When a Drug or Device Deemed Misbranded

  1. Law
  2. Georgia Code
  3. Food, Drugs, and Cosmetics
  4. Standards, Labeling, and Adulteration of Drugs and Cosmetics
  5. When a Drug or Device Deemed Misbranded

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  1. A drug or device shall be deemed to be misbranded:
    1. If its labeling is false or misleading in any particular;
    2. If in package form unless it bears a label containing:
      1. The name and place of business of the manufacturer, packer, or distributor; and
      2. An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count, provided that reasonable variations shall be permitted and exemptions as to small packages shall be established by regulations prescribed by the State Board of Pharmacy;
    3. If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with conspicuousness as compared with other words, statements, designs, or devices in the labeling and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;
    4. If it is for use by man and contains any quantity of the narcotic or hypnotic substance alphaeucaine, barbituric acid, betaeucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marijuana, morphine, opium, paraldehyde, peyote, sulfonmethane, or any chemical derivative of such substance which has been found after investigation by the State Board of Pharmacy to be and by regulations under this chapter designated as habit forming, or any synthetic narcotic or drug unless its label bears the name and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement "Warning - May be habit forming";
    5. If it is a drug and is not designated solely by a name recognized in an official compendium unless its label bears:
      1. The common or usual name of the drug if there is such; and
      2. In case it is fabricated from two or more ingredients, the common or usual name of each active ingredient including the kind and quantity or proportion of any alcohol and also including, whether active or not, the name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetophenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such substance contained therein, provided that to the extent that compliance with the requirements of this subparagraph is impracticable, exemptions shall be established by regulations promulgated by the State Board of Pharmacy;
      1. Unless its labeling bears:
        1. Adequate directions for use; and
        2. Adequate warnings against use by children or in those pathological conditions where its use may be dangerous to health or against unsafe dosage or methods or duration of administration or application in such manner and form as are necessary for the protection of users.
      2. Where any requirement of division (i) of subparagraph (A) of this paragraph as applied to any drug or device is not necessary for the protection of the public health, the State Board of Pharmacy shall promulgate regulations exempting such drug or device from such requirements;
    7. If it is purported to be a drug the name of which is recognized in an official compendium unless it is packaged and labeled as prescribed therein, provided that the method of packing may be modified with consent of the State Board of Pharmacy. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the United States Pharmacopoeia with respect to packaging and labeling unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia;
    8. If it has been found by the State Board of Pharmacy to be a drug liable to deterioration unless it is packaged in such form and manner and its label bears a statement or such precautions as the State Board of Pharmacy shall by regulations require as necessary for the protection of public health. No such regulation shall be established for any drug recognized in an official compendium until the State Board of Pharmacy shall have informed the appropriate body charged with the revision of such compendium of the need for such packaging or labeling requirements and such body shall have failed within a reasonable time to prescribe such requirements;
      1. If it is a drug and its container is so made, formed, or filled as to be misleading;
      2. If it is an imitation of another drug; or
      3. If it is offered for sale under the name of another drug;
    10. If it is dangerous to health when used in the dosage or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof; or
    11. If it is a drug intended for use by man which:
      1. Is a habit-forming drug to which paragraph (4) of this subsection applies;
      2. Because of its toxicity or other potentiality for harmful effect, the method of use, or the collateral measures necessary to its use is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or
      3. Is limited by an effective application under Section 505 of the federal act to use under the professional supervision of a practitioner licensed by law to administer such drug unless it is dispensed only:
        1. Upon a written prescription of a practitioner licensed by law to administer such drug;
        2. Upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist; or
        3. By refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist.
  2. Any drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of this Code section except paragraphs (1) and (9) of subsection (a) of this Code section if the drug bears a label containing the name and address of the dispenser, the serial number and date of the prescription or of its filling, the name of the prescriber, and, if stated in the prescription, the name of the patient and the directions for use and cautionary statements, if any, contained in such prescription. This exemption shall not apply to any drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail or to a drug dispensed in violation of paragraph (11) of subsection (a) of this Code section.

(Ga. L. 1906, p. 83, § 5; Civil Code 1910, § 2104; Ga. L. 1913, p. 44, §§ 1, 2; Code 1933, § 42-110; Ga. L. 1947, p. 1463, § 2; Ga. L. 1961, p. 529, § 10; Code 1933, § 79A-1009, enacted by Ga. L. 1967, p. 296, § 1; Ga. L. 1984, p. 22, § 26; Ga. L. 1985, p. 149, § 26; Ga. L. 2015, p. 5, § 26/HB 90.)

The 2015 amendment, effective March 13, 2015, part of an Act to revise, modernize, and correct the Code, inserted "or" at the end of paragraph (a)(10).

Cross references.

- Deceptive trade practices generally, § 10-1-370 et seq.

Controlled substances and dangerous drugs, T. 16, C. 13.

Code Commission notes.

- Pursuant to Code Section 28-9-5, in 1985, in subparagraph (a)(2)(B), ", provided that" was substituted for "; provided, that" and a semicolon was substituted for a period following "Pharmacy"; in paragraph (a)(4), a comma was deleted following "Pharmacy"; and, in subparagraph (a)(5)(B), a comma was deleted following "such substance".

U.S. Code.

- Section 505 of the Federal Food, Drug, and Cosmetic Act, referred to in subparagraph (a)(11)(C) of this Code section, is codified at 21 U.S.C. § 355.

Law reviews.

- For note, "Does the National Childhood Vaccine Injury Compensation Act Really Prohibit Design Defect Claims?: Examining Federal Preemption in Light of American Home Products Corp. v. Ferrari," see 26 Ga. St. U.L. Rev. 617 (2010). For comment on Givens v. Lederle, 556 F.2d 1341 (5th Cir. 1977) which extends a manufacturer's duty to warn physicians about affects the drugs may have on third person bystanders, see 29 Mercer L. Rev. 643 (1978).

JUDICIAL DECISIONS

Failure to warn claims against generic drug manufacturers not preempted by federal law.

- Trial court erred by dismissing the plaintiff's state-law failure to warn claims asserted against the generic drug manufacturers because the court improperly concluded that those claims were preempted by federal law. PLIVA, Inc. v. Dement, 335 Ga. App. 398, 780 S.E.2d 735 (2015), cert. denied, No. S16C0503, 2016 Ga. LEXIS 234 (Ga. 2016).

RESEARCH REFERENCES

Am. Jur. 2d.

- 25 Am. Jur. 2d, Drugs and Controlled Substances, §§ 19 et seq., 81, 82.

C.J.S.

- 28 C.J.S., Drugs and Narcotics, § 14.

ALR.

- Constitutionality of requirement of disclosure by label of materials or ingredients of articles sold or offered for sale, 57 A.L.R. 686.

Mistake as to chemical or product furnished or misdescription thereof by label or otherwise as basis of liability for personal injury or death resulting from combination with other chemical, 123 A.L.R. 939.

Provisions of statutes against misbranding or false labeling of food, drug, or cosmetic products, as applicable to literature other than that attached to product itself, 143 A.L.R. 1453.

Liability of manufacturer or seller for injury or death allegedly caused by failure to warn regarding danger in use of vaccine or prescription drug, 94 A.L.R.3d 748.

Promotional efforts directed toward prescribing physician as affecting prescription drug manufacturer's liability for product-caused injury, 94 A.L.R.3d 1080.


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