Tag Archives: 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.
On April 15, 2016, the FDA issued draft guidance on the Prescription Requirement Under 503A (Prescription Guidance). The Prescription Guidance sets forth the FDA’s policy concerning prescription requirements for compounding human drug products for identified individual patients under Section 503A of the Federal Food, Drug and Cosmetic Act (FDCA) and addresses:
- Compounding after the receipt of a prescription for an identified individual patient,
- Compounding before the receipt of a prescription for an identified individual patient (anticipatory compounding) and
- Compounding for “office use”
The Prescription Guidance notes that a valid prescription order for a compounded product must be received from a licensed physician or other licensed practitioner authorized by state law to prescribe drugs before dispensing a compounded drug.
In addition, the policy notes that a pharmacist may consult with the prescriber to determine whether the patient needs a compounded drug and make appropriate notations on the prescription order. Such notations, which would serve as the basis for compounding under Section 503A, must include the prescriber’s determination that a compounded drug is necessary for the identified patient.
The FDA recommends using the following statement:
“Per [type of communication] with [name of prescriber] on [date], [name of prescriber] has advised that compounded [name of drug] for the treatment of [name of patient].”
The Prescription Guidance does recognize the statutory authority to engage in “anticipatory compounding,” or the practice of compounding drugs in advance of receiving a valid prescription order based on the historical needs and relationship between a licensed pharmacist and the prescriber.
However, FDA notes that the “limited quantity” restriction regarding anticipatory compounding would likely be interpreted as a limit of a 30-day supply based on the relationship.
Finally, the Prescription Guidance addresses office use, or the practice of shipping compounded drugs to hospitals, clinics and physician offices in advance or without first obtaining a prescription for an individual patient.
The FDA acknowledges that hospitals, clinics and health care practitioners have valid needs for office stock and office use compounded drug products to administer to patients who present with an immediate need for a compounded drug product. However, the the FDA notes that such compounded products can be obtained from FDA outsourcing facilities registered under Section 503B or via anticipatory compounding in a limited quantity provided a patient-specific prescription order is presented for the compounded drug product.
Up next: Analysis on the third FDA draft guidance which clarifies the definition of “Facility” under Section 503B.
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.
Last month the Food and Drug Administration (FDA) alerted health care professionals and patients not to use drug products intended to be sterile that are produced and distributed by IV Specialty of Austin, Texas, due to lack of sterility assurance.
The FDA found numerous safety issues during its February 2016 which prompted them to recommend that IV Specialty (1) cease sterile production until appropriate corrective action are implemented and (2) recall all non-expired drug products intended to be sterile.
IV Specialty is a small pharmacy that reportedly only compounds in response to physician orders and does not provide medicines for office use or ship out of state. The FDA’s inspection report, Form 483, lists IV Speciality as a “Producer of Sterile Drug Products” and not as a licensed “Outsourcing Facility.” Therefore, some question whether the FDA has authority to force IV Specialty to halt production or issue a recall.
In response to the FDA alert a consumer advocacy group, Public Citizen, urged the Texas State Board of Pharmacy (Texas Board) to suspend IV Specialty’s compounders license since the FDA “uncovered multiple egregious, life-threatening problems in the company’s processes for making sterile drugs.”
In response to the FDA alert and Public Citizen’s pleas, the Texas Board sent one of its inspectors to IV Specialty and ultimately determined that there was not an immediate danger to the public or anything that would prompt the Texas Board to immediately close the pharmacy.
The Texas Board, however, acknowledged that while state regulations are not as stringent as FDA regulations, they are closely monitoring the case since the Texas Board recently issued five warning notices to IV Specialty for different violations. Additionally, the Texas Board has been in close contact with the FDA regarding their concerns.
As discussed previously on the Baer Law Blog, historically, state boards of pharmacy regulated compounding pharmacy. However, after the New England Compounding crisis of 2012, the Drug Quality and Security Act was passed and granted the FDA authority to inspect facilities and enforce regulations.
Figuring out how state and federal compounding rules and regulations are going to work together remains to be seen as sterile compounding regulations vary in many states.
Stay tuned to the Baer Law Blog for more updates on sterile compounding.
State boards of pharmacy continue to have primary responsibility of the day-to-day oversight of state-licensed pharmacies that compound drugs in accordance with Section 503A of the Food and Drug Cosmetic Act (FDCA) while the FDA regulates and inspects registered outsourcing facilities licensed under Section 503B of the FDCA.
While the exact definition of compounding may vary slightly state by state, in general terms, compounding is a practice in which a licensed pharmacist, a licensed practitioner, or in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist combines two or more drugs to create a tailored medication to address the needs of an individual patient.
Currently, Section 503B only applies to human compounding and the veterinary medicine community continues to explore pharmacy related legislation changes that would specifically address the unique needs of their animal patients.
According to the American Veterinary Medical Association (AVMA), nine states have laws or regulations that permit licensed veterinarians to administer and dispense compounded products, in some cases under specified conditions. In the past few months, at least four more states have introduced bills or regulations that would permit or place limitations on compounding for animal patients in specified situations.
Maryland recently introduced SB 614 which provides an exception to state pharmacy law, specifying that it does not prohibit a licensed veterinarian from dispensing a sterile or non sterile compounded preparations, provided by certain pharmacies, for use in a companion animal, under specified circumstances. Additionally, under SB 614, a pharmacy would be authorized to provide certain compounded preparations without a patient-specific prescription to a certain licensed veterinarian under certain circumstances.
Massachusetts introduced HB 3989 which would authorize a veterinarian to dispense a compounded drug, distributed from a pharmacy, when the animal is his own patient within the valid veterinarian-client-patient relationship (VCPR), as defined by the Principles of Veterinary Medical Ethics of the AVMA provided that:
- The animal is a companion animal;
- The quantity dispensed is no more than a 120 hour supply;
- The compounded drug is for the treatment of an emergency condition; and
- Timely access to a compounding pharmacy is not available as determined by the prescribing veterinarian.
The Massachusetts bill would also allow a veterinarian to compound for individual patients within a valid VCPR provided that the veterinarian (1) does not compound from bulk substances, (2) does not duplicate proprietary products, (3) does not wholesale compounded medications and (4) does not compound from federally controlled substances for dispensing.
New York is considering a bill that would allow pharmacists to compound strictly limited amounts of substances for veterinary facilities which in turn could then dispense, under certain limited circumstances, to animals with which the veterinarians have a valid VCPR. Interestingly, the New York bill addressed the uniqueness of veterinary medicine:
- “Unlike human medicine, veterinary medicine has a unique service model. In many cases there is no ready alternative to a veterinarian having compounded medicines on had at all times. This is especially true in emergency situations and at night and on weekends and holidays where there is no practical alternative but the animal hospital and its staff veterinarians for the purposes of filling a prescription for an animal with which a veterinary client patient relationship exists. The alternative to the safe and proper use of these safe substances would in many cases be suffering and possible death for the animal in need of them.”
The New York bill provides additional safeguards by strictly limiting the quantities of compounded pharmaceuticals that a veterinary practice may have on hand to a short term supply of 100 doses or twelve ounces of liquid medications, twelve ophthalmic, topical or inhaled preparations and 100ml of sterile injectable solutions.
Last week in Colorado, HB 16-1324 was introduced to the House Health, Insurance, & Environment committee. HB 1324 would authorize:
- A compounding pharmacy to compound and distribute a drug to a veterinarian without a specific patient indicated to receive the compounded drug and
- Allow a veterinarian to dispense a compounded drug, maintained as part of the veterinarian’s office stock, in an amount not to exceed 5 days worth of doses, if a patient has an emergency condition that the compounded drug is necessary to treat and the veterinarian cannot access, in a timely manner, the compounded drug through a compounded pharmacy.
Patient safety remains paramount while states continue to address veterinary compounding, office use and office stock in an effort to protect the health, safety and welfare of the animal population.
Baer Law will continue to keep you updated on veterinary compounding issues.
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.
Earlier this year, the Louisiana Board of Pharmacy (Louisiana Board) exercised the emergency provision of the Louisiana Administrative Procedure Act (R.S. 49:9.53.B), to amend its rules governing the compounding of drugs by pharmacies and restored the capability for pharmacies to compound drugs intended for the administration by veterinarians without the necessity of a patient-specific prescription.
As previously discussed at length on the Baer Law Blog, after the passage of the Drug Quality and Security Act (DQSA) of 2013, many state boards of pharmacy amended their rules regarding to address compounded medications and adopted rules requiring patient-specific prescriptions. However, the Food and Drug Administration (FDA), in clarifying the DQSA, stated the DQSA only applies to compounding drugs for human use and does not apply to the compounding of drugs for animal use.
The Louisiana Board, after reviewing requests from veterinarians and many other concerned organizations regarding the dire need for emergency use veterinary compounded drugs, recently restored the authority for pharmacies to compound drugs for office use by veterinarians only, and not for human use.
Through its emergency rule, which the Louisiana Board cited its desire to prevent imminent peril to the public health, safety and welfare, the Louisiana Board granted the temporary authority for pharmacies to compound medications for office use by veterinarians. Per the Louisiana Board, the emergency declaration remains in effect until for the maximum time period allowed under the Administrative Procedure Act or until the adoption of the final rule, whichever occurs first.
The new temporary Louisiana Board rules can be found under §2535.
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.← Older posts