Substitution of Generic Drugs or Interchangeable Biological Products for Brand Name Drugs and Prescribed Biological Products

  1. Law
  2. Georgia Code
  3. Food, Drugs, and Cosmetics
  4. Pharmacists and Pharmacies
  5. Prescription Drugs
  6. Substitution of Generic Drugs or Interchangeable Biological Products for Brand Name Drugs and Prescribed Biological Products

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  1. In accordance with this Code section, a pharmacist may substitute:
    1. A drug with the same generic name in the same strength, quantity, dose, and dosage form as the prescribed brand name drug product which is, in the pharmacist's reasonable professional opinion, pharmaceutically equivalent; or
    2. A biological product with an interchangeable biological product.
  2. If a practitioner of the healing arts prescribes:
    1. A drug by its generic name, the pharmacist shall dispense the lowest retail priced drug product which is in stock and which is, in the pharmacist's reasonable professional opinion, pharmaceutically equivalent; or
    2. A biological product by its nonproprietary name, the pharmacist shall dispense the lowest retail priced interchangeable biological product which is in stock.
  3. Substitutions as provided for in subsections (a) and (b) of this Code section are authorized for the express purpose of making available to the consumer the lowest retail priced:
    1. Drug product which is in stock and which is, in the pharmacist's reasonable professional opinion, both therapeutically equivalent and pharmaceutically equivalent; or
    2. Interchangeable biological product which is in stock.
    1. Whenever a substitution is made, the pharmacist shall record on the original prescription the fact that there has been a substitution and the identity of the dispensed drug product or interchangeable biological product and its manufacturer. Such prescription shall be made available for inspection by the board or its representative in accordance with the rules of the board.
    2. If a pharmacist substitutes a generic drug product for a brand name prescribed drug product when dispensing a prescribed medication, the brand name and the generic name of the drug product, with an explanation of "generic for (insert name of brand name prescribed drug product)" or similar language to indicate substitution has occurred, must appear on the prescription label and be affixed to the container or an auxiliary label, unless the prescribing practitioner indicated that the name of the drug may not appear upon the prescription label; provided, however, that this paragraph shall not apply to medication dispensed for in-patient hospital services or to medications in specialty packaging for dosing purposes as defined by the board.
    3. If a pharmacist substitutes an interchangeable biological product for a prescribed biological product when dispensing a prescribed medication, the name of the interchangeable biological product, with an explanation of "interchangeable biological product for (insert name of prescribed biological product)" or similar language to indicate substitution has occurred, must appear on the prescription label and be affixed to the container or an auxiliary label, unless the prescribing practitioner indicated that the name of the biological product may not appear upon the prescription label; provided, however, that this paragraph shall not apply to biological products dispensed for in-patient hospital services, to hospital administered biological products for outpatients, or to biological products in specialty packaging for dosing purposes as defined by the board. This paragraph shall apply to hospital retail pharmacies and to any biological products dispensed by a hospital for a patient's use or administration at home.
  5. The substitution of any drug or biological product by a registered pharmacist pursuant to this Code section does not constitute the practice of medicine.
  6. A patient for whom a prescription drug or biological product order is intended may instruct a pharmacist not to substitute a generic name drug in lieu of a brand name drug or an interchangeable biological product in lieu of a prescribed biological product.
  7. A practitioner of the healing arts may instruct the pharmacist not to substitute a generic name drug in lieu of a brand name drug or an interchangeable biological product in lieu of a prescribed biological product by including the words "brand necessary" in the body of the prescription. When a prescription is a hard copy prescription drug or biological product order, such indication of brand necessary must be in the practitioner's own handwriting and shall not be printed, applied by rubber stamp, or any such similar means. When the prescription is an electronic prescription drug or biological product order, the words "brand necessary" are not required to be in the practitioner's own handwriting and may be included on the prescription in any manner or by any method. When a practitioner has designated "brand necessary" on an electronic prescription drug or biological product order, a generic drug or interchangeable biological product shall not be substituted without the practitioner's express consent, which shall be documented by the pharmacist on the prescription and by the practitioner in the patient's medical record.
  8. Within 48 hours, excluding weekends and holidays, following the dispensing of a biological product, the dispensing pharmacist or the pharmacist's designee shall communicate to the prescriber the specific product provided to the patient, including the name of the biological product and the manufacturer. The communication shall be conveyed by making an entry into an interoperable electronic medical records system or through electronic prescribing technology or a pharmacy record that is electronically accessible by the prescriber. Otherwise, the pharmacist shall communicate the biological product dispensed to the prescriber by using facsimile, telephone, electronic transmission, or other prevailing means, provided that communication shall not be required where:
    1. There is no interchangeable biological product approved by the federal Food and Drug Administration for the prescribed product; or
    2. A refill prescription is not changed from the product dispensed on the prior filling of the prescription.
  9. The board shall maintain a link on its website to the current list of all biological products determined by the federal Food and Drug Administration to be interchangeable with a specific biological product.
  10. Code Section 26-4-118, "The Pharmacy Audit Bill of Rights," shall apply to biological products and interchangeable biological products dispensed pursuant to this Code section.

(Code 1981, §26-4-81, enacted by Ga. L. 1998, p. 686, § 1; Ga. L. 2004, p. 738, § 6; Ga. L. 2009, p. 8, § 26/SB 46; Ga. L. 2010, p. 266, § 5/SB 195; Ga. L. 2010, p. 554, § 1/HB 194; Ga. L. 2015, p. 1209, § 2/SB 51.)

The 2015 amendment, effective July 1, 2015, in subsections (a), (b), and (c), added the paragraph (1) designation, added paragraph (2), and made related punctuation and grammatical changes; inserted "or interchangeable biological product" in the first sentence of paragraph (d)(1); added paragraph (d)(3); inserted "or biological product" in subsections (e), (f), and (g); inserted "or an interchangeable biological product in lieu of a prescribed biological product" in subsections (f) and (g); inserted "or interchangeable biological product" near the end of subsection (g); and added subsections (h) through (j).

Editor's notes.

- Ga. L. 2004, p. 738, § 1, not codified by the General Assembly, provides that: "This Act shall be known and may be cited as the 'Patient Safe Prescription Drug Act.'"

RESEARCH REFERENCES

ALR.

- Liability of name brand drug manufacturer for injury or death resulting from use of prescription drug's generic equivalent, 56 A.L.R.6th 161.


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