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HomeBusiness and Professions CodeDiv. 2Ch. 9Art. 4§ 4076 Prescription Container Labeling Requirements

§ 4076 Prescription Container Labeling Requirements

Business and Professions Code·California
AI Summary·Official Text·Key Terms·Related Statutes·References
AI SummaryVerified

§ 4076 Prescription Container Labeling Requirements

Key Takeaways

  • •Pharmacists must put medicine in the right container with a clear label that includes the drug name, how to use it, the patient's name, the doctor's name, the date, the pharmacy's info, the drug's strength, how much is given, when it expires, and what it looks like (color, shape, etc.).
  • •If a doctor or nurse says not to include some info, the pharmacist can leave it off.
  • •For some special cases, like in hospitals or nursing homes, not all the info is needed on the label.
  • •Pharmacists can give out certain drugs without putting the patient's name on the label if it's for special treatments like expedited partner therapy (EPT) or medication abortion, but they must keep records of these cases.

Example

You go to the pharmacy to pick up your antibiotic for a sore throat.

The pharmacist must give you the medicine in a bottle with a label that has the name of the antibiotic, how to take it (like 'take 1 pill twice a day'), your name, your doctor's name, the date it was filled, the pharmacy's name and address, how strong the medicine is, how many pills are in the bottle, when the medicine expires, and what the pills look like (like 'white, round pills'). If any of this info is missing, the pharmacist is breaking the rules.

AI-generated — May contain errors. Not legal advice. Always verify source.

Official Source
View on CA.gov

§ 4076 Prescription Container Labeling Requirements

(a) A pharmacist shall not dispense a prescription except in a container that meets the requirements of state and federal law and is correctly labeled with all of the following: (1) Except when the prescriber or the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6 orders otherwise, either the manufacturer’s trade name of the drug or the generic name and the name of the manufacturer. Commonly used abbreviations may be used. Preparations containing two or more active ingredients may be identified by the manufacturer’s trade name or the commonly used name or the principal active ingredients. (2) The directions for the use of the drug. (3) The name of the patient or patients. (4) The name of the prescriber or, if applicable, the name of the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6. (5) The date of issue. (6) The name and address of the pharmacy, and prescription number or other means of identifying the prescription. (7) The strength of the drug or drugs dispensed. (8) The quantity of the drug or drugs dispensed. (9) The expiration date of the effectiveness of the drug dispensed. (10) The condition or purpose for which the drug was prescribed if the condition or purpose is indicated on the prescription. (11) (A) Commencing January 1, 2006, the physical description of the dispensed medication, including its color, shape, and any identification code that appears on the tablets or capsules, except as follows: (i) Prescriptions dispensed by a veterinarian. (ii) An exemption from the requirements of this paragraph shall be granted to a new drug for the first 120 days that the drug is on the market and for the 90 days during which the national reference file has no description on file. (iii) Dispensed medications for which no physical description exists in a commercially available database. (B) This paragraph applies to outpatient pharmacies only. (C) The information required by this paragraph may be printed on an auxiliary label that is affixed to the prescription container. (D) This paragraph shall not become operative if the board, prior to January 1, 2006, adopts regulations that mandate the same labeling requirements set forth in this paragraph. (b) If a pharmacist dispenses a prescribed drug by means of a unit dose medication system, as defined by administrative regulation, for a patient in a skilled nursing, intermediate care, or other health care facility, the requirements of this section will be satisfied if the unit dose medication system contains the aforementioned information or the information is otherwise readily available at the time of drug administration. (c) If a pharmacist dispenses a dangerous drug or device in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include on individual unit dose containers for a specific patient, the name of the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1 or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to Section 4052.1, 4052.2, or 4052.6. (d) If a pharmacist dispenses a prescription drug for use in a facility licensed pursuant to Section 1250 of the Health and Safety Code, it is not necessary to include the information required in paragraph (11) of subdivision (a) when the prescription drug is administered to a patient by a person licensed under the Medical Practice Act (Chapter 5 (commencing with Section 2000)), the Nursing Practice Act (Chapter 6 (commencing with Section 2700)), or the Vocational Nursing Practice Act (Chapter 6.5 (commencing with Section 2840)), who is acting within the scope of practice. (e) A pharmacist shall use professional judgment to provide a patient with directions for use that enhance the patient’s understanding of those directions, consistent with the prescriber’s instructions. (f) (1) Notwithstanding subdivision (a) or any other law, a pharmacist may dispense a drug prescribed pursuant to Section 120582 of the Health and Safety Code and label the drug without the name of an individual for whom the drug is intended if the prescription includes the words “expedited partner therapy” or the letters “EPT.” (2) A pharmacist who prescribes, dispenses, furnishes, or otherwise renders EPT, as authorized in subdivision (f), shall not be liable in, and shall not be subject to, a civil, criminal, or administrative action, sanction, or penalty for rendering EPT, if the use of EPT is in compliance with this section, except in cases of intentional misconduct, gross negligence, or wanton or reckless activity. (3) A pharmacist who provides EPT under this section shall provide written notification that describes the right of an individual who receives EPT to consult with a pharmacist about the medication dispensed and additional information regarding possible drug interactions. (g) (1) Notwithstanding subdivision (a) or any other law, a pharmacist may, at their discretion, dispense brand name or generic mifepristone or any drug used for medication abortion without the name of the patient as required in paragraph (3) of subdivision (a), the name of the prescriber as required in paragraph (4) of subdivision (a), or the name and address of the pharmacy as required in paragraph (6) of subdivision (a) if the prescription is labeled with a prescription number or other means of identifying the prescription. (2) A pharmacist who dispenses, furnishes, or otherwise renders brand name or generic mifepristone or any drug used for medication abortion, as authorized in paragraph (1), shall maintain a log with the prescription numbers and the information required in paragraphs (1) to (10), inclusive, of subdivision (a). (3) Notwithstanding Section 4081, all records maintained under paragraph (2) shall not be open to inspection by law enforcement without a valid, court-issued subpoena. (4) This subdivision does not prohibit the investigation of an activity that is punishable as a crime under the laws of this state, provided that records maintained under paragraph (2) are not shared with an individual or entity from another state. (5) A pharmacist shall inform the patient that the pharmacist is dispensing brand name or generic mifepristone or any drug used for medication abortion as authorized by this subdivision. (Amended by Stats. 2025, Ch. 136, Sec. 8. (AB 260) Effective September 26, 2025.)

Last verified: January 22, 2026

Key Terms

prescriptionhospitalpatientphysiciannursingpharmacyexpirationquantity

Related Statutes

  • § 4076.5 Prescription Drug Label Standards
  • § 4076.8 Accessible Prescription Label Requirements
  • § 4128.3 Hospital Unit Dose Prepackaging
  • § 4019 Hospital Drug Order Authorization
  • § 4040 Prescription Order Requirements

References

  • Official text at leginfo.legislature.ca.gov
  • California Legislature. Business and Professions Code. Section 4076.
View Official Source