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Prescription Labels

DEFINITIONS

  • Label: Info on the immediate container and outer packaging
  • Labeling: Includes all printed/pictorial matter on or accompanying the drug/device/cosmetic

PRESCRIPTION LABEL REQUIREMENTS

Must include:

  • Name and address of pharmacy owner
  • Date compounded (filled)
  • Prescription number
  • Prescriber's name
  • Patient's name and address
  • Directions for use

Exemption:

  • At the prescribers request the prescription label for mifepristone or misoprostol shall include the name or address of the prescribing health care practice instead of the name of the prescriber

CONTROLLED SUBSTANCE LABELING REQUIREMENTS

Must include:

  • Name and address of ultimate user
  • If intended for an animal, the species of such animal and the name and address of the owner or person in custody of such animal
  • The name, address and telephone number of the pharmacy
  • Specific directions for use
  • The name of the prescriber
  • Wording “CONTROLLED SUBSTANCE, DANGEROUS UNLESS USED AS DIRECTED”
  • Code number or name of substance
  • An orange label, transparent label or auxiliary label

FEDERAL LABELING REQUIREMENTS FOR CONTROLLED SUBSTANCES

  • The label of any drug listed as a “controlled substance” in schedule II, III, or IV of the Federal Controlled Substances Act shall, when dispensed to or for a patient, contain the following warning: “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”

PO BOXES

  • Address required on controlled substance prescriptions, post office boxes not acceptable

BILINGUAL LABELING

  • Labels may include non-English instructions for patient clarity.
  • Required: All label and pharmacy record information must also appear in English.

This information has been verified numerous times with the Board of Pharmacy.

SHARED PHARMACY SERVICES LABEL REGULATIONS

  • Labels must list all pharmacies involved and their registration numbers.
  • Controlled substances follow additional Public Health Law Article 33 rules.
  • Hospitals are exempt from these labeling requirements.

ACCESSIBLE PRESCRIPTION LABELING

Braille Prescription Labels in the U.S.: Current Status

  • Braille prescription labels are not federally required in the United States, but there are advisory guidelines and state-level efforts aimed at improving accessibility:

Federal Guidelines

  • The FDA Safety and Innovation Act (2012) authorized the U.S. Access Board to develop best practices for accessible prescription labeling, including Braille, large print, and auditory formats like “talking bottles”.
  • These recommendations are advisory only, not mandatory. Pharmacies are encouraged—but not required—to offer Braille labels.
  • lThe FDA has approved Braille labeling on specific drugs, such as Hetlioz, but only when submitted by the manufacturer.

State-Level Legislation

Some states have introduced or passed laws requiring accessible prescription labeling, which may include Braille:

  • California, Colorado, Virginia, Michigan, and Minnesota have passed laws related to accessible labeling.
  • lNew York (S1740) has introduced legislation for accessible prescription labeling, but it’s not yet law as it appears to be in committee at end of session.
  • Other states like Texas, Iowa, Missouri, and Illinois have bills in progress.

Pharmacy Practices

  • Major chains offer accessible options such as ScripTalk (audible labels) and Braille overlays upon request.
  • Pharmacies may partner with others that have Braille embossing capabilities to fulfill occasional requests.

STANDARDIZED LABEL DATA ELEMENTS

Critical Elements (must be bold/color-highlighted, ≥12-point font):

  • Patient name
  • Directions for use (in full sentences)
  • Drug name & strength

Important Elements (legible, not emphasized):

  • Pharmacy name, address, phone
  • Patient address
  • Prescriber name
  • Fill/refill date
  • Prescription number

PRESCRIPTION LABEL TRANSLATION FOR LIMITED ENGLISH PROFICIENT (LEP) INDIVIDUALS

Applies to::

  • Pharmacies part of a group of 8+ in NY under the same corporate ownership

Requirements:

  • Free, competent oral interpretation and translation services
  • Services may be provided by staff or third-party, and must be immediate
  • Notification signage required at drop-off, pick-up, and register areas
    • Must say: “Point to your language. Language assistance will be provided at no cost to you.”
    • Format: 20-point, bold, Arial font

This material is protected by copyright - nyrxlaw - New York Pharmacy Law Resource and Study Guide

LAST UPDATED - JUNE 7, 2026

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