Compounding Pharmacy Compliance Program for Independent Pharmacies

Great for non-sterile facilities needing to satisfy Insurance & PBM credentialing.

USP <795> and USP <800> became effective on November 1, 2023.

The state pharmacy boards are the primary enforcement agency in accordance with FDA regulations for the Compounding Compendium. While some state boards have stated they are not going to enforce these standards because the FDA has not provided training or funding, many states are inspecting pharmacies for compliance as USP guidelines are part of the Food, Drug, and Cosmetic Act, federal law.

In states where the state board of pharmacy is not enforcing these rules, if an employee or a patient is injured or worse because of non-compliance, the pharmacy and even the state board of pharmacy are liable. Remember, this all started with the New England Compounding Center.

If you'd like to Stay stress-free and in compliance, we will customize your Non-Sterile Compounding Program with all the tools necessary to meet USP Guidelines, CVS/Caremark, Optium, FDA requirements and ACHC Accreditation. It consists of: 109 policies and procedures, 52 specific forms, 1 plan and 12 reference sources to ensure you are ready and in compliance.

Our Non-Sterile Compounding program has a total of 10 chapters, with a search engine to find what you need, when you need it, monthly task lists ensure the pharmacy maintains compliance, and access to a Project Manager to help keep your files up to date.

How compliant are you?

Do you feel confident you are implementing all regulations required by USP <800> and <795>?
Does your Negative Pressure room's environmental requirements meeting the new standards including storage for all HD ingredients?
Do you know how Hazardous Drug compliance for compounding pharmacies differ from Retail and LTC pharmacy requirements?
Do you have all required Personal Protection Equipment (PPE), including individually fitted respirators (no sharing) based on the SDS of HD ingredients?
Do you have a Policy & Procedure (P&P) manual?
Have your Standard Operating Procedures (SOPs) been updated to reflect your pharmacy's own practices?
Do you know the difference between P&P's and SOPs?
Are you required by state law or insurance carriers to be accredited?

R.J. Hedges is the first to receive ACHC Product Certification for Non-Sterile Compounding

A product can be certified in seven areas, each aligning with a group of ACHC Standards that an organization must adhere to in order to achieve accreditation. These areas include evaluating vendor compliance for administration, operations, fiscal management, human resources, provision of care, and/or quality, and risk management. Certification is not endorsement of a product by ACHC but verification that the product is in compliance with ACHC requirements for that section of the standards.

"From Strategic Partners to Certified Consultants, and now having the 1st Certified Non-Sterile Compounding Program, we are very thankful for these opportunities and excited to see this partnership with ACHC evolve. The review process of our Compounding Program was extensive, we are glad to have their certification to enhance our services and greatly appreciate the benefits they are extending to our clients who choose to seek accreditation. We look forward to additional programs being reviewed for certification in the future and the growth of our partnership"

- Jeff Hedges, R.J. Hedges & Associates CEO

I highly recommend R.J. Hedges & Associates for your pharmacy for pharmacy compliance. It has been very strategic for me to have one place to go for DME, pharmacy, and now compounding accreditation. Jeff's programs gives you peace of mind knowing that you have yourself covered with policies and procedures and compliance programs. All you have to do is make sure you are living by them and you are doing your monthly checklists.The end result is that you are compliant and have the peace of mind needed in today's world. There is too much to know and to go do it alone. I highly suggest giving R.J. Hedges & Associates a try and get compliant.

Devin Trone

Owner of Medicap 8391 & 8362

What does it take to be 100% compliant?
How do we stay up-to-date with changes?
What does 100% customized mean?
How can we talk to a compliance expert?

First and foremost is the desire to be compliant. Compliance isn’t a fun topic and most people don’t like it, however most facilities understand that they have to follow rules and keep up with regulations. If you have the mindset that you are going to get your store in compliance and maintain it, your life will be much easier. At R.J. Hedges, we understand that an owner's day-to-day is often spent balancing thousands of tasks making it difficult to prioritize compliance. We make staying in compliance as simple as possible as we guide you on what you need to know and what you need to do.
Jeff Hedges, President and CEO of R.J. Hedges & Associates is what we like to call a walking compliance encyclopedia. Jeff has an amazing ability to read and dissect laws and turn them into easy-to-understand content and forms. We work with several state and national organizations to ensure that our clients have the most up-to-date resources.
R. J. Hedges & Associates does the hard work for you. Our program has no surprises, no "fill in the blanks". You don’t have to create any policies and procedures, forms, plans etc. Everything is written and documented by the R.J. Hedges & Associates staff and is presented to you in a completed format, ready for implementation. Our extensive knowledge base will enable you to work comfortably through the program and allow you to stay focused on the other areas of running a successful facility.
Our compliance strategists would be happy to schedule an appointment to discuss your compliance questions. They can also provide recommendations on compliance solutions you may already have access to. Click below to sign up and schedule a 1-on-1 session.