Tag Archives: pharmaceutical compounding
Pharmacies that hold a permit in North Carolina and engage in any type of compounding are required to notify the North Carolina Board of Pharmacy (Board).
Pharmacies must report (both on their initial permit application and as part of each annual renewal) the following:
- Whether they compound;
- A good-faith estimate of the percentage of the pharmacy’s dispensing that involves compounded products;
- Whether the pharmacy engages in any non-sterile compounding;
- Whether the pharmacy engages in sterile compounding; and
- What risk level of sterile compounding, as defined by USP <797>, the pharmacy performs.
The Board published a guidance document to reduce any confusion about this reporting requirement.
On June 21, 2016, the Department of Justice announced that two Alabama pharmacists were sentenced to prison terms of 12 and 10 months for their roles in the distribution of adulterated drugs. The drugs in question were compounded at the now-defunct compounding pharmacy Advanced Specialty Pharmacy (dba: Meds IV.)
Meds IV allegedly compounded numerous drugs for human use, including intravenous drugs known as Total Parenteral Nutrition (TPN) which is a liquid nutrition for patients who cannot or should not receive medications orally, without taking the legally required precautions to ensure the sterility of its products.
Allegedly, in early 2011, Meds IV began compounding its own amino acid solution which was then mixed with other intravenous medications to create patient specific TPNs. The amino acids used in compounding the TPNs were adulterated as the amino acids were found to be contaminated with the highly resistant bacteria Serratia marcescens (S. marcescens) which can cause bloodstream infections if introduced into the bloodstream through contaminated medications.
According to documents, the amino acid was prepared by Meds IV outside a laminar airflow workbench and kept unrefrigerated in a non-sterile room in a large pot sitting on the floor before it was sterilized and used.
Nine patients, with other serious underlying medical conditions, who developed bloodstream infections caused by S. marcescens died while many others developed infections but survived.
David Allen of McCalla, Alabama, the former pharmacist-in-charge of Meds IV, was responsible for reviewing and approving TPN formulations, and William Timothy Rogers, of Hoover, Alabama, the former president of Meds IV, pleaded guilty in March 2016 to two misdemeanor violations of the Federal Food, Drug and Cosmetic Act (FDCA). Allen and Rogers received 12 month and 10 month prison terms, respectively, and also received a one year of supervised release following their imprisonment and a $5,000 fine.
The Department of Justice and the Food and Drug Administration continue to work aggressively to protect consumers from drugs compounded under insanitary conditions.
Last week the Food and Drug Administration (FDA) announced three new Draft Guidance documents related to drug compounding under the Sections 503A and 503B of the Food, Drug and Cosmetic Act (FDCA):
- Hospital and Health System Compounding
- Prescription Requirement Under Section 503A
- Clarifying the definition of “Facility” under Section 503B
This article will focus on the Draft Guidance on Hospital and Health System Compounding (Hospital Draft Guidance). The Hospital Draft Guidance explains how Section 503A and 503B apply to hospitals and health systems.
Traditional compounding pharmacies, covered under 503A, are required to obtain valid prescription orders prior to distributing any drug products, amongst other specific requirements.
The new Hospital Draft Guidance clarifies that pharmacies which are part of a hospital or health systems are treated the same under federal law as other traditional compounding pharmacies and are required to comply with the requirements of 503A, unless they are registered as outsourcing facilities.
However, the FDA states it may refrain from enforcing the prescription requirement against hospital-based pharmacies if the compounded drug product is distributed only to facilities under the same ownership and control within a one-mile radius of the pharmacy and administered within the facility pursuant to a patient-specific prescription or order.
The intent of the “one-mile radius” exception is to accommodate centralized drug compounding at a single hospital campus with multiple facilities, but not larger and more geographically diffuse health systems as the FDA remains concerned that distributing compounded drugs across a larger health system is more similar to drug manufacturing.
Hospital pharmacies that wish to distribute compounded drugs outside the one-mile radius without receiving a valid prescription order should, according to the Hospital Draft Guidance, comply with 503B, and register with the FDA as an outsourcing facility or outsource production to an FDA registered outsourcing facility.
Baer Law will have updates on the next two FDA draft guidances shortly.
The FDA recently issued two warning letters to compounders in California and Kentucky for violating current good manufacturing practices related to sterility.
- Producing sterile drug products and putting patients at risk,
- Not receiving valid prescriptions for individually identified patients,
- Misbranded drug products; and
- Poorly written guidelines.
Ionia, in response to the FDA’s noted deficiencies, stated that it would cease all operations and close. The FDA, however, has not received confirmation of Ionia closing.
Inspections at Spoonamore revealed that Spoonamore did not use a sporadical agent as part of its disinfection program in its cleanroom. Additionally, FDA inspectors found that Spoonamore produced domperidone, a medication commonly used to treat nausea and vomiting, that has not been approved by the FDA for use in the United States and therefore should not be used in compounding. Spoonamore reportedly has stopped producing domperidone.
Stay tuned to the Baer Law Blog for more compounding updates.
As the veterinary compounding market continues to grow and expand, new legal issues arise and, in some instances, the current federal and/or state laws may be in conflict with one another or they may not provide clear guidance on specific topics.
Veterinary compounding for ‘office use,’ where a medication is compounded and then sold to a veterinarian, who then administers (or sells) directly to the patient (or owner) remains a hot topic since state authorities continue to regulate compounding and the compounding laws of one state may be completely different from the compounding laws of another state. Thus, it is critical that each veterinary compounding pharmacy familiarize itself with the laws of each state where they do business or face potentially severe disciplinary actions.
Historically, the Food and Drug Administration (FDA), used enforcement discretion that allowed various forms of animal compounding and would defer to state authorities the day-to-day regulation of veterinary compounding by pharmacists, pharmacies and veterinarians. However, the New England Compounding Center (NECC) tragedy of 2012 dramatically changed compounding and, ever since, all aspects of compounding have remained under increased scrutiny.
In response to the NECC compounding tragedy, the FDA stepped in and passed the Drug Quality and Security Act (DQSA) in 2013, which allowed compounding for office use of human drugs if a compounding facility is registered as an outsourcing facility under 503B of the DQSA. In May 2015, the FDA published the Draft Guidance for Industry Compounding Animal Drugs from Bulk Substances (Draft Guidance) which states that while 503A and 503B provide certain statutory exemptions for compounded human drugs these sections do not provide exemptions for drugs compounded for animal use. Unfortunately, neither has sufficiently addressed office use of compounded medications for animals and, thus, the regulation of veterinarian compounding remains under state authorities.
For veterinary compounding pharmacies, issues with individual state law regulation remain as one state may expressly prohibit compounding for ‘office use’ or make no distinction between human drugs and animal drugs, while others laws simply do not address ‘office use.’
In conclusion, veterinary compounding pharmacies should continue to pay close attention to the specific ‘office use’ laws of each state where they send compounded veterinary medications as it is highly likely that their actions will continue to be closely monitored and scrutinized.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI) #230 entitled “Compounding Animal Drugs from Bulk Drug Substances.” The draft guidance describes FDA’s policies with regard to compounding animal drugs from bulk drug substances. When final, the guidance will reflect FDA’s current thinking on the issues addressed by the guidance.
FDA is also announcing the withdrawal of the compliance policy guide (CPG) entitled “Section 608.400 Compounding of Drugs for Use in Animals,” which was issued in July 2003. This 2003 CPG is being withdrawn because it is no longer consistent with FDA’s current thinking on the issues it addresses.
The Drug Quality and Security Act (DQSA) amends the Federal Food, Drug and Cosmetic Act (FDCA) with respect to human drug compounding. As discussed previously on the Baer Law Blog, Title I of the DQSA amended Section 503A of the FDCA and added Section 503B. Sections 503A and 503B address exemptions from certain FDA requirements for compounding pharmacies regarding medications for human use.
In short, DQSA does not apply to veterinary compounding and the Food and Drug Administration (FDA) has confirmed as much through its July 2014 Guidance, stating, “Section 503A does not apply to drugs intended for use in animals,” since the laws and regulations governing compounding human medications differ from the laws and regulations governing veterinary compounding.
Veterinary compounding is generally regulated by state boards of pharmacies. The FDA has historically deferred to these state authorities regarding the day-to-day regulation of compounding by pharmacists and veterinarians of animal and human drugs that are intended for use in animals. However, the FDA retains some enforcement discretion regarding activities that are related to drug manufacturing.
The FDA intends to offer new policy guidance to address veterinary compounding once the results of its study on the compounding of drugs for use in animals is available and has been reviewed. Stay tuned to the Baer Law Blog for updates.
Baer Law recently completed an analysis of thirty-two (32) separate disciplinary actions against Colorado Prescription Drug Outlets (PDOs) by the Colorado State Board of Pharmacy (Board).
The Board registers and licenses pharmacy businesses, both in-state and out-of-state, including:
- Prescription Drug Outlets;
- Wholesale distributors of prescription drugs;
- Manufacturers of prescription drugs;
- Other outlets; and
- Limited licenses.
The Board has jurisdictions over PDOs, or in-state pharmacies, pursuant to provisions of the Pharmacists, Pharmacy Businesses, and Pharmaceuticals Act at Title 12, Article 42.5, C.R.S (Article 42.5) and Board of Pharmacy Rules and Regulations (3 CCR 719-1).
PDOs failure to timely address repeated deficiencies and not promptly reporting changes in the status of a pharmacist-in-charge are of particular interest, not only because over fifty percent of the disciplinary cases analyzed involved one or both of these issues and resulted in fines ranging from $1000 to $10,000, but that, in most instances, the fines could have been avoided had the PDOs promptly addressed the prior documented deficiencies.
Issues addressing changes in the status of a pharmacist-in-charge will be discussed in the next Baer Law blog.
Baer Law identified three recent cases that resulted in probation and large fines simply because repeated deficiencies were never addressed or corrected. Again, it is important to note that had these deficiencies been promptly addressed each PDO could have avoided fines, probation and the burden of continued monitoring.
In the first case, during a routine inspection, the Board discovered six repeated deficiencies from previous Board inspections, including:
- Vaccine administration records not in compliance;
- Casual sales records that were not in compliance;
- Labeling on non-sterile compounded products made in anticipation of orders not in compliance with Board Rules;
- Return of stock records not in compliance;
- A compounded product was assigned a beyond use date that exceeded the expiration date of the individual component; and
- Compounding records did not accurately reflect the date a compounded product was prepared.
Additionally, the Board found five dispensing errors and discrepancies between what the prescriber’s directions for use were and what was placed on the patient’s prescription label. Ultimately, the Board placed the Pharmacy on five years probation with numerous strict stipulations on monitoring.
In the second case, the Board identified seven repeated deficiencies from previous inspections which included:
- Invoices not in compliance with Board rules;
- Notice of initial interpretation and final evaluation posting not in compliance with Board rules;
- Prescription files were not maintained in three (3) different prescription files: Schedule II, Schedule III-V, and non-controlled substance prescription orders;
- Beyond use dating for non-sterile compounded products were not in compliance with Board rules;
- The labeling non-sterile compounded products did not comply with Board rules;
- The labeling of anabolic steroid prescriptions were not in compliance with Article 42.5 rules; and
- Four prescriptions orders were filled without valid DEA numbers on the orders.
In the final case, a pharmacy was fined for nine repeated deficiencies including:
- Pharmacist manager immunization training documentation that could not be located;
- Prepack records for cassettes that did not include the name or initials of the pharmacist responsible for packaging;
- Vaccine records that did not include, among other things, the site of administration;
- Invoices for prescription drugs that were not dated upon receipt;
- Compounding records for non-sterile compounded products that did not contain appropriate beyond-use dating;
- A compounding record for a non-sterile aliquot preparation that did not include the date of preparation;
- The policy and procedure manual for central processing could not be located;
- Electronic storage of controlled substance prescriptions is not allowed; and
- Transferred prescription orders did not include, among other things, the phone number of the transferring outlet, first fill date and last fill date.
For these repeated violations, the Board fined the Pharmacy $3000 and placed the Pharmacy on probation.
Colorado PDOs must take notice when the Board identifies a deficiency. PDOs must make a conscious effort to promptly address all documented Board deficiencies to avoid any future fines or disciplinary actions. Failure to do so, as documented in these three cases, could result in probation, significant fines and continued close monitoring by the Board.
In conclusion, by ignoring the Board’s recommendations, each PDO is placing the health, safety and welfare of the citizens of Colorado at risk, which is clearly unacceptable.
Until recently, the State of Georgia did not require non-resident pharmacies to obtain a license to ship medications into the State of Georgia. However, at the Georgia Board of Pharmacy’s (GBOP) September 2014 meeting, the GBOP enacted rules requiring non-resident pharmacies to obtain a non-resident pharmacy license before dispensing medications into the State of Georgia.
On October 1, 2014, the GBOP posted the GBOP approved application for non-resident pharmacy licensure. The cost for this license is $1,000 and each license must be renewed yearly. Non-resident pharmacies interested in obtaining non-resident pharmacy licensure need to fill out this GBOP non-resident pharmacy application and return it to the GBOP.
Non-resident pharmacies should be prepared to provide at a minimum:
- Proof of a valid pharmacy license in their resident state,
- The name, titles and addresses of all principal corporate officers and the pharmacist in charge of dispensing drugs to residents of Georgia, and
- A statement affirming the applicant is in compliance with all lawful directions and requests for information from the regulatory or licensing agencies of each state where the applicant is licensed.
- A copy of the most current inspection report (i.e. no more than six months) from a licensing agency in its jurisdiction if a non-resident pharmacy is conducting sterile or non sterile compounding.
Applicants should expect a minimum of one month for application processing, though this estimate will likely take much longer initially due to the large number of applications the GBOP is expected to receive this month. Therefore, with a target date for enforcement of the new requirement less than three months away — on January 1, 2015 — non-resident pharmacies should ensure their applications are timely filed.
Please contact Baer Law with any questions regarding the new Georgia non-resident pharmacy requirements.
Baer Law Firm, LLC
John Paul Baer, PharmD, JD
25521 E. Smoky Hill Road, Suite #120
Aurora, CO 80016
Beginning October 1, 2014, Florida requires all non-resident pharmacies to obtain a Nonresident Sterile Compounding Permit in order to ship, mail, deliver or dispense in any manner, a compounded sterile product into the State of Florida.
Nonresident pharmacies that are compounding sterile products under their current Florida pharmacy permit may continue to do so if:
- The product meets or exceeds the standards for sterile compounding in this state;
- The product is not compounded in violation of any law or rule of the state, territory, or district where the pharmacy is located; and
- The pharmacy is issued the new Nonresident Sterile Compounding Permit on or before February 28, 2015.
Nonresident Sterile Compounding Permit applicants will also be required to demonstrate full compliance with Chapter 797 of the United States Pharmacopeia, (USP 797).
The State of Florida further stresses that applications must be received by January 15, 2015 to ensure a license may be issued prior to the February 28, 2015 deadline. The application is available at http://floridaspharmacy.gov/licensing/
As a reminder, effective November 27, 2013, pharmacies are now only permitted to ship patient-specific sterile compounded products, or they must be in full compliance with 21 United States Code, (U.S.C.) § 353b, which includes being registered as an Outsourcing Facility.← Older posts