Compounding Pharmacy

PCAB Accreditation Standards require compounding pharmacies to be compliant with all federal, state, local, and nonresident licensure/permit requirements, as applicable.

Copies of current licenses and/or permits, if applicable, must be displayed within public view in a prominent location of the pharmacy and any additional locations or branches.

PCAB Standards

Standard TCRX1-A: The organization is an established entity with legal authority to operate and has a physical location with the appropriate licensure, Articles of Incorporation, or other documentation of legal authority.

The standard applies to an established entity with legal authority to operate that has the appropriate Articles of Incorporation, or other documentation, of legal authority.

Legal authority is granted to one individual, members of a Limited Liability Corporation (LLC), a Board of Directors (usually referred to as the governing body), and as allowed in state statutes for the appropriate type and structure of the organization. The entity, individual, or organization has a copy of the appropriate documentation or authorization to conduct business.

If state or applicable local law requires a license or permit, the organization posts the current copy in a prominent location in all locations/branches and/or in accordance with appropriate regulations or laws. The organization will display all licenses and/or permits required in the pharmacy operation in an area of public view:

  • Resident state board of pharmacy permit/license.
  • Nonresident board of pharmacy permit/license as required, if applicable.
  • Drug Enforcement Administration (DEA) registration.
  • State controlled substance license, if applicable.
  • Pharmacist licenses.
  • Pharmacy Technician licenses/certificates, if applicable.
  • Biohazard generator permit or appropriate contract, as required.

Tips for Compliance

  • In addition to appropriate documentation or authorization to conduct business, compounding pharmacies must post copies of all current federal, state, and local licenses and permits in a prominent location of the pharmacy and ensure they can be viewed by customers.
    • Copies of nonresident licenses/permits must also be posted by compounding pharmacies that ship medications into other states.

Megan Reed, LPhT, CPhT, HDDP, Program Lead, ACHC

Megan is a Certified Pharmacy Technician (2007), who started out her career working at an internship at the CHASS Center, in Detroit, MI.  This experience solidified what she wanted to do in life, which was to help people.  She has worked in two different PCAB Accredited compounding pharmacies.   One designated a 503B Outsourcing Facility.  During that time she was in Quality Assurance, and Lead Technician roles.  Reed diversified during her 14 year career, by also working in hospital outpatient pharmacy.  She is currently the first pharmacy technician hired to work for PCAB (Pharmacy Compounding Accreditation Board).  Reed is also a member of the Pharmacy Clinical Team, at ACHC (Accreditation Commission for Health Care) in Cary, NC.  The main focus of her expertise is in non-sterile, sterile, and hazardous compounding.

Here for You

ACHC is your partner in accreditation. For more information, contact your Account Advisor, email customerservice@achc.org, or call (855) 937-2242, ext. 458.

 

Accreditation Commission for Health Care:  ACHC is excited to give ACA Fellows and Members access to special pricing options and educational resources for their nationally recognized accreditation services. Members can use their unique code to receive a $250 discount off accreditation when submitting an application online at cc.achc.org. They can also use their discount code to receive $50 off when purchasing a workbook or registering for a workshop through www.AccreditationUniversity.com.