Exceptions and Exemptions

Question 1

Nitroglycerin

Answer 1

Sublingual dosage forms

Question 2

Isosorbide dinitrate

Answer 2

Sublingual and chewable forms. 10 milligrams or less

Question 3

Erythromycin ethylsuccinate granules

Answer 3

Oral suspensions. No more than 8 grams or the equivalent of erythromycin

Question 4

Erythromycin ethylsuccinate tablets

Answer 4

16 grams of erythromycin

Question 5

Anhydrous cholestyramine

Answer 5

powder form

Question 6

Potassium supplements

Answer 6

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

Question 7

‘Sodium fluoride

Answer 7

liquid and tablet forms, containing no more

than 264 milligrams of sodium fluoride per package.

Question 8

Betamethasone tablets

Answer 8

manufacturers’ dispenser packages containing no more than 12.6 milligrams betamethasone.

Question 9

Mebendazole in tablet form

Answer 9

not more than 600 milligrams of the drug.

Question 10

Methylprednisolone in tablet form

Answer 10

not more than 84 milligrams of the drug.

Question 11

Colestipol in powder

Answer 11

not more than 5 grams of the drug.

Question 12

Pancrelipase preparations

Answer 12

tablet, capsule, or powder form.

Question 13

‘Cyclically administered oral contraceptives

Answer 13

in mnemonic (memory-aid) dispenser packages which rely solely upon the activity of one or more progestogen or estrogen substances.

Question 14

Prednisone in tablet form

Answer 14

no more than 105 milligrams of the drug

Question 15

Conjugated estrogen tablets

Answer 15

dispensed in mnemonic dispenser packages containing not more than 32.0 milligrams

Question 16

Norethindrone acetate tablets

Answer 16

in mnemonic dispenser packages containing not more than 50 milligrams of the drug.

Question 17

Medroxyprogesterone acetate

Answer 17

Tablets

Question 18

Sacrosidase (sucrase)

Answer 18

In a solution of glycerol and water.

Question 19

Hormone Replacement Therapy products

Answer 19

that rely solely upon the activity of one or more progestogen or estrogen substances.

Question 20

A manufacturer or packager may package any over-the-counter household substance (subject to a PPPA standard) in packaging of a single size that does not comply with such standard if:

Answer 20

1. The manufacturer (or packager) also supplies such substance in packages that comply with such standard; and
2. The packages of such substance that do not meet such standard bear conspicuous labeling stating: “This package for households without young children”; (or “Package Not Child-Resistant” for small packages).

Question 21

manufacturers of over-the- counter household products regulated under the PPPA, have the option of marketing one size in a conventional package as long as that same product is supplied in popular-sized complying packages. What is the one exception?

Answer 21

Under the Federal Hazardous Substances Act, household products containing more than 10 percent sodium/potassium hydroxide are banned unless marketed in special packaging.26 The effect of this is to essentially remove the option of producing a single non-complying package of the substance.

Question 22

What is section 4b of the PPP

Answer 22

addresses the need for facilitating access to prescription drugs by elderly and handicapped individuals who have difficulty using special packaging.

“In the case of a household substance which is subject to such a [PPPA] standard and which is dispensed pursuant to an order of a physician, dentist, or other licensed medical practitioner authorized to prescribe, such substance may be dispensed in noncomplying packages only when directed in such order or when requested by the purchaser.”