PTCB Exam Question and Answer
(Federal Requirements)
"Drug facts" panel must include: active ingredients, purpose, use(s) - indications,
warnings, directions, other information, inactive ingredients, Questions? followed by Ph#
[OTC's without approved application (monograph drugs) require domestic address or
domestic Ph# to receive reports of serious adverse events; drugs with Mg, Ca, Na, or K
that might be harmful to certain pts must have stated exact amount]
Manufacturer Drug Labeling - Answer 1. Name and place of business of manufacturer,
packer, or distributor.
2. National Drug Code number.
3. Adequate directions for use.
4. No misleading statements.
5. Statement of ingredients.
6. Prominence of required label statements.
7. Spanish-language version of certain required statements.
8. Expiration date.
9. Manufacturer lot or control numbers.
10. Declaration of presence of FD&C Yellow No. 5 or No. 6 in certain drugs for human
use
11. Declaration of presence of phenylalanine as a component of aspartame in OTC and
prescription drugs.
12. Prescription drugs containing sulfites, required warning statements.
13. Labeling for systemic antibacterial drug products.
14. Bar code label requirements.
Exceptions or alternatives to labeling requirements for human drug products held by the
Strategic National Stockpile.
Practitioners with Limited Prescribing Authority - Answer 1. Optometrists (OD)
2. MID-level practitioners (PA's, and NP)
- a licensed physician must approve every prescription written by a mid-level
practitioner
DEA Verification - Answer -add the 1st, 3rd, 5th numbers (X).
-add the 2nd, 4th, and 6th numbers (Y).
-multiply Y by 2 to get a new Y
-add X and new Y .
the last number of X+Y should equal the last digit of the DEA number
Is AD1234210 a valid DEA Number? - Answer Yes.
the 1st, 3rd, and 5th number = 6
(Federal Requirements)
"Drug facts" panel must include: active ingredients, purpose, use(s) - indications,
warnings, directions, other information, inactive ingredients, Questions? followed by Ph#
[OTC's without approved application (monograph drugs) require domestic address or
domestic Ph# to receive reports of serious adverse events; drugs with Mg, Ca, Na, or K
that might be harmful to certain pts must have stated exact amount]
Manufacturer Drug Labeling - Answer 1. Name and place of business of manufacturer,
packer, or distributor.
2. National Drug Code number.
3. Adequate directions for use.
4. No misleading statements.
5. Statement of ingredients.
6. Prominence of required label statements.
7. Spanish-language version of certain required statements.
8. Expiration date.
9. Manufacturer lot or control numbers.
10. Declaration of presence of FD&C Yellow No. 5 or No. 6 in certain drugs for human
use
11. Declaration of presence of phenylalanine as a component of aspartame in OTC and
prescription drugs.
12. Prescription drugs containing sulfites, required warning statements.
13. Labeling for systemic antibacterial drug products.
14. Bar code label requirements.
Exceptions or alternatives to labeling requirements for human drug products held by the
Strategic National Stockpile.
Practitioners with Limited Prescribing Authority - Answer 1. Optometrists (OD)
2. MID-level practitioners (PA's, and NP)
- a licensed physician must approve every prescription written by a mid-level
practitioner
DEA Verification - Answer -add the 1st, 3rd, 5th numbers (X).
-add the 2nd, 4th, and 6th numbers (Y).
-multiply Y by 2 to get a new Y
-add X and new Y .
the last number of X+Y should equal the last digit of the DEA number
Is AD1234210 a valid DEA Number? - Answer Yes.
the 1st, 3rd, and 5th number = 6
