Drug Supply Chain Integrity for Compounding Pharmacies
Beginning July 1, 2015, compounding pharmacies will be required to have a system in place to receive transaction information for the prescription drugs they purchase from suppliers. These requirements are part of the Drug Supply Chain Security Act 1, which replaces individual rules across all 50 states with federal oversight2. In particular, the new rules are part of a 10-year rollout plan that seeks to respond to an evolving international marketplace where problems of drug counterfeiting, drug theft, and substandard drug imports have caused serious problems to patient health and safety.
The first part of the Act, implemented six months ago, required pharmacies to have verification systems in place to handle suspect drugs. The July 1 deadline now further mandates that all healthcare practitioners who dispense or administer prescription drugs must purchase products from authorized, licensed trading partners. Drug dispensers must provide lot-level product-tracing information for a period of six years. This track-and-trace information includes transaction information and history similar to the chain of custody used when investigating standard crimes. If a drug turns out to be problematic, there is a trail of evidence from lot production through to dispensation for any necessary investigation.
Frankly, we need this level of tracking in order to weed out bad manufacturers and suppliers from the ones who provide safe and effective medicines.
How Does This Affect Compounding Pharmacies?
- GMP procedures;
- Usage directions; and
- New drug provisions of the Federal Food Drug and Cosmetic Act.
Compounding pharmacies formulating drugs from bulk APIs, however, must follow other rules:
- Ingredients must be on an approved list issued by the Department of Health and Human Services;
- Ingredients removed from the market as unsafe or not effective, or that appear on a related list published by the HHS, cannot be used;
- Drugs that are unapproved but which essentially identical copies of a commercially available product still may not be compounded; and
- Memorandums of understanding between state and HHS must exist for out-of-state shipments, or such drugs must be limited to 5% of total prescription orders dispensed by the pharmacy.
What Should Compounding Pharmacies Do for Easy Compliance?
Large distributors with online management of their drugs will have an easier time complying than compounding pharmacies, especially those with small, regional distributors. We should take advantage of existing information frameworks to come into compliance. First steps should focus on:
- Relying on the information trail wholesalers have to maintain; and
- Entering into agreements with distributors so the burden of transaction histories is shared or duplicated for backup.
Building up trust with your partners is key, but maintain records at what level you can so that if violations do occur, you can report them quickly. You should also rely on patient reporting to check drug lot problems.
The truth of the matter is that the FDA is not looking to hinder compounding pharmacies but wants to work with us. For example, the agency has recognized that local pharmacies often share their inventory in times of crisis, and that it’s not clear what role individual pharmacies must take to comply with the new rules. The FDA recommends that individual compounding pharmacies and their partners should:
- Provide the FDA with historical data on record keeping, and estimates on future reporting burden versus patient load;
- Discuss with state and federal stakeholders on how best to achieve the single federal database and licensing agency the government wishes to achieve; and
- Understand and seek to equalize the differences in rules for traditional pharmacies versus compounding pharmacies.
The new drug supply chain integrity rules may be confusing at first, but working with wholesalers, distributors, other pharmacies, and the different levels of government will improve patient safety and trust. Eventually, we will level the playing field while providing the safe, effective drugs our patients deserve.
Policy changes and legislation about prescription compounding fluctuate regularly. Pharmaceutica North America is proud to be your resource for the latest news and information, and high-quality, safe bulk compounding materials. Please contact us today to learn more.
- “Drug Supply Chain Integrity,” June 23, 2015, http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity ↩
- “Title II of the Drug Quality and Security Act,” December 16, 2014, http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm376829.htm ↩
- “New Rules for Compounding Drug Products,” February 19, 2014, http://www.uspharmacist.com/content/d/pharmacy_law/c/46717/ ↩
- “FDA Regulation of Compounding Pharmacies: Unsolved Mysteries,” May 14, 2014, http://www.bakerhealthlawupdate.com/2014/05/fda-regulation-of-compounding-pharmacies-unsolved-mysteries/ ↩