Federal Laws, Regulation, and Pertinent Information

United States Drug Enforcement Administration (DEA)

Transfer of Electronic Prescriptions for Schedules II-V Controlled Substances Between Pharmacies for Initial Filling*

*The final rule amends DEA regulations to explicitly state that an electronic prescription for a controlled substance in schedule II–V may be transferred between retail pharmacies for initial filling on a one-time basis only, upon request from the patient, and clarifies that any authorized refills included on a prescription for a schedule III, IV, or V controlled substance are transferred with the original prescription. The final rule requires that: the transfer must be communicated directly between two licensed pharmacists; the prescription must remain in its electronic form; and the contents of the prescription required by 21 CFR part 1306 must be unaltered during the transmission. The final rule also stipulates that the transfer of EPCS for initial dispensing is permissible only if allowable under existing State or other applicable law.

Section 4(a)(3.1)(ii) of the PA Pharmacy Act states that the prescription being transferred to the pharmacy cannot be for a Schedule II controlled substance. As this language is in the Pharmacy Act a legislative change would need to made should pharmacies in Pennsylvania want to have the ability to transfer prescriptions for Schedule II controlled substances.

United States Food and Drug Administration (FDA)

Code of Federation Regulations, Title 21 – Food and Drugs

Access Title 21 of the Code of Federal Regulations which pertains to Food and Drugs

Code of Federation Regulations, Title 42 – Public Health

Access Title 42 of the Code of Federal Regulations which pertains to Public Health

Compliance with Drug Supply Chain Security Act (DSCSA)

United States Product Safety Commission Poison Prevention Packaging: A Guide for Healthcare Professions

Access a guide on Poison Prevention Packaging

United States Pharmacopeia (USP)

United States Department of Health & Human Services

Access information related to Health Information Privacy and HIPAA

Information on Medicare Part D

Nondiscrimination in Health Programs and Activities

  • The United States Department of Health & Human Services released the Nondiscrimination in Health Programs and Activities Final Rule in May 2016, which took effect on July 18, 2016. Key requirements affecting pharmacies include:
    • Designation of responsible employees
    • Adoption of grievance procedures
    • File assurance of compliance form when applying for federal funding
    • Training
    • Notices of nondiscrimination and taglines
    • Meaningful access for individuals with limited English proficiency
    • Meaningful access for individuals with disability
    • Accessible electronic and information technology programs or activities for individuals with disabilities
    • Reasonable modifications to avoid discrimination on the basis of disability
  • For more information and tips on how to comply, please see this resource from the American Pharmacists Association. Click here for this resource

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Membership in the Pennsylvania Pharmacists Association supports the preservation and advancement of the pharmacy profession in the Commonwealth. Since 1878, we have been working to advance both the profession and patient care.