Poison Prevention Packaging Act (PPPA)

Question 1

Year PPPA act went into place

Answer 1

1970

Question 2

What entity has the authority to require special packaging of “hazardous substances”?

Answer 2

Consumer Product Safety Commission
(CPSC)

Question 3

What is the goal of the PPPA?

Answer 3

The goal is to prevent accidental poisoning in children under five. That statement is
important – this act is only meant to prevent poisonings in children younger than five, which
means four and under.

Question 4

How do you know something is child-resistant?

Answer 4

A package must meet complicated testing
requirements to be considered child-resistant and qualify as special packaging. There are three simplified points to know about special packaging standards.

-First, at
least 90% of adults should easily open the container.

-Second, at least 85% of children under five
who have never seen the kind of packaging undergoing testing and have not been given any
instruction on opening the packaging should not be able to open the container within 5 minutes.

-Third, at least 80% of children under five still cannot successfully open the package within 5
minutes after an adult shows them how to open the container. Pharmacists and others don’t
determine whether something is special packaging or not.

Question 5

What requires child-resistant packaging? (covered products)

Answer 5

• Controlled substances (controlled drugs) in a dosage form intended for oral
  administration (e.g., something a patient swallows).
• Prescription drugs in a dosage form intended for oral administration(e.g., something a
  patient swallows).
• OTC drugs approved after 2002 that were initially prescription products.
• OTC medications intended for oral administration (e.g., something a patient swallows)
  including acetaminophen, aspirin, ibuprofen, loperamide, diphenhydramine, and
  naproxen.
• Sample packages for medications that generally require special packaging.

Question 6

Examples of prescription products not required to be manufactured in CRCs (but it is the responsibility of the pharmacist to ensure they are dispensed in appropriate bottles)

Answer 6

-products in bulk bottles
(e.g., atorvastatin 40mg in a 1000 count bottle)

-products in unit dose containers (e.g.,
ondansetron orally disintegrating tablets [ODT]).

Question 7

Non-oral dosage forms and the PPPA

Answer 7

Drugs not in a dosage form intended for oral administration do not have to be in child resistant
packaging.

Nasal sprays, eye drops, ointments, and other non-oral dosage forms don’t
need to be dispensed in special packaging.

Similarly, drugs intended for topical application to the
teeth or mouth and those products intended for inhalation aren’t considered oral drugs.

This
means one of the first things to consider when determining the type of packing required is the
drug’s dosage form.

There are a handful of OTC exceptions to this rule, specifically around
lidocaine, dibucaine, and minoxidil, but we won’t cover those in this course.

Question 8

Nitroglycerin

Answer 8

Sublingual dosage forms of nitroglycerin.

Question 9

isosorbide dinitrate

Answer 9

Sublingual and chewable forms of isosorbide dinitrate in dosage strengths of 10
milligrams or less.

Question 9

cholestyramine

Answer 9

Anhydrous cholestyramine in powder form.

Question 10

Sodium fluoride

Answer 10

Sodium fluoride drug preparations, including liquid and tablet forms, containing not
more than 110 milligrams of sodium fluoride (the equivalent of 50 mg of elemental
fluoride) per package or not more than a concentration of 0.5 percent elemental
fluoride on a weight-to-volume basis for liquids or a weight-to-weight basis for nonliquids
and containing no other substances subject to special packaging.

Question 10

Erythromycin ethylsuccinate granules

Answer 10

Erythromycin ethylsuccinate granules for oral suspension and oral suspensions in
packages containing not more than 8 grams of the equivalent of erythromycin.

Question 11

potassium supplements

Answer 11

All unit-dose forms of potassium supplements, including individually-wrapped
effervescent tablets, unit-dose vials of liquid potassium, and powdered potassium in
unit-dose packets, containing not more than 50 milliequivalents of potassium per unit
dose.

Question 11

Mebendazole

Answer 11

Mebendazole in tablet form in packages containing not more than 600 mg. of the drug
and containing no other substance subject to special packaging.

Question 11

contraceptives

Answer 11

Cyclically administered oral contraceptives in manufacturers’ mnemonic (memoryaid)
dispenser packages that rely solely upon the activity of one or more progestogen
or estrogen substances.

Question 12

Prednisone

Answer 12

Prednisone in tablet form, when dispensed in packages containing no more than 105
mg. of the drug and containing no other substances subject to special packaging.

Question 12

Pancrelipase

Answer 12

Pancrelipase preparations in tablet, capsule, or powder form and containing no other
substances subject to special packaging.

Question 13

Colestipol

Answer 13

Colestipol in powder form in packages containing not more than 5 grams of the drug
and containing no other substance subject to special packaging.

Question 13

Betamethasone

Answer 13

Betamethasone tablets packaged in manufacturers’ dispenser packages, containing
no more than 12.6 milligrams of betamethasone.

Question 14

Estrogen

Answer 14

Conjugated Estrogens Tablets, USP, when dispensed in mnemonic packages
containing not more than 32.0 mg of the drug and containing no other substances
subject to special packaging.

Question 14

Erythromycin ethylsuccinate

Answer 14

Erythromycin ethylsuccinate tablets in packages containing no more than the
equivalent of 16 grams of erythromycin.

Question 14

Methylprednisolone

Answer 14

Methylprednisolone in tablet form in packages containing not more than 84 mg of the
drug and containing no other substance subject to special packaging.

Question 14

Medroxyprogesterone

Answer 14

Medroxyprogesterone acetate tablets.

Question 14

Norethindrone Acetate

Answer 14

Norethindrone Acetate Tablets, USP, when dispensed in mnemonic packages
containing not more than 50 mg of the drug and containing no other substances
subject to special packaging.

Question 15

Sacrosidase

Answer 15

Sacrosidase (sucrase) preparations in a solution of glycerol and water.

Question 16

HRT

Answer 16

Hormone Replacement Therapy (HRT) products that rely solely upon the activity of
one or more progestogen or estrogen substances.

Question 17

Colesevelam

Answer 17

Colesevelam hydrochloride in powder form in packages containing not more than
3.75 grams of the drug.

Question 18

Sevelamer carbonate

Answer 18

Sevelamer carbonate in powder form in packages containing not more than 2.4 grams
of the drug.

Question 19

All exemptions

Answer 19

1. Sublingual dosage forms of nitroglycerin.
2. Sublingual and chewable forms of isosorbide dinitrate in dosage strengths of 10
   milligrams or less.
3. Erythromycin ethylsuccinate granules for oral suspension and oral suspensions in
   packages containing not more than 8 grams of the equivalent of erythromycin.
4. Cyclically administered oral contraceptives in manufacturers’ mnemonic (memoryaid)
   dispenser packages that rely solely upon the activity of one or more progestogen
   or estrogen substances.
5. Anhydrous cholestyramine in powder form.
6. All unit-dose forms of potassium supplements, including individually-wrapped
   effervescent tablets, unit-dose vials of liquid potassium, and powdered potassium in
   unit-dose packets, containing not more than 50 milliequivalents of potassium per unit
   dose.
7. Sodium fluoride drug preparations, including liquid and tablet forms, containing not
   more than 110 milligrams of sodium fluoride (the equivalent of 50 mg of elemental
   fluoride) per package or not more than a concentration of 0.5 percent elemental
   fluoride on a weight-to-volume basis for liquids or a weight-to-weight basis for nonliquids
   and containing no other substances subject to special packaging.
8. Betamethasone tablets packaged in manufacturers’ dispenser packages, containing
   no more than 12.6 milligrams of betamethasone.
9. Pancrelipase preparations in tablet, capsule, or powder form and containing no other
   substances subject to special packaging.
10. Prednisone in tablet form, when dispensed in packages containing no more than 105
    mg. of the drug and containing no other substances subject to special packaging.
11. Mebendazole in tablet form in packages containing not more than 600 mg. of the drug
    and containing no other substance subject to special packaging.
12. Methylprednisolone in tablet form in packages containing not more than 84 mg of the
    drug and containing no other substance subject to special packaging.
13. Colestipol in powder form in packages containing not more than 5 grams of the drug
    and containing no other substance subject to special packaging.
14. Erythromycin ethylsuccinate tablets in packages containing no more than the
    equivalent of 16 grams of erythromycin.
15. Conjugated Estrogens Tablets, USP, when dispensed in mnemonic packages
    containing not more than 32.0 mg of the drug and containing no other substances
    subject to special packaging.
16. Norethindrone Acetate Tablets, USP, when dispensed in mnemonic packages
    containing not more than 50 mg of the drug and containing no other substances
    subject to special packaging.
17. Medroxyprogesterone acetate tablets.
18. Sacrosidase (sucrase) preparations in a solution of glycerol and water.
19. Hormone Replacement Therapy (HRT) products that rely solely upon the activity of
    one or more progestogen or estrogen substances.
20. Colesevelam hydrochloride in powder form in packages containing not more than
    3.75 grams of the drug.
21. Sevelamer carbonate in powder form in packages containing not more than 2.4 grams
    of the drug.