Poison Prevention Packaging Act (PPPA) Flashcards
Dispensing a drug product that is not in conformity with the Poison Prevention Packaging Act is which type of violation?
Misbranding
The Poison Prevention Packaging Act of 1970 is enforced by…
Consumer Product Safety Commission
This act requires what type of packaging when dispensing medication directly to the patient?
child-resistant (CR) packaging which must be difficult enough for children under 5 years of age to open (unless the drug is exempt)
Which sublingual drugs are exempt from the PPPA?
(i) sublingual dosage forms of nitroglycerin
(ii) sublingual and chewable forms of isosorbide dinitrate in dosage strengths of 10 mg or less
Which erythromycin ethylsuccinate products are exempt from the PPPA?
(i) granules for oral suspension and oral suspensions in packages containing NMT 8 g of the equivalent erythromycin
(ii) tablets in packages containing NMT 16 g of the equivalent erythromycin
Which bile acid sequestrants are exempt from the PPPA?
(i) anhydrous cholestyramine in powder form
(ii) colestipol in powder form in packages containing NMT 5 g of the drug and no other Rx medication
While steroidal medications are exempt from the PPPA?
(i) betamethasone tablets packaged in manufacturer’s dispenser packages, containing NMT 12.6 mg of bethamethasone
(ii) prednisone in tablet form, when dispensed in packages containing NMT 105 mg of the drug, and containing no other Rx medication
Which oral contraceptives and estrogen/progesterone products are exempt from the PPPA?
(i) cyclically administered oral contraceptives in manufacturer’s mnemonic dispenser packages
(ii) conjugated estrogen tablets, when dispensed in mnemonic packaging containing NMT 32 mg of the drug, and no other Rx medication
(iii) norethindrone acetate tablets, when dispensed in mnemonic packages containing NMT 50 mg of the drug and no other Rx medication
(iv) medroxyprogesterone acetate tablets
Which K supplements are exempt from the PPPA?
those containing NMT 50 mEq of K per unit dose
Which Na fluoride drug preparations are exempt from the PPPA?
those containing NMT 264 mg of NaF per package
Which pancrelipase preparations are exempt from the PPPA?
those in tablet, capsule, or powder form and containing no other Rx medication
Which mebendazole formulation is exempt from the PPPA?
tablet form in packages containing NMT 600 mg of the drug and no other Rx medication
Who is allowed to request non-child-resistant drug containers?
patient and/or the prescriber (there should be some form of a written record of such requests. A patient may change their mind at any time). Also, the prescriber cannot issue a blanket waiver for all Rxs (only the patient).
What constitutes a test failure for unit dose packaging?
When any child opens or gains access to the number of individual units that may produce serious personal injury or serious illness, or, when a child opens or gains access to more than 8 individual units (whichever # is lower)
The PPPA authorizes manufacturers and packers to package such substances in non-complying packaging of a single size provided that:
complying packaging is also supplied and the non-complying packages are conspicuously labeled to indicate that they should not be used in households where young children are present. The label “This package for households without young children” must appear conspicuously on the package. If the area of the principal display panel is too small to accommodate the statement required, the substitute statement, “Package not child-resistant” may be used.
