In the June 3 Federal Register the Food and Drug Administration (FDA) announced it is extending the deadline to submit comments regarding the compounding memorandum of understanding (MOU) draft that appeared in the Federal Register on February 19, 2015. In the previous notice, FDA requested comments on the MOU, ‘‘Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the State of [insert State] and the U.S. Food and Drug Administration’’. The new deadline date for submitting comments is July 20, 2015.
Extending the deadline from June 19 to July 20 is indicative of the complexity and impact of this proposed MOU for states and other stakeholders. Public comments submitted to date can be viewed on the Regulations.gov website. It is anticipated that there will be thousands of comments submitted by the July 20 deadline. What are your thoughts on the MOU? Share you thoughts by clicking below.
If you are currently compounding, or are exploring whether to add compounding to your pharmacy services then this is must reading.
The Drug Quality and Security Act (DQSA) has far reaching implications for compounders, and the regulators who are charged with rulemaking and subsequent enforcement of the DQSA Title I provisions. Still to be finalized is the relationship the FDA will have with individual states and the respective roles FDA and state boards of pharmacy will share in carrying out their responsibilities regarding compounders.
Signed into law on November 27, 2013, the DQSA creates a new section 503B in the Federal Food, Drug, and Cosmetic Act (FDCA). Under section 503B, a compounder can become an “outsourcing facility.” The law defines an “outsourcing facility” as a facility at one geographic location or address that is engaged in the compounding of sterile drugs for human use; has elected to register as an outsourcing facility; and complies with all of the requirements of section 503B. Outsourcing facilities must comply with current good manufacturing practice (CGMP) requirements; they will be inspected by FDA according to a risk-based schedule; and must meet certain other conditions, such as reporting adverse events and providing the FDA with certain information about the products they compound. Outsourcing facilities operating under section 503B are not subject to volume restrictions on interstate distribution.
An outsourcing facility is not required to be a licensed pharmacy and may or may not obtain prescriptions for identified individual patients. FDA clarifies in its guidance that “an outsourcing facility cannot dispense a prescription drug to a patient without a prescription”. The DQSA provides that human drug product compounded by or under the direct supervision of a licensed pharmacist in a registered outsourcing facility can qualify for exemptions from the drug approval requirements in section 505 of the FDCA, the requirement to label products with adequate directions for use in section 502(f)(1) of the FDCA, and the track and trace requirements in section 582 of the FDCA. Under the regulatory framework in states today if an entity fills prescriptions it must be licensed as a pharmacy. Pharmacists and pharmacies are licensed by the states. Because of this licensure authority state boards of pharmacy will have oversight responsibilities at outsourcing facilities.
There are no exceptions to the outsourcing facility meeting CGMP requirements. A pharmacy engaged in compounding is required by the state in which they are licensed to meet that state’s mandated requirements, which are often United States Pharmacopeia (USP) standards. CGMP requirements and USP standards differ, which creates challenges for both compounders and regulators. Compounders who perform patient specific prescriptions and outsourced products at the same location will be inspected to the higher standard of CGMP.
The relationship between the FDA and the individual states is to be determined by a memorandum of understanding (MOU). The statutory basis for the MOU is Section 503A. The law creates a baseline 5% limit on interstate distribution under 503A. Unless the drug product is compounded in a state that has entered into an MOU with the FDA, a pharmacist, pharmacy, or physician cannot distribute or cause to be distributed compounded drug products outside of the state in which they are compounded in quantities that exceed 5% of the total prescription orders dispensed or distributed by that pharmacy or physician. Congress did not intend for compounders operating under the exemptions in section 503A to grow into conventional manufacturing operations making unapproved drugs and operating a substantial portion of their business interstate. If a substantial proportion of a compounder’s drugs are distributed outside of a State’s borders, adequate regulation of those drugs can pose logistical, regulatory, and financial challenges to state regulators.
FDA has proposed a 30% upper limit for pharmacies operating under 503A and located in a state that signs the MOU. On February 19, 2015 the FDA published and made available for public comment the draft standard memorandum of understanding (MOU) entitled “Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the State of [insert State] and the U.S. Food and Drug Administration” The draft standard MOU describes the responsibilities of the state that chooses to sign the MOU in investigating and responding to complaints related to compounded human drug products distributed outside the state and in addressing the interstate distribution of inordinate amounts of compounded human drug products. Individual states are evaluating the draft MOU proposed by the FDA. Public comments on the draft MOU are due by June 19, 2015. Comments on this document are being accepted at Regulations.gov.
For more information about outsourcing facilities and the draft MOU visit the FDA website. If you are a compounder and want to more fully understand your obligations and options please contact us.
When you look at all possible knowledge it can be divided into 3 portions. From the smallest to the largest they are:
- what you know
- what you know you don’t know
- what you don’t know you don’t know
One of the ways you can grow the portion of knowledge that you do know is to invest in you. If you haven’t done so already, invest in a membership to a trade association and a professional organization. Make an investment of your time by attending a national trade show. You’ll be amazed at what you’ll learn. Besides seeing the latest technology and business solutions available, there are many other benefits to attending such an event. Opening your eyes to new possibilities, re-invigorating your enthusiasm, and equipping you with new tools to improve your professional and business skills are just a few of the benefits. These shows are excellent forums to network with peers and other business professionals. You’ll learn from your discussions, and spawn new relationships. Next time you see an advertisement or receive a flyer for one of these trade events, take a second look. These are opportunities to invest in you, your biggest asset.
When you make an investment of money and time to attend a show you are preparing for success. But attending the event does not guarantee success. Be sure you set some goals for yourself, such as finding one to three new ideas that you will implement when you return to work.
Getting away from your everyday business environment for a few days can be one of the most rewarding and refreshing experiences one can encounter. It can make you more proficient when your return, and importantly, better help you appreciate what you don’t know. Better understanding what you don’t know will make you more receptive to seeking and accepting information from experienced professionals who can help you solve your business challenges.
Methamphetamine is the most widely abused domestically produced synthetic drug in the US. The CMEA was passed in 2005, and signed into law in early 2006. The act imposes requirements on sellers including daily sales & monthly limits to purchasers of listed products (ephedrine, pseudoephedrine, or phenylpropanolamine), storage of these listed products behind the counter or in a locked cabinet, confirmation of the identify of purchasers, written or electronic logbook of sales, and retention of the logbook for a minimum of 2 years after date of sale.
Every pharmacy is required to self-certify annually to the Attorney General that each individual who is responsible for delivering such products into the custody of purchasers, or who deals directly with purchasers by obtaining payment for the products, has undergone training provided by the seller to ensure that the individual understands the requirements that apply to the sale of these products. Each separate physical location at which scheduled listed chemical products are sold at retail must be certified. Of note, mail order distributors, defined as a person who makes sales at retail (for personal use but not face-to-face) of scheduled listed chemical products and uses or attempts to use the U.S. Postal Service or any private or commercial carrier to deliver the product to the customer, are also required to self-certify.
The self-certification can be done on line at the DEA website, and the certification printed upon completion of the process. For additional information see http://www.deadiversion.usdoj.gov