How Do You Keep Up (with change)?

Every sector of the health care industry is evolving rapidly. Here are a few current examples. Drug distributors are currently working to implement serialization of products as mandated by the DSCSA to further secure the integrity of the supply chain.  Health care companies who handle, distribute, fulfill, dispense, or administer hazardous pharmaceutical products; and entities who compound non-sterile, sterile, non-sterile hazardous, and sterile hazardous products for administration to patients are feverishly assessing operations, weighing process changes, and finalizing educational components for employees about revised USP 795, USP 797, and USP 800 standards scheduled to take effect December 1, 2019.  The passage of the Farm Bill in late 2018 has caused an explosion of cannabidiol (CBD) product offerings. What CBD products are safe to carry? What are my State’s laws regarding CBD products, and where should I source CBD products?  Retail pharmacy accreditation is receiving renewed interest. Is retail accreditation something I should be pursuing?  How should I prepare for this accreditation?
Admittedly, it’s difficult, if not extremely challenging to balance everyday responsibilities and tasks while still trying to keep abreast of the changes occurring in your business ecosystem. So how DO you keep up with the changes?  Importantly, where do you start?
That’s where PMC can assist you. We provide specialized services in the areas of management, administration, regulatory compliance, and identifying best practices. We assist clients by conducting an internal review of operations to identify potential opportunity areas. Then we collaboratively work with you to implement action plans to bring your operation forward. We help our clients better manage the challenge of staying abreast with market changes and we assist them in matching resources to business needs.
Take that first step to “keep up” and advance your future success. Use the Contact Us page to reach us and request a time to discuss your needs and how we can help.


Is USP <800> Going to Kill Compounding?

July 2018 is rapidly approaching! This is the deadline that USP has set for the implementation of General Chapter <800> Hazardous Drugs-Handling in Healthcare Settings. All compounders of Hazardous Drugs (HDs) are expected to be fully compliant with the standards of USP Chapter <800> as it applies to all personnel who are engaged in handling HDs, including, but not limited to pharmacists, healthcare practitioners and staff, safety specialists, and human resources.

General Chapter <800> addresses:

  • Standards that apply to all personnel who compound HD preparations and all places where HDs are prepared, stored, transported, and administered;
  • Receiving, storing, compounding, dispensing, administering, and disposing of both sterile and nonsterile products and preparations;
  • Altering, counting, crushing and pouring HDs.

Do you know for sure if you are currently handling HDs?  The National Institute for Occupational Safety and Health (NIOSH) maintains the most complete list of anti-neoplastic and other HDs used in healthcare. You must be knowledgeable of these drugs and be prepared to handle and compound preparations according to USP <800> standards. These preparations will no longer be allowed to be prepared in areas that do not meet the standards as prescribed in USP <800>. Compounders must ask themselves if the volume of HD compounding that they perform warrants the associated investments and associated on-going costs.

Are You Ready???
There are many factors to be considered and difficult decisions when contemplating to continue, or even initiate, compounding of preparations that contain hazardous ingredients.  Compounders of HDs will have to completely re-engineer their operations, redesign their compounding labs, invest in new technologies as well as invest in containment, ventilation, HVAC, and personnel protective equipment. Compounders will also be required to develop and implement a comprehensive document of policies and procedures that address all aspects of compounding HDs. Compliance will take substantial investments of financial, spatial and human resources.

In addition to the necessary investments of financial, spatial and human resources, compounders must be prepared to face the challenges that regulatory agencies will present with regards to compliance. USP <800> will be enforceable by federal and state regulatory bodies. Regulatory agencies will inspect HD compounding operations to ensure complete compliance with all of the standards for handling, compounding, storage, delivery, record keeping, documentation, environmental controls, equipment, training, cleaning, safety and disposal of HDs.

No, USP <800> won’t kill compounding. But if you intend to compound HDs you need to analyze where you are in the process. Reach out to us. We are prepared to guide, advise and offer assistance.


USP 800 – A Primer on What You Need to Know

The clock is now running for entities to implement the new USP Chapter <800> Hazardous Drug Handling in Health Care Facilities. General Chapter <800> was published February 1, 2016 and becomes official July 1, 2018. All USP Chapters below <1000> are enforceable by regulatory oversight agencies such as boards of pharmacy, so pharmacies will need to integrate USP <800> requirements into their existing operating practices, and provide mandatory training for employees based on their job functions by July 1, 2018. The chapter applies to all healthcare personnel who handle hazardous drug preparations (e.g. pharmacists, pharmacy technicians, nurses, physicians, physician assistants, home healthcare workers, veterinarians, and veterinary technicians). ‘Handling’ includes the receiving, storing, compounding, dispensing, administering, and disposal of hazardous drugs. A hazardous drug is any drug identified as hazardous or potentially hazardous by the National Institute for Occupational Safety and Health (NIOSH) on the basis of at least one of the following six criteria: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans, organ toxicity at low doses in humans or animals, genotoxicity, and new drugs that mimic existing hazardous drugs in structure or toxicity. NIOSH maintains a list of antineoplastic and other hazardous drugs used in healthcare settings.
Non-compliance with USP <800> will not only leave workers unprotected, but could also potentially harm your pharmacy’s fiscal performance. Penalties, fines, potential legal actions and, ultimately, suspension or termination of license are all potential outcomes of non-compliance.
Your plan of action to fall within compliance should include a thorough study of the chapter, a gap analysis of your current facility’s operations, including equipment, workflow processes, personnel awareness and training; and development of an implementation budget and timeline. For starters, USP is offering a home study course on their education website. With the implementation of <800>, combined with the pending revisions to <797> Pharmaceutical Compounding – Sterile Preparations weighing in the balance, engaging the assistance of experts should be seriously considered. The proposed changes to <797> reflect new science and evidence based on updated guidance documents, best practices, and new learnings from investigations. USP received over 8,750 comments from over 2,500 individuals when the comment period for the <797> revisions closed January 31, 2016.
PMC can assist you with both <797> and <800> from preemptively examining your operation to developing corrective action plans should you get an inspection. We encourage you to address these changes proactively, and engage the assistance of informed experts early rather than having to reactively address cited deficiencies.


FDA Extends Comment Period for Compounding-Related MOU

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.


To Compound or Not to Compound

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.