Big Apple Pharmacy - Limited Compounding Policy

Last Updated: October 04, 2023

 

Purpose:

This policy outlines the procedures and guidelines for limited compounding activities conducted at Big Apple Pharmacy. Limited compounding is defined as the preparation of compounded medications in accordance with federal, state, and local regulations within the scope of our pharmacy's practice.


Scope:

This policy applies to all pharmacists and pharmacy technicians involved in limited compounding activities at Big Apple Pharmacy.


Regulatory Compliance:

Big Apple Pharmacy is committed to complying with all applicable federal, state, and local regulations regarding limited compounding activities, as established by the U.S. Food and Drug Administration (FDA), New York State Board of Pharmacy, and other relevant authorities.


Types of Limited Compounding Activities:

Limited compounding at Big Apple Pharmacy may include, but is not limited to:

  1. Reconstitution of oral suspensions.
  2. Preparation of topical creams, ointments, or gels.
  3. Mixing and flavoring of oral liquids.
  4. Repackaging of commercially available medications in unit-dose packaging.
  5. Preparation of simple suppositories or rectal solutions.
  6. Exclusion: Big Apple Pharmacy will not engage in the compounding of medications that are readily available in the market from commercial pharmaceutical manufacturers. Compounding will only be conducted when a suitable commercially available product is unavailable, or when a compounded medication is specifically requested by a prescriber for a patient with a documented medical necessity.

Personnel Qualifications:

All pharmacists and pharmacy technicians involved in limited compounding activities must meet the required qualifications, including training and certification as applicable.


Procedures:

  • Ingredient Selection: Ensure that all ingredients used in limited compounding are of pharmaceutical grade and comply with applicable monographs and standards.
  • Compounding Process: Follow established procedures for limited compounding activities, including calculations, measurements, mixing, and quality control checks.
  • Quality Assurance: Implement quality control measures to ensure the safety, efficacy, and consistency of compounded medications.
  • Documentation: Maintain accurate and complete records of all limited compounding activities, including batch records, ingredient logs, and quality control documentation.
  • Labeling and Packaging: Properly label compounded medications with patient-specific information, instructions, and appropriate cautionary statements.
  • Storage: Store compounded medications in accordance with stability guidelines and regulatory requirements.
  • Non-Compliance Reporting: Report any instances of non-compliance with this policy to the pharmacy manager or designated compliance officer.
  • Patient Counseling:
  • Pharmacists must counsel patients on the use, storage, and potential side effects of compounded medications as required by regulations and best practices.

Review and Revision:

This limited compounding policy will be reviewed and revised as needed to ensure compliance with changing regulations and to improve the quality and safety of our limited compounding activities.


References:

Federal Food, Drug, and Cosmetic Act (FD&C Act)

New York State Pharmacy Practice Act

United States Pharmacopeia (USP) and National Formulary (NF)

FDA Guidance on Compounding

Other relevant regulatory resources


Effective Date:

This limited compounding policy is effective as of October 4, 2023 and will be reviewed annually or as needed.