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Legal Requirements of what Must Be on a Prescription Label


medication bottle label

Prescriptions are medications dispensed to a patient upon submitting a valid prescription order. The pharmacy then produces a label that goes on the medication pack or bottle dispensed.

Info that MUST be on a prescription bottle label:

1. The name and address of the pharmacy
2. The serial number of the prescription
3. The date of the prescription (date of filling or refilling)
4. The name of the prescriber
5. The name of the patient
6. The directions for use, including precautions if indicated
7. The name of the drug and strength, if any
8. The Caution note (controlled substance Rx’s ONLY):
"Federal Law Prohibits the Transfer of this drug to any other person than for whom it was prescribed"

Not required on the Rx label but very common:

1. The address of the patient
2. The initials or name of the pharmacist
3. The telephone number of the pharmacy
4. The manufacturer’s lot number
5. The expiration date of the drug, if any
6. The name of the manufacturer or distributor
7. The quantity of the medication dispensed
8. The number of refills left

Labeling of Nonprescription Drug Containers

Drugs that may be safely used by the average person without medical supervision may be sold without a prescription and are called over the counter drugs. These drugs are usually referred to as OTC’s. OTC’s must bear a label containing specific information.

While OTC labeling requirements are usually associated with the manufacturer, a pharmacist is subject to the same requirements if they remove the drug from its original package and convey it to an ultimate user. (I.E., A patron requests that you sell them 30 Tedral tablets. There are no OTC packages of Tedral in your pharmacy so you take 30 tablets from the stock bottle in the pharmacy and place them in a bottle for sale to the patron. If you do so you must prepare a label that contains everything that the original manufacturers label contained although it does not have to appear exactly the same ). The labeling required on an OTC product includes:

1. Name of the product
2. Name and address of the manufacturer, packer or distributor
3. Net contents of the package
4. Established name of all active ingredients and the quantity of other ingredients whether active or not
5. The name of any habit-forming drug contained in the preparation
6. Cautions and warnings that are needed for the protection of the user
7. Adequate directions for safe and effective use

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