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503B Outsourcing Facilities – Are You in Compliance?

503B Outsourcing Facilities – Are You in Compliance?

Pharmacy Inspections 503BA lot of discussion about how FDA 503B inspections are having a huge impact on 503B outsourcing facilities and their operations. It’s easy to see that being prepared with your 503B P&P manual up to date is the key to a successful inspection results and compliance audit outcomes. The Drug Quality and Security Act, signed into law on November 27, 2013, created a new section titled 503B in the Federal Food, Drug, and Cosmetic Act. Under section 503B, a pharmacy compounder can become an outsourcing facility by registering with the FDA and paying a fee.

Is Your Facility in Compliance?

Once registered as a 503B, an outsourcing facility must meet specific conditions to be exempt from the Food, Drug & Cosmetics Act’s (FDCA) approval requirements and product labeling requirements. The law requires that all medications and drugs be compounded in compliance with 21 CFR Part 210 and 211 (cGMP), either by or under the direct supervision of a licensed pharmacist in a registered facility.

Are FDA Inspections For 503B Compliance Taking Place?

The FDA began inspecting all 503B facilities based on their risk level assessment. Any deviations from cGMP or other FDA requirements observed during an inspection will be documented on an what’s known as an FDA Form 483 and will lead to further FDA actions (up to and including medication and drug recalls, consent decrees, and formal litigation). Currently, there are seventy-one (71) registered 503B facilities and ALL but two (2) that have been inspected have been issued an FDA Form 483 ( accompanied by recalls of sterile products). The biggest reason for the high level of FDA actions is that the vast majority of compounding pharmacists are not trained in (nor familiar with) cGMP unless they have had significant experience in pharmaceutical manufacturing.

The FDA has recently stated that it intends to continue with their inspections of compounding pharmacies in an attempt to take aggressive actions to protect the public health.

Is Preparing or Responding to an FDA Inspection Complicated?

Preparation for an inspection by the FDA, or corrective action in response to an FDA inspection, requires experts that are well versed in FDA rules and laws, cGMP, and facility design. It is a complicated process that is designed to make sure that medications are safe and effective by making Pharmacies adhere to quality standards when compounding pharmaceuticals.

It is also important to note that the regulations are basically “minimum requirements” and that many Compounding Pharmacies utilize modern technology and documentation approaches that already go well beyond the minimum standards. Equipment, technology and risk management tools in place years ago to prevent errors and contamination may be seen as less than adequate by today’s standards (and by future standards). Basically the Quality Compounding Act of 2013 (QCA) revolves around compliance with the Current Good Manufacturing Practice (CGMP) regulations. The FDA enforces these regulations to assure proper design, monitoring, and control of manufacturing processes and facilities. This then assures the identity, strength, quality, and purity of drugs and medications to the ultimate end-users (patients and consumers). The QCA allows a pharmacy to register as a Section 503B “outsourcing facility” to be exempt from the Food, Drug & Cosmetics Act’s (FDCA) approval and labeling requirements as long as specific conditions are in place and met.

Although this is by no means meant as a comprehensive list, the following basic requirements include:
– Medications must be compounded either by or under the direct supervision of a licensed Pharmacist.
– Medications must be compounded in a registered facility.
– All products and drugs compounded at the facility during any 6 months period must be reported to the FDA.
– A detailed list about the compounded products (including source of ingredients, etc.) must be readily available for inspection.
– Multiple conditions must additionally be met, such as reporting adverse events and labeling products with prescribed information (and must be documented).

Under section 503B, a registered outsourcing facility may only use for compounding a bulk drug substance that is included on an FDA’s established list of bulk drug substances for which there is a clinical need or which are on the FDA’s drug shortage list. Prohibited under sections 503A and 503B is the compounding of drugs that are on a list of drugs that present difficulties for compounding.

Who Can Help With 503B Compliance?

As a national leader in Pharmacy Consulting for over 29 years now, HealthCare Consultants Pharmacy Staffing and Consulting can help you ensure that you are in compliance. This is a team approach and HCC is that team! HCC has experts available with many years of experience in pharmacy compounding, pharmaceutical manufacturing, cGMP design and compliance, and FDA law. Contact HCC to discuss facility and operational assessment, risk mitigation, and corrective action planning.

We urge you to contact us today to see how our Pharmacy Consulting services can help. With a full-time staff of expert in-house Pharmacy Consultant specialists, HCC can answer any questions that you may have in all areas of your business. Contact us online now or call us today at 800-642-1652 for a free consultation.

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USP <800> Pharmacy Compliance

USP <800> Pharmacy Compliance:

Back in March of 2014 the USP (US Pharmacopeial Convention) published yet another intensive set of guidelines regarding the handling of hazardous drugs and their preparation with the release of USP <800> Pharmacy Compliance. Many Pharmacists still remember the 2008 release of the update to USP <797> and we have numerous clients who implemented the changes required for compounding hazardous medications so that the result is a sterile parenteral product. The initial attempt in 2008 was a step in the right direction, but fell short by not having non-parenteral compounding guidelines. Even so, <800> was then hotly debated, criticized and revised. Finally on February 1, 2016, USP <800> was approved. Now implementation of <800> for handling hazardous drugs in all health care settings is a must. Yet after 10 months many Pharmacies and compounding facilities are asking how.

The need for such guidelines is not in question. All prior evidence linked the handling of hazardous drugs to increasing a workers chances for cancer and reproductive issues (as well as the birth defects that have been well documented). Add to this all the media attention over the past few years regarding the FDA and hazardous drug contamination from several specialty pharmacies that resulted in meningitis and patient deaths. The risks of handling hazardous drugs have been known since the early 1980s. The problem that a Pharmacy faces is the never ending changing of these regulations. It has been documented that so far there have been over seventeen guidelines published by six separate Federal agencies and other Healthcare organizations!

Legal Issues –
USP <800> is both a State & Federal standard. What that means is that inspections by both State Boards of Pharmacy and the FDA can cite a Pharmacy for non-compliance. Although compliance is mandatory, the issue is that “current legislation governing sterile product compounding is a patchwork of state-specific regulations with wide variations between jurisdictions” according to a recent article in Pharmacy Times. As the article notes, even though USP <797> is legally enforceable and the industry standard despite state legislation, less than half of state regulations specifically reference USP <797> for sterile compounding.

So far no inspections have occurred that we are aware of regarding USP <800> compliance. However, State Pharmacy Boards have conducted inspections ensuring compliance with USP <797> standards (Florida, California, Texas and Minnesota).

Current legislation governing sterile product compounding is a patchwork of state-specific regulations with wide variations between jurisdictions” according to a recent article published in Pharmacy Times

Actual Changes That Need To Be Implemented ASAP –
Basically USP <800> deals with hazardous drug manufacturing, including such key elements as compounding, preparing the drugs, storage, transport, product storage, compounding, preparation, and administration of parenteral and non-parenteral products. Obviously compliance is mandatory and will be enforced. So the question we all face is: Where do I start?

The core of the changes may actually cause many Pharmacy operations to actually have to change their workflow patterns. Additionally, the equipment specifications may require capital expenditures that will pose a major cash flow problem to many Pharmacy businesses. Although not intended as a legal summary of the USP <800>, here are the key points to focus on:

  1. Compounding, preparing & storing hazardous drugs must occur in an designated area that is separate from areas that non-hazardous drugs are dealt with and stored. Just as an example of the costs that may be involved in being compliant, negative pressure rooms intended for hazardous drug preparation & compounding cannot be used for non-hazardous medication compounding., USP <800> requires pharmacies to utilize a totally separate negative pressure room (plus an additional primary engineering control system) to be compliant!
  2. All hazardous medications are now required to be administered with the use of a CSTD (closed-system transfer device). This is to ensure safety to both nurses who administer the drugs, as well as the patients.

A 2014 study on USP <797> found that many Pharmacies were not compliant. The primary reasons cited were:

  • Financial and budgetary: 27%
  • Physical space limitations: 21%
  • Lack of training resources: 19%
  • Time restraints: 15%
  • Lack of management & leadership support: 5%

So the time to get compliant is now! Don’t put off putting together a Compliance Plan & Strategy until legal issues force you to. As always, please contact us here at HCC if you have any questions regarding this. With over 27 years in the Pharmacy Consulting business, HCC can assist with expert advice in any area of your pharmacy business or practice. We urge you to contact us today to see how our Pharmacy Consulting services can help. With a full-time staff of in-house Pharmacy Consultant specialists, HCC can answer any questions that you may have in all Pharmacy settings. Contact us online or call us today at 800-642-1652 for a free consultation.

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Compliance to USP 797- Pharmacy Compounding Consulting

Compliance to USP 797:

Compliance to USP 797 regarding Pharmacy Compounding is always an important issue for all compounding pharmacies to address as quickly as possible. HCC reported to all specialty compounding pharmacies last year that actions proposed by the Michigan legislature may have been just the beginning of things to come. Directly related to the 2012 meningitis outbreak that has been linked to the now defunct New England Compounding Center (NECC), many states now are considering legislation for additional compliance regulations for compounding pharmacies that even include increased criminal penalties for many violations.

To help our clients and anyone involved in a Pharmacy Compounding business, HCC would like to share the following Risk Level Assessment guide that recently was published in the United States Pharmacopoeia—National Formulary (USP-NF) entitled “USP Tests and Assays Chapter 797, Pharmaceutical Compounding, Sterile Preparations.” This deals with new requirements for the compounding, preparation, and labeling of sterile drug preparations and applies to health care institutions, pharmacies, physician practices, and other facilities that prepare or compound sterile preparations.

Pharmacy Compounding–USP <797> Risk Level Assessment
Risk Category Requirements, Guidance & Examples
  • For emergent use, or situations where low-risk compounding would add risk due to delays
  • No storage or batch compounding
  • Continuous compounding process lasting less than one hour
  • Aseptic technique utilized
  • Administer less than 1 hour after preparation begins, or discard
  • Simple transfer of sterile nonhazardous drugs or diagnostic radiopharmaceuticals
Low-Risk Level
  • Simple admixtures compounded using closed system transfer methods
  • Prepared in ISO Class 5 LAFW
  • Located in ISO Class 7 buffer area with ISO Class 8 ante area
  • Examples include reconstitution of single-dose vials of antibiotics or other small-volume parenterals, preparation of hydration solutions
Low-Risk Level with <12 Hour Beyond Use Date
  • Simple admixtures compounded using closed system transfer methods
  • Prepared in ISO Class 5 PEC
  • Compounding area is segregated from non-compounding areas
  • Administration must start no later than 12 hours after preparation
Medium-Risk Level
  • Admixtures compounded using multiple additives and/or small volumes
  • Batch preparations (e.g., syringes)
  • Complex manipulations (e.g., TPN)
  • Preparation for use over several days
  • Prepared in ISO Class 5
  • Located in ISO Class 7 buffer area with ISO Class 8 ante area
  • Examples include pooled admixtures, parenteral nutrition  solutions using automated compounders, batch-compounded preparations that do not contain bacteriostatic components
High-Risk Level
  • Non-sterile (bulk powders) ingredients
  • Open system transfers
  • Prepared in ISO Class 5
  • Located in ISO Class 7 buffer area with separate ISO Class 8 ante area
  • Examples include CSPs prepared from bulk, nonsterile components or final containers that are nonsterile and must be terminally sterilized


Various studies to date have shown that many compounding pharmacies have been slow to react to the guidelines of US797 regarding compliance. The most often cited reasons include:

– Leadership’s lack of knowledge &/or support
– Financial and budgetary restrictions
– Physical plant limitations
– Lack of available training & competency resources
– Time required to implement changes

If you are a compounding pharmacy, the time to get into compliance is now! Do not let small issues with regulatory compliance turn into serious threats to YOUR pharmacy. Be pro-active regarding the requirements to the USP 797 guidelines. Healthcare Consultants has been helping pharmacies since 1989. Let us help you ensure that your compounding pharmacy has no issues by contacting us today for a complete Compliance Review. Reach us online or call today at 800-642-1652.

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Pharmacy Consulting – What Does King vs. Burwell Decision Mean to Pharmacies?

What King vs. Burwell Decision Means to Pharmacies:

Last week the U.S. Supreme Court voted in favor of upholding one of the primary tenets of the Affordable Care Act in the King vs. Burwell decision. This is the second ruling by the Supreme Court that was in favor of President’s Obama’s health care law. It basically preserved the rights of an estimated 6.4 million US citizens to retain the tax subsidies that help them afford health insurance. It is also seen as a major defeat for the law’s republican opposition, who have been attempting to undermine the law since it went into effect in 2010. The case centered on whether middle and low-income adults who purchased health insurance were entitled to subsidies based on the language of the law that says tax credits are only to be distributed for marketplaces “established by the state.” Many organizations and individuals had feared that there could be chaos in the health insurance market if the Supreme Court had ruled differently. Had the court shot down the tax subsidies, most feared that only the sickest would actually enroll for health insurance, resulting in premiums “skyrocketing” and causing more individuals to dropping their health insurance.

The question many have been asking is how does the ruling affect the Pharmacy profession? The answer is that most are in favor of the decision as it seems to enhance the role of Pharmacists in providing healthcare to patients and stabilizes the pharmacist’s role as a provider of healthcare information and consultant. Here are the responses to the ruling by many Pharmaceutical organizations and associations:

The National Association of Chain Drug Stores (NACDS) noted that pharmacists can play a role in improving patients’ health insurance comprehension. “Pharmacy remains committed to helping patients understand their coverage, which has been a priority throughout the roll-out of exchange-based insurance, as well as to maximizing the valuable role of pharmacies in today’s evolving health care delivery models,” the NACDS wrote. The NACDS also called for pharmacy Medicaid provisions of the ACA to be implemented, allowing for more access to pharmacist-provided patient care.

The Academy of Managed Care Pharmacy CEO Edith A. Rosato, RPh, IOM, praised the King v. Burwell decision, referencing a Kaiser Family Foundation estimate that 6.4 million individuals would have lost subsidies worth $1.7 billion per month if the court had ruled in favor of the plaintiffs. In addition, premiums for subsidized enrollees could have seen massive increases. “Whatever one’s view of the ACA, there’s no denying that this decision has averted significant disruption to the health care marketplace,” Rosato wrote.

The American Society of Consultant Pharmacists (ASCP) does not foresee any changes to the consultant pharmacy profession and long-term care industry as a result of the ruling, but did recognize that the decision adds more certainty to the future of the nation’s health insurance system. “The decision allows our members to continue efforts to work with other professions in the health care arena to deliver higher quality, more cost-effective care to the nation’s seniors,” the ASCP said in a statement.

International Academy of Compounding Pharmacists executive vice president and CEO David G. Miller, RPh, said he also does not expect any changes for the compounding community as a result of the King v. Burwell decision.

Both the Generic Pharmaceutical Association (GPhA) and the International Pharmaceutical Federation (FIP) expressed positive outlooks from the ruling.

As always HCC is here to help you. Healthcare Consulting is a full service Pharmacy Consulting firm that has been in business for over 25 years. HCC has been helping pharmacies plan, prepare and deal with critical business issues since 1989. HCC is owned and operated by pharmacists who are experts in the development and implementation of policies and procedures in all areas of Pharmacy practice. It is also a good opportunity for you to ensure that your pharmacy is in compliance with all state licensing requirements and to have all of your pharmacies’ policies and procedures reviewed by experts! Contact us on line or call us today for a Free Consultation at 800-642-1652 to discuss how we can help you.

Bob Miller

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