b. The Act requires that the prescription filled in the pharmacy, with the
exceptions noted in paragraph 1-14 below, be dispensed in child-resistant containers.
The requirements below are especially important:
(1) Prescriptions that are not to be refilled. For a prescription that is not to
be refilled, the medication must be dispensed in either a glass or a plastic container with
a child-resistant top.
(2) Prescriptions that are to be refilled. For a prescription that is to be
refilled, the medication must be dispensed in either a glass or a plastic container with a
child-resistant top. If the medication is dispensed in a glass container, a new
child-resistant top must be placed on the container whenever the prescription is refilled.
If the medication is dispensed in a plastic container, upon refilling, the medication must
be placed in a new container with a new child-resistant top. This means that a new
label must be prepared for the refill.
c. The law does not require that the packaging be so difficult to open that all
children are prevented from gaining access to the contents. If this were true, very few
adults could open the package. Therefore, the packaging seen in the pharmacy is a
compromise, it must be too difficult for most children to open and it must be easy
enough for most adults to open.
1-14. EXCEPTIONS TO THE ACT
Some patients (for example, those with arthritis) may find child-resistant
packages too difficult to open. Furthermore, some patients (for example, those with
certain types of heart conditions) must obtain their medications in a hurry when they
need them. For these types of patients, alternatives to child-resistant packaging are
a. Nitroglycerin. Nitroglycerin must NOT be dispensed in child-resistant
packaging. This drug is for patients who have certain types of heart conditions that
require them to obtain their nitroglycerin quickly.
b. Alternative Packaging. For over-the-counter medications, the manufacturer
can market one size of a product in conventional packaging if the same product is also
available in child-resistant packaging. However, the conventional packaging must have
a label that clearly states: "This Package for Households Without Young Children"
or "Package Not Child-Resistant."
c. Patient or Physician Request. The prescribing physician or patient may
request that prescription medicines be put into ordinary packaging without safety
features. Although some pharmacists may ask for a written statement from a patient
before providing a conventional closure, this is not a requirement of the Federal law.