Prescription Labeling
Mailing regulations
Controlled substances
Patient package inserts
100

Are a pharmacies name, phone number and address required on a label

Yes!

100

Who are DEA registered dispensers

Pharmacies and doctors

100

Is the NDC number the only required registered number for C1-5 substances.

No DEA number must be visible as well

100

Are oral contraceptives required a package insert, and who regulates it.

Yes they are required, and the FDA regulates it.

200

What must be on the inscription

  • Drug Name: Either the brand name or generic name.
  • Strength/Concentration:
  • Dosage Form
200

Can you mail state medical marijuana

No, it is a schedule one drug on a federal level.

200

What are schedule one drugs.

Drugs that have the highest risk for abuse, and no medical use. No prescriptions are prescribed.

200

Can certain patient package inserts be developed by the manufacturer. If yes who approves it

Yes and then approved by the FDA

300

What is the clear way to write 1 tab po q4-6hr

Instruction for patients must be clearly written or typed out 

Take one tab by mouth every 4 to 6 hours

300

Who overseas safety, packaging, and labeling to ensure prescriptions are dispensed correctly

The FDA

300

For pharmacists to prescribed controlled substance, what must be on the Prescription 

  • Date of issue
  • Patient's name and address
  • Patient's date of birth
  • Clinician name, address, DEA number
  • Drug name
  • Drug strength
  • Dosage form
  • Quantity prescribed
  • Directions for use
  • Number of refills
  • Signature of prescriber
300

When was the patient package insert amended to include more complex information in the package insert

2006

400

Do pharmacies need to have accessible label options in the state of Colorado. 

Yes, As of July 2025

400

What state board creates and enforces state-specific laws on mailing medications

States board of pharmacy

400

Are there refills are schedule two drugs.

No refills. Must have a written or electronic prescription.

400

What act made patient package inserts an requirement.

Federal Food, Drug, and Cosmetic (FD&C) Act

500

What must be labeled on non-oral drugs

For external use only

500

Who enforces pharmacies to follow strict protocols for packaging, documentation, and tracking when shipping these medications.

DEA

500

What Act unified legal framework to regulate certain drugs and other substances that are deemed to pose a risk of abuse and dependence.

The Controlled substance Act

500

What must the package insert include and approved by.

Approved by the FDA and state risks, side effects, and usage instructions.

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