Prescription Label Requirements

Prescription Label Requirements...


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Consider the following:

The main differences between Roman and Arabic numerals are that Roman numerals lack a symbol for zero, and that numeral placement within a number can sometimes indicate subtraction rather than addition.

Legal Requirements of the Prescription Label

(As dispensed to the patient upon a valid prescription order)

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. Caution: Federal Law Prohibits the Transfer of this drug to any other person than for whom it was prescribed.(Controlled Substance Rx’s ONLY)

Not Required on the Rx Label but 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 Drugs

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. The name of the product;

2. The name and address of the manufacturer, packer or distributor;

3. The net contents of the package;

4. The 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.

Labeling of Commercial Containers of Legend Drugs

FDA Regulations require that the label of legend drugs (prescription drugs), as conveyed to the pharmacist, contain the following information:

1. The name and address of the manufacturer, packer or distributor;

2. Ingredient information;

3. A statement of identity-the generic and proprietary names;

4. The quantity in terms of weight or measure applicable to the drug;

5. The net quantity of the package contents ( e.g., 100 tablets);

6. A statement of dosage or a reference to the package insert for dosage information;

7. The expiration date of the drug;

8. The lot number; and

9. The statement "Caution: Federal Law Prohibits Dispensing Without A Prescription".

10.The National Drug Code (NDC number) is requested by FDA and is usually included.

Prescription Labeling

217.015 Definitions for KRS 217.005 to 217.215

(9) The term "label’ means a display of written, printed or graphic matter upon the immediate container of any article; and a requirement made by or under authority of KRS 217.005 to 217.215 that any word, statement, or other information appearing on the label shall not be considered to be complied with unless the word, statement, or other information also appears on the outside container, or wrapper, if any there be, of the retail package of the article, or is easily legible through the outside container or wrapper;

(11) The term "labeling" means all labels and other written, printed or graphic matter:

(a) upon an article or any of its containers or wrappers; or

(b) Accompanying the article;

217.816. Label for prescriptions - Exception.

Every prescription dispensed by a pharmacist in this Commonwealth after July 1, 1972, shall bear upon the label the name of the medication in the container unless the practitioner indicates in the manner of his choice on the prescription "Do Not Label." (Enact. Acts 1972, ch. 126, 3.)

(If the prescriber indicates "Do Not Label" on the Rx, you may not legally place the name of the drug on the label.)

Labeling of Rx When Product Selection (substitution) is Utilized-Board of Rx Ruling

The Kentucky Board of Pharmacy has addressed generic labeling and has come up with the alternatives when product selection is utilized. Alternatives the Board recognizes in lieu of using just the name of the drug dispensed on the label of the prescription container when product selection (substitution) is made are as follows:

1. Methyldopa "generic substitution made for" Aldomet

2. Methyldopa "dispensed in place of" Aldomet

3. Methyldopa "substituted for" Aldomet

4. Methyldopa "generic for" Aldomet

5. Methyldopa "dispensed for" Aldomet

6. Methyldopa "generic as" Aldomet

The label must refrain from wording such as "same as" or any inference that the substitution is the same as the trade name drug. Using only the trade name and the generic name on the label is not acceptable when denoting drug product selection. These alternatives were adopted y the Board to meet the requirement when the physician requests that both names appear on the label. This also should help those pharmacists supplying nursing homes and are required to have the name of the medication as it appears on the physician's order in the chart.

Labeling of Nonprescription Drugs

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. The name of the product;

2. The name and address of the manufacturer, packer or distributor;

3. The net contents of the package;

4. The 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.

Labeling of Commercial Containers of Legend Drugs

FDA Regulations require that the label of legend drugs (prescription drugs), as conveyed to the pharmacist, contain the following information:

1. The name and address of the manufacturer, packer or distributor;

2. Ingredient information;

3. A statement of identity-the generic and proprietary names;

4. The quantity in terms of weight or measure applicable to the drug;

5. The net quantity of the package contents ( e.g., 100 tablets);

6. A statement of dosage or a reference to the package insert for dosage information;

7. The expiration date of the drug;

8. The lot number; and

9. The statement "Caution: Federal Law Prohibits Dispensing Without A Prescription".

10.The National Drug Code (NDC number) is requested by FDA and is usually included.