Pharmaceutical compounding has been a niche of pharmacists for hundreds of years. The practice has become more complex and regulated over time, but it still provides an excellent revenue opportunity for community pharmacies. There are numerous resources available about compounding including how to make it work in your business and how to comply with the myriad of laws and regulations. There are also many different degrees of compounding in a pharmacy setting, from nonsterile creams and tablets to sterile eye drops or other products. As you evaluate how compounding could fit into your current business operation, think about the following:
1. Consider your business. Is your pharmacy a traditional dispensing pharmacy or does it provide additional patient care services? Is there adequate space in the pharmacy for compounding? Do you have sufficient staff to support compounding services?
2. Consider your market. Are there other compounding pharmacies in the area? Are there physicians or veterinarians in the area that prescribe their patients compounded products? Are there enough patients near the pharmacy to support compounding services? What would differentiate your pharmacy over a competitor for compounding services?
3. Consider your customers. Have customers inquired about compounded products before? Does the patient population of your pharmacy frequently require compounded prescription drug products? Would starting compounding at your pharmacy help a significant amount of your patients and/or bring you a significant number of new patients?
Considering your pharmacy and the surrounding environment should give you a good idea of whether compounding services are needed in your area and whether starting them in your pharmacy would be a good decision for your business. Once you have decided to get into compounding pharmacy, you should also consider marketing, operations, management, and finances, as you would any other aspect of your business. Finally, you should become knowledgeable with all state and federal laws and regulations governing the practice of pharmacy as these relate to compounding.
There are many regulations for compounding because when managed improperly, pharmaceutical compounding can cause serious harm to patients. The United States Pharmacopeia (USP) sets standards for compounding which states and/or federal agencies may then choose to enforce. The USP General Chapters on compounding are considered the gold standard and should be adhered to in all compounding pharmacies even if your state has not adopted certain chapters. There are different standards for sterile, nonsterile, and hazardous drug compounding, so whichever you plan to provide in your pharmacy, ensure that you are adhering to all standards that apply. You may be surprised to know that some aspects of General Chapter <800> on hazardous drugs already apply to your pharmacy if your pharmacy supplies and handles even one hazardous drug. The General Chapters are frequently revised, so it is good to keep up with the updates as they come and make sure you are referring to the most recent version of the chapter.
- General Chapter <795> on Pharmaceutical Compounding of Nonsterile Preparations
- General Chapter <797> on Pharmaceutical Compounding of Sterile Preparations
- General Chapter <800> on Hazardous Drugs, Handling in Healthcare Settings
- General Chapter <1160> on Pharmaceutical Calculations in Prescription Compounding
The U.S. Food and Drug Administration provides guidance, compliance, and regulatory information for drug compounding. You should also become familiar with their information surrounding compounding if you want to start compounding services in your pharmacy. Some helpful pages from their website include laws and policies, oversight, and a question and answer page on the basics of compounding and the FDA.
It is important to also check the laws and regulations regarding compounding in pharmacies in your state. There can be some variation between states on things like requirements from the State Board of Pharmacy.
If you are unfamiliar with implementing compounding services or have questions about where to begin, besides contacting NCPA, another resource you may find helpful is the Professional Compounding Centers of America (PCCA). You can find more information about what they do and how they can help at their website, which states that "PCCA is an independent compounding pharmacy's complete resource for fine chemicals, devices, equipment, training, and support."
As you can see, there are many moving parts to implementing compounding services in your pharmacy. However, the impact that doing so can have on your community and your business can make it all worthwhile. Beyond creating a plan for your store, following the guidance, standards, and regulations out there for compounding pharmacy, and potentially joining a compounding association, it is a great idea to get in touch with pharmacists and pharmacy owners who have implemented compounding services in their own stores. It can be incredibly helpful and beneficial to learn from someone who has done it before and has a working knowledge of how to succeed with compounding in a pharmacy. Reach out to contacts with this exposure, or contact us at NCPA and we can connect you with someone who has the knowledge and experience you are seeking.
- Pharmacy Compounding Accreditation Board
- National Institute for Occupational Safety and Health (NIOSH) List of Antineoplastic and Other Hazardous Drugs
- CompoundingToday.com, a website brought to you by the International Journal of Pharmaceutical Compounding
- Compounding 2017 Preview
- USP 800: What you need to know for Community and LTC Pharmacy