U1.4.4^(LO 4.3a, 4.3b). Federal Pharmacy Laws 1906–1962^85^89^,,^5934^6126%
(LO 4.3a, 4.3b)
Federal Pharmacy Laws 1906–1962
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Pure Food and Drug Act of 1906

Prior to 1906, salesmen would travel from community to community selling products to the townspeople. These sales representatives would make promises about their products to the customer without any scientific or medical backing (Figure 4-3). A given product might be used to cure a headache, reduce a fever, kill an infection, settle a stomachache, heal a scar, or make a woman fertile. These products may have been compounded in the back of a home or outdoors. The water may have been secured from a local stream or lake, and the quantities of the ingredients would vary in each batch. Often, the traveling salesmen would cross state lines to sell their products.

Figure 4-3
The Oriental life elixir: a great Egyptian remedy for all diseases.

The Pure Food and Drug Act was enacted in 1906. It required that drugs marketed in interstate commerce meet their professed minimal standards of strength, purity, and quality.

Sherley Amendment of 1912

The Sherley Amendment was enacted to combat fraudulent, false, or misleading claims of therapeutic effects of a medication, which was known as misbranding.

Harrison Narcotic Act of 1914

The government attempted to limit the amount of opium imported into the United States (Figure 4-4). After this date, an individual required a prescription to purchase opium.

Figure 4-4
Interior of opium den, San Francisco, California.
Food, Drug and Cosmetic Act of 1938 (FDCA 1938)

The Pure Food and Drug Act of 1906 required that all drugs be safe before being shipped to other states. As a continuation of the Pure Food and Drug Act of 1906, the Food, Drug and Cosmetic Act of 1938 was enacted. Prior to 1938, the Food and Drug Administration (FDA) did not exist, as we know of it today. Because of this act, the FDA was created (Figure 4-5). The FDA initiated a process that all new drug products must follow in order to be approved. This process included the performance of clinical studies, and required that drug manufacturers submit a New Drug Application (NDA) to the FDA before the drug entity would be approved. A discussion on the process of introducing a new drug product in the United States will be discussed in more detail in Chapter 17.

Figure 4-5
The FDA approves all new drug products.

Any product on the market prior to 1938 did not need these requirements unless petitioned by the FDA. Vitamins and nutritional supplements are not required to undergo this process due to the Dietary Supplement Health and Education Act of 1994 that will be discussed later in the chapter.

The Pure Food and Drug Act of 1906 mentioned adulteration and mis-branding, but neither of these terms were clearly defined until the Food, Drug and Cosmetic Act of 1938 was enacted act.

Adulteration

According to the Federal Food, Drug and Cosmetic Act, adulteration of any drug or drug product includes:

  • Consisting in whole or in part of any filthy, putrid, or decomposed substance

  • Prepared, packed, or held under unsanitary conditions

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  • Prepared in containers composed, in whole or in part, of any poisonous or deleterious substance

  • Containing unsafe color additives

  • Claiming to be or represented as drugs recognized in an official Compendium but differing in strength, quality, or purity of the drugs

Misbranding

According to the Federal Food, Drug and Cosmetic Act, misbranding of a drug is:

  • Labeling that is false or misleading in any way.

  • Packaging that does not bear a label containing the name and place of business of the manufacturer, packer, distributor, or an accurate quantity of contents conspicuously and clearly labeled with information by the act (Figure 4-6).

  • Failing to state Warning—May be habit forming, if the product is habit forming (Figure 4-7).

  • Failing to bear the established name of the drug. In case the drug carries more than two or more active ingredients, the quantities of the ingredients and the amount of alcohol must be included, and also, whether active or not, the established name and quantity of certain other substances described in the act.

  • Failing to label adequate directions for use or adequate warnings against use in certain pathological conditions.

  • Proving dangerous to health when used in the dosage, manner, or duration prescribed, recommended or suggested in the labeling.

Figure 4-6
Drug package information.
Figure 4-7
Display of warning statement.
Labeling

All medications must be labeled properly. If a drug manufacturer or a pharmacy fails to label a medication properly, they are guilty of misbranding (Figure 4-8). A retail pharmacy dispenses prescriptions and therefore the following information is required on a prescription label:

  • Name and address of the pharmacy

  • Prescription number or serial number

  • Date of prescription filling or refilling

  • Name of prescriber

  • Name of patient

  • Directions for use

  • Cautionary statements

Figure 4-8
Medication label.

Medication orders are dispensed to patients in hospitals and long-term care facilities. The labels for a patient's medication in these settings may require different information to appear on the label. It is extremely important that a pharmacy technician working in either a hospital or long-term care facility be familiar with the label requirements of that institution. These requirements may be found in the institution's policy and procedure manual.

Durham-Humphrey Amendment of 1952

The Durham-Humphrey Act of 1952 was an amendment to the Food, Drug and Cosmetic Act of 1938 (FDCA 1938). The Durham-Humphrey Act separated drugs into two categories, legend and non-legend. A legend drug contains the federal legend and requires that the patient be under a physician's care. A legend drug requires a prescription, which is a written directive or order for the preparation and administration of a medication or other remedy.

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Non-legend medications, also referred to as over-the-counter (OTC) medications, medications do not require a physician's supervision, and these products can be purchased without a prescription (Figure 4-9). For a medication to be placed as a legend drug, it must show the following:

Figure 4-9
Over-the-counter (OTC) drugs.
OTC

Examples of OTCs include Tylenol, Benadryl, Robitussin, and Metamucil . The Durham-Humphrey Amendment resulted in the inclusion of the federal legend “Caution: Federal law prohibits dispensing without a prescription” to be included on all prescription medications. At that time, all new medications were classified as prescription medications but could be converted to OTC status later. When this conversion from prescription to OTC status occurred, the medication was formulated at a lower dosage than the prescription medication. Examples of medications being converted from prescription to OTC status included ibuprofen, cimetidine, loperamide, and miconazole and hydrocortisone cream.

An OTC medication's label must include the following:

  • The name of the product

  • The name and address of the manufacturer, packager, or distributor

  • The net contents of the package

  • The established name of all active ingredients, and the quantity of certain other ingredients whether active or not, such as alcohol

  • The name of any habit-forming drug contained in the preparation

  • Cautions and warnings needed for the protection of the user

  • Adequate directions for safe and effective use

If, for some reason, a pharmacy wishes to repackage an OTC medication from a stock bottle, the pharmacy would be required to label the medication exactly as the manufacturer had done. If a physician has written a prescription for an OTC medication, a prescription label may be affixed to the OTC package. If a patient were to ask the pharmacy to place a prescription label on an OTC medication without a valid prescription, the pharmacy cannot do this. It would be a violation of the Food, Drug and Cosmetic Act of 1938, because it would be an example of misbranding.

Prescription or Legend Drugs

All prescription or legend drugs must contain the following information when they are sold to a pharmacy (Figure 4-10):

  • Generic and brand names (drug names will be discussed more in-depth in chapter 5)

  • Ingredient information

  • Weight measure of drug (e.g., 25 mg)

  • Size of container (e.g., 480 mL, 100 tablets, 30 g)

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  • Dosage information or a reference to the package insert for dosage information

  • Manufacturer, packager, or distributor's name and address

  • Expiration date

  • Lot number

Figure 4-10
Prescription drug package.

The Durham-Humphrey Amendment prevented a prescription from being refilled unless it was indicated on the original prescription or authorized from the prescriber. This amendment allowed a prescriber to telephone a prescription into the patient's choice of pharmacy.

Kefauver-Harris Amendment of 1962

The Kefauver-Harris Amendment was enacted because of the marketing of thalidomide in Europe to pregnant women, which resulted in birth defects of their children. These birth defects included disfiguration of the eyes, nose, and ears, and missing limbs. The Kefauver-Harris Amendment requires that all medications (prescription and nonprescription) be pure, safe, and effective. It is the duty of the drug manufacturers to prove that a medication is safe and effective before the FDA will approve it. Any medication marketed between 1938 and 1962 had to show that it was pure, safe, and effective. Medications marketed prior to 1938 were exempted from this act.

Tech Check
  1. Define adulteration and the conditions associated with it. (LO 4.3a)

  2. Define misbranding and the conditions associated with it. (LO 4.3a)

  3. Explain the conditions for a drug to be considered a prescription medication. (LO 4.3b)

  4. What information must be found on the label of an OTC medication? (LO 4.3b)