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Threats to Compounded Medicine and What You Can Do

Posted By ANH - Alliance for Natural Health USA, Friday, June 3, 2016

In 2013, Congress passed the Drug Quality and Security Act (DQSA), which tightened federal control over compounding pharmacies.
To implement the law, the FDA is setting guidelines for what can be compounded at “traditional” pharmacies (503A facilities) and outsourcing pharmacies (503B facilities).

In general:

·        503B facilities will only be able to compound drugs that appear on a separate pre-approved list, which has not yet been finalized. Current thinking is that this list will be extremely limited in terms of the needs of integrative physicians. 

·        503A pharmacies are also facing harsh restrictions. DQSA rules limit the substances that can be compounded by traditional pharmacies to those that either 1) have US Pharmacopoeia monographs, 2) are components of approved drugs, or 3) appear on a pre-approved list by the FDA. The FDA is developing a separate “Demonstrably Difficult to Compound List” that will exclude many other important ingredients from compounding.

What is threatened?
Bioidentical Hormones
—Estriol, progesterone, testosterone, and other hormones have been nominated to the “Demonstrably Difficult to Compound” list, meaning that access to compounded hormones is in grave danger.
Supplements—Although many supplements have USP monographs, the FDA has stated that supplements must be pre-approved to be legally compounded. Many supplements and natural ingredients that have been nominated have been rejected, such as curcumin, aloe vera, boswellia, and acetyl-L-carnitine, to name just a few.
IV Nutrients—It is unclear whether the FDA will allow the compounding of nutrient IV bags—especially due to the threats to compounded supplements.
Office Use— The FDA has made it illegal for doctors to keep compounded medications from 503A facilities in their offices without a prescription, a practice known as “office use.” This has increased the cost of these medications, not to mention the added hassle for patients. Medications without prescriptions from 503B facilities can continue, but the list of medications that can be legally compounded by 503B facilities will be limited.
Affordability—Due to the above-mentioned restrictions, and the threat of more to come, it has become extremely difficult for doctors to obtain medications. For example, the price of injectable B-12 has climbed just under 700% from the mid-2000’s.
Interstate Commerce—DQSA limits the amount of interstate shipments that 503A facilities can make to 5% of total sales. This is extremely problematic given that certain pharmacies specialize in specific preparations. A memorandum of understanding released by the FDA increases this amount to 30%, but then states must take over regulatory responsibility over these facilities. Since it is likely that many states will not elect to take on this additional burden, the upshot is 503A facilities will only be able to ship a small portion of their medications out of state, which could create shortages and increase the price of compounded medications further. 

What Can You Do?

·        Follow the developments regarding compounding at ANH-USA.org. 

·        Participate in ANH-USA action alerts that urge lawmakers and regulators to preserve access to compounded medications.

·        Share your story with ANH-USA at http://www.anh-usa.org/contact-anh-usa/

·        Support ANH-USA in its efforts to rein in these excessive, burdensome, and costly regulations at http://www.anh-usa.org/donate/

Tags:  chelation  compounding pharmacy  FDA compounding 

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Compounding Pharmacy Quality Assurance Checklist

Posted By Administration, Tuesday, March 15, 2011
Updated: Friday, April 18, 2014

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Fill006lighted 
Safety and Consistency is Our Priority

There is no compromise when it comes to health.

At McGuff compounding pharmacy, we have independent Quality Assurance and Quality Control programs to ensure that our products and patient care meet high quality standards and requirements. Our commitment is to provide a level of service that delivers safe compounded products consistently that patients and physicians can depend upon.

We use industry leading practices to meet your needs. We model our operations to meet manufacturing FDA Current Good Manufacturing Practice standards whenever possible.

When choosing a compounding pharmacy you want to feel confident that you will receive the highest quality compounded products and unparalleled patient care.

The following are some questions that you should ask when selecting a compounding pharmacy. Each affirmative answer should be followed by one additional question… "If so, how can you prove this to me?". The answer to this question, without independent audit reports of their pharmacy from national and international standards organizations, will more than likely be “because we said so”. If a pharmacy is not accredited by PCAB™ or ISO there must be a reason.:

Quality Assurance Checklist

 

TopicQuestionMcGuff Compounding Pharmacy
The Organization Does your pharmacy have specific assignment of quality functional responsibilities as defined in a Quality Assurance plan? Checkmark 
Does your pharmacy have an independent Quality Systems Department whose responsibility is to ensure that the facility, equipment and personnel meet the demanding standards set forth the United States Pharmacopeia? Checkmark 
Does your independent Quality Assurance department have the authority to over-ride the pharmacist-in-charge and stop the release of any compounded medication if the medication quality attributes are suspect? Checkmark 
Independent Standards Reviews Is your pharmacy PCAB Accredited™ which assures that the pharmacy is dedicated to protecting patients by practicing safe, high-quality compounding ? Checkmark 
Is your pharmacy ISO 9001:2008 certified by an independent organization to assure compliance to international standards of customer care and product development? Checkmark 
In addition to your pharmacy license do you have a State Board of Pharmacy sterile compounding license? Checkmark 
The Commitment Is your pharmacy committed to and in compliance with USP <1075>, Good Compounding Practices? Checkmark 
Is your pharmacy committed to and in compliance with USP <795>, Pharmaceutical Compounding – Non-sterile Preparations? Checkmark 
Is your pharmacy committed to and in compliance with USP <797> guidelines for sterile compounding? Checkmark 
Documentation Are all significant procedures performed in the pharmacy covered by Standard Operating Procedures (SOPs)? Is there documentation that the pharmacy staff has been trained and understands the SOPs? Checkmark 
Is the Pharmacy’s Quality Assurance plan reviewed annually and when changes are made to the plan? Checkmark 
Does the pharmacy maintain both a master formula and lot-specific compounding history records for all compounds? Checkmark 
Does the pharmacy's master formula document the name, strength, and dosage form of the compounded product, all ingredients and their quantities, assigned a beyond-use date, record the equipments to be used, mixing instructions, packaging instructions, and Quality Assurance checklist? (This documentation ensures that the compound is prepared consistently to reproduce the same each and every time.) Checkmark 
Does your pharmacy prepare a formulation checklist and perform a design review process to determine acceptable strength, quality, and purity of a new formulation request? Checkmark 
The Facility Does your pharmacy’s facility meet or exceed U.S.P. Guidelines for compounding pharmacies? Checkmark 
Does your pharmacy perform sterile filling in a class 100 (ISO Class 5) laminar flow hood located within class 10,000 (ISO Class 7) clean room? Checkmark 
Does your pharmacy have separate areas dedicated to perform sterile and non-sterile compounding, product inspections, labeling, raw material storage, and dispensing? Checkmark 
Is the air quality in your compounding pharmacy engineered for HEPA filtration to reduce particulates? Checkmark 
Environmental Monitoring Does your pharmacy perform daily monitoring and documentation of raw material storage, sterile and non-sterile compounding areas, and final product storage for temperature and humidity? Checkmark 
Does your pharmacy conduct daily tests of air and surface samples of your clean-room and other controlled environments? Checkmark 
Does your pharmacy perform daily, weekly, and quarterly cleaning to assure a clean and safe facility? Checkmark 
Personnel Are your pharmacy’s pharmacists, technicians, and customer service staff dedicated exclusively to compounding? Checkmark 
Is your pharmacy’s staff properly trained to perform aseptic manipulation skills, gowning technique, clean-room use, and successfully perform media fills every six months? Checkmark 
Does your pharmacy’s staff take steps to minimize error and maximize the prescriber’s intent for the patient during the compounding process? Checkmark 
Compounding Materials Does your pharmacy purchase pharmaceutical-grade chemicals (USP, NF equivalent) from FDA-registered suppliers? Checkmark 
Does your pharmacy obtain and keep Certificates of Analysis for all raw materials used in compounding? Checkmark 
Quality Control Does your pharmacy perform sterility testing according to USP <71> - Sterility Tests and USP <85> - Bacterial Endotoxin Test on every lot prepared? Checkmark 
Does your pharmacy verify the potency of finished compounds through weight, volume and yield checks? Checkmark 
Does your pharmacy perform post-filtration filter-integrity testing? Checkmark 
Does your pharmacy have systems in place for handling complaints and investigating sterility failures and adverse events? Checkmark 
Is every step of the compounding process from prescribing to compounding and labeling through dispensing reviewed and verified by a licensed pharmacist Checkmark 

For more information, visit www.mcguffpharmacy.com.

 

Tags:  compounding pharmacy 

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