CHAPTER 5

absorption could occur. Bioavailability of

drugs administered parenterally is usually
more rapid, extensive, and predictable.
Another advantage is that a parenteral
route can be used during emergency
therapy when a patient is unable to take
medications by mouth.
a) Intravenous is a common parenteral
route. Drug absorption is not dependent
on the GI tract and the effects are rapid.
However, rapid administration may
cause hemolysis and other adverse
effects.
b) Intramuscular injections permit the
administration of more irritating drugs
and larger volumes of solutions that
cannot be tolerated by other routes.
c) Subcutaneous (SC or SQ): SC injections
are given under the skin and provide a
rapid onset of action.
d) Transdermal administrations are
applied to the surface of a body part.
4) Inhalation: Inhaled drugs are those that
are administered through mucous
membranes of the respiratory tract by
nebulizer, face mask, pumps, or breathing
machine. Examples of inhaled drugs
include bronchodilators, corticosteroids,
and mucolytic agents.
E. Identify commercially available drug products by
their characteristic physical attributes.
1. Imprint codes
a. Imprint codes are used for quick
identification of solid dosage forms in drug
overdose cases, to identify unknown drug
products, and to allow patients to check that
they have been dispensed the correct
medication. Until 1995, there were no
regulations regarding imprint data on soliddosage forms of medications. Drugs exempt
from federal regulations are in Table 5-1.2
b. The FDA only requires drug firms to provide
their imprint information, along with their
listing forms, to the agencys Drug Listing
Table 5-1

Exemptions to Imprint Code Regulations

Drug products used in

When physical
clinical investigations
characteristics of the
Drug products intended
drug make it impossible
for use in
to imprint
bioequivalence
When the medication is
studies
dispensed in a controlled
Prescribed drug products
health care setting (i.e.,
compounded
doctors office)
extemporaneously by When the drug is not
pharmacists
dispensed to patients
Drugs classified as
for self administration.
radiopharmaceutical
drug products

Dispensing

39

Team, where it is entered into a database.

The data captured include identifiers such as
shape, size, color, imprint code, scoring, and
coating. The database also incorporates
imprint graphics, which describe a logo that
does not consist of conventional characters.
c. For example, tadalafil 10 mg (Cialis) is a
teardrop shaped, yellow tablet imprinted with C
10; tadalafil 20 mg (Cialis) is a teardrop
shaped, yellow tablet imprinted with C 20.
d. The Division of Drug Information can identify
oral-dosage drugs based on physical
appearance and markings. This service offered
by the FDA is free to the American public.
Drug-identification inquiries can be sent to
the Division of Drug Information via telephone
at 888-INFOFDA (888-463-6332), via fax (301-8274577), or via e-mail (druginfo@cder.fda.gov).
e. Dietary supplements are not required to
have imprint information.
2. Packaging and labeling
a. For some medications, the original package is
important to the proper storage of the
medication, or to reference manufacturer
labeling. For example, nitroglycerin sublingual
tablets must be stored in their original, tightly
closed, glass bottle because potency can be lost
by adsorption if repackaged. Packaging can
vary between different strengths or types of
medications.
3. OTC medications: The drug facts label format
was based on the nutrition facts food label. It
uses an easy to read format and includes:
a. The products active ingredients, including
the amount in each dosage unit.
b. The purpose of the medication.
c. The uses and indications for the drug.
d. Specific warnings, including when the
product should not be used, and when it is
appropriate to consult a doctor or
pharmacist. The warnings section also
describes side effects that could occur and
substances or activities to avoid.
e. Dosage instructions addressing when, how,
and how often to take the medication.
f. The products inactive ingredients, which is
important for those with specific allergies.
4. Dietary supplements:
a. The FDA regulates dietary supplements
(defined by the FDA as being composed only
of essential nutrients, such as vitamins,
minerals, proteins, herbs, or similar
nutritional sources) differently than food or
OTC/prescription drug products. Dietary
supplement manufacturers do not have to get
FDA approval or register their products
before producing or selling them. The Dietary
Supplement Health and Education Act of 1994
(DSHEA) states that the dietary supplement
manufacturer is responsible for ensuring that
the supplement is safe before it is marketed.
The FDA is responsible for monitoring safety
via adverse event reporting and product