are intended to
its use.
be easily read and understood.
U.S. Pharmacopeial Convention (2009)
Dietary Supplement Labeling
- Initiated publication of the USP Dietary
Dietary supplements – products intended to
Supplements Compendium (DSC).
supplement the diet that bear or contain one or more of
the following dietary ingredients: Dietary Supplements Compendium (DSC)
 A vitamin - a collection of standards designed to assist
 A mineral dietary supplement manufacturers in providing
 An herb or other botanical quality products to consumers.
 An amino acid - contains quality specifications for the identity,
 A dietary substance for use by man to strength, purity, and performance
supplement the diet by increasing the total characteristics (e.g., dissolution, disintegration)
dietary intake of dietary supplements included in the
 A concentrate, metabolite, constituent, extract, monographs.
or a combination of any ingredient mentioned
above Storage

FDA’s cGMP guidelines – Manufacturers of dietary - To ensure the stability of a pharmaceutical

supplements must follow these guidelines for dietary preparation for the period of its intended shelf
supplements, including labeling requirements. life, the product must be stored in proper
conditions.
Supplement facts panel - a statement of identity (name - The labeling of each product includes the desired
of the dietary supplement), the net quantity of contents conditions of storage.
statement (amount of the dietary supplement), the - The terms generally employed in such labeling
nutrition values, the ingredient list, and the name and have meanings defined by the USP
place of business of the manufacturer, packer, or
distributor. Cold: Any temperature not exceeding 8°C (46°F).

Dietary Supplement Health Education Act (1994)  Refrigerator - 2°C and 8°C (36°F and
46°F).
- Supplement manufacturers are permitted to  Freezer - 25°C and − 10°C (− 13°F and
make certain label claims. However, the claims 14°F).
must be accurate and truthful.
Cool: Any temperature between 8°C and 15°C (46°F and
× Disease Claims (avoided)- infer or imply that the 59°F).
product can be used to prevent, treat, cure, mitigate, or
diagnose a disease.  “storage in a cool place” is directed
 May alternatively be stored in a
“Structure/function” claims (allowed) – e.g. product refrigerator unless otherwise specified
helps “improve mood” rather than treat depression. in the individual monograph
Permissible claim – the label must also bear the
disclaimer,
Room temperature: A controlled room temperature
encompasses the usual working environment of 20°C to
25°C (68°F to 77°F).

 Also allows for temperature variations

between 15°C and 30°C (59°F and 86°F)
that may be found in pharmacies,
hospitals, and drug warehouses.

Warm: Any temperature between 30°C and 40°C (86°F

and 104°F).

 Excessive heat: Above 40°C (104°F).

Protection from freezing: Where in addition to the risk of

breakage of the container, freezing subjects a product to
loss of strength or potency or to destructive alteration of
the dosage form, the container label bears an
appropriate instruction to protect the product from
freezing.

Transportation

- The stability protection of a pharmaceutical

product during transportation is an important
consideration.
- Temperature and humidity variations may occur
during shipment, \mail order shipment of
prescriptions and their time in the mailbox, and
in emergency care vehicles.
- Transportation to and within geographic areas of
extreme temperatures and humidity requires
special consideration.