Compounding is the original way of making drugs. The advent of modern manufacturing and mass production relegated the old-fashioned art to the background. But compounding is undergoing a revival, driven in part by patients ’ greater willingness to itry alternatives for their health; in part by pharmacies’ interest in alternative markets; and in part by inconsistent and poorly enforced rules governing the industry.
When I was growing up in india almost every doctor's clinic had a compounder who was more like a medical assitant cum Pharmacist who used to prepare medicines according to the doctor's prescription .
the various chemicals and coloured liquids used to create a mysterious atmosphere to the clinic.
in some rural areas of india such compounders used to practice medicine on their own which was considered Quackery by the mainstream medical practitioners .but was driven mainly by demand and lack of supply of trained medical providers
Because compounding is considered distinct from pharmaceutical manufacturing, compounders operate outside the extensive, expensive testing and approval process overseen by the U.S. Food and Drug Administration (FDA). Compounded drugs are not FDA-approved. They are largely untested formally for safety and efficacy.
Frequently Asked Questions About Pharmaceutical Compounding
What is compounding, and why is it necessary?
Compounding is the creation of a pharmaceutical preparation—a drug—by a licensed pharmacist to meet the unique needs of an individual patient (either human or animal) when a commercially available drug does not meet those needs. A patient may not be able to tolerate the commercially available drug, the exact preparation needed may not be commercially available, or a patient may require a drug that is currently in shortage or discontinued. The U.S. Pharmacopeia Convention (USP) formally defines compounding as “the preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner's prescription, medication order, or initiative based on the practitioner/patient/ pharmacist/compounder relationship in the course of professional practice.”
Following are a few examples of how a compounding pharmacist can customize medications based upon a doctor’s prescription to meet a patient’s needs:
- Customize strength or dosage.
- Flavor a medication (to make it more palatable for a child or a pet).
- Reformulate the drug to exclude an unwanted, nonessential ingredient, such as lactose, gluten, or a dye to which a patient is allergic.
- Change the form of the medication for patients who, for example, have difficulty swallowing or experience stomach upset when taking oral medication.
Compounding pharmacists can put drugs into specially flavored liquids, topical creams, transdermal gels, suppositories, or other dosage forms suitable for patients’ unique needs. Compounding does not include making copies of commercially available drug products, as this is not allowed by law.
How is pharmaceutical compounding different from drug manufacturing?
Traditional compounding is the preparation of a medication to meet the prescriber’s exact specifications and to be dispensed directly to the patient, pursuant to a valid prescription for that patient. Pharmaceutical compounding is performed or supervised by a pharmacist licensed by a state board of pharmacy (see question below on legal oversight of compounding versus manufacturing). Manufacturing is the mass production of drug products that have been approved by the Food and Drug Administration (FDA). These products are sold to pharmacies, health care practitioners, or others who are authorized under state and federal law to resell them.
What is a compounding pharmacy?
While most pharmacies offer some level of compounding, most compounding is done in pharmacies that have made the investment in equipment and training to do so safely and efficiently. The preparations offered by these compounding pharmacies can be nonsterile (ointments, creams, liquids, or capsules that are used in areas of the body where absolute sterility is not necessary) or sterile (usually intended for the eye, or injection into body tissues or the blood).
All licensed pharmacists learn during their training and education to perform basic compounding. In addition, most pharmacies have some compounding tools, such as a mortar and pestle for grinding materials, graduated cylinders for measuring liquids, balances for weighing solids, spatulas for mixing materials, and ointment slabs on which to work. With such tools and through applying their knowledge, all pharmacists routinely prepare nonsterile compounded preparations when requested by prescribers.
Of the approximately 56,000 community-based pharmacies in the United States, about 7,500 pharmacies specialize in compounding services. This means the pharmacists in those facilities spend most or all of their time compounding special preparations for patients. Preparations made in these pharmacies are more likely to include both sterile and nonsterile dosage forms. Compounding also takes place in hospital pharmacies and at other health care facilities.
Who regulates compounding pharmacies? Do compounding pharmacies follow the same regulations as drug manufacturers? Why or why not?
The practice of compounding is regulated by state boards of pharmacy. Community and hospital compounding pharmacists are allowed exemptions to the Federal Food, Drug, and Cosmetic Act of 1938 if they comply with the regulations outlined in Section 503A. All pharmacists and pharmacies engaged in compounding are subject to oversight by both federal and state authorities.
Pharmacists engaged in compounding are expected to follow applicable standards and regulations for the types of preparations that are compounded. FDA has oversight for the integrity and safety of the drugs (called Active Pharmaceutical Ingredients, or APIs, by FDA) used in compounded preparations. The Drug Enforcement Administration (DEA) has oversight for any controlled substances used in the preparation of compounded medications. Controlled substances include narcotics such as hydrocodone, amphetamines, and similar drugs, and drugs such as those used for anxiety and sleep disorders.
In addition, the United States Pharmacopeial (USP) Convention issues standards that apply to compounding. This private, nonprofit organization defines the chemical purity of drugs and also issues practice standards. USP develops standards for the identity, quality, strength, and purity of medicines, dietary supplements, and food ingredients that may be used in compounding preparations. These standards in particular are relevant to compounding pharmacists.
USP General Chapter <797> is a national standard for the process, testing, and verification of any compounded sterile preparations. It provides guidance on preventing microbial contamination and other variances in compounded sterile preparations, regardless of setting (e.g., hospitals, community pharmacies) or who is performing the compounding (pharmacists, nurses, pharmacy technicians, or others).
USP General Chapter <795> provides similar guidance for nonsterile preparations that are compounded in health care settings. It describes categories of compounding (simple, moderate, complex), defines concepts such as beyond-use date and stability, and provides criteria for compounding pharmacists to follow in preparing various drug preparations.
USP General Chapter <800> is a new standard developed by USP that establishes practice and quality standards of hazardous drugs to minimize the exposure to hazardous drugs within health care settings. This standard aims to promote worker safety (pharmacists, pharmacy technicians, veterinarians, veterinary technicians, and many others), patient safety, and environmental protection. This standard was published on February 1, 2016, but will not be officially implemented until July 1, 2018. The current list of hazardous drugs is available from the National Institute for Occupational Safety and Health (NIOSH).
Compliance with these and other USP guidelines is considered the minimum standard of practice in pharmacy.
Pharmacy Compounding Accreditation
Pharmacy Compounding Accreditation is a service of the Accreditation Council for Health Care (ACHC) that assesses the nonsterile and sterile pharmacy compounding process as defined by a specific set of standards that concentrate on the quality and consistency of medications produced.
How would patients know if their medication is compounded? Knowing that, should they take any precautions, or do anything differently?
Ask. A patient can receive compounded drugs from a typical community pharmacy or a specialty compounding pharmacy, or compounded drugs can be administered by doctors or other health professionals in clinics or medical offices. Patients should ask the person administering a medication or the pharmacist dispensing a prescription whether it was prepared in a compounding pharmacy or manufactured by a drug company. A widely accepted standard of practice is to label all compounded preparations with information stating the medication has been “compounded.”
If a prescription calls for a compounded drug, patients can ask whether the compounding pharmacy is accredited. Lists of accredited compounding pharmacies are organized by state on the Pharmacy Compounding Accreditation Board’s (PCAB) website.
Does a compounding pharmacist have special training?
Compounding is a central activity to the practice of pharmacy. Pharmacists are taught in pharmacy school how to properly compound medications, and many states test pharmacists’ compounding knowledge and skills before issuing them a license.
Pharmacists who practice in the 7,500 pharmacies that specialize in compounding services have generally had advanced training in compounding after they graduated from pharmacy school. No state currently requires a particular type of training, and no nationally recognized specialty exists for pharmaceutical compounding. Specialized training in pharmacy compounding processes is available through several of the active pharmaceutical ingredient (API) suppliers serving the needs of the compounding pharmacy community.
When is a compounding pharmacy necessary?
A health care provider will prescribe a compounded drug only when commercially available drug products do not meet your needs. If you do not understand why you have been prescribed a special formulation, ask your prescriber. If you are concerned about taking a compounded drug and you and your prescriber agree that you can tolerate the commercially available drug, you may also ask if there is any evidence that your outcome will be better on the compounded formulation.
Where is more information about compounding available?
APhA has made available on this website the introductory chapter of a leading book it publishes on compounding pharmacy. Author Loyd V. Allen Jr., a recognized expert in pharmaceutical compounding and editor of the International Journal of Pharmaceutical Compounding, provides detailed information about many topics, including those presented in these FAQs.
For additional information about compounding pharmacy, contact IACP, PCAB, USP, the National Association of Boards of Pharmacy (NABP) or the appropriate state board of pharmacy.
If you are interested in information on new regulations, news stories, and practice standards in compounding pharmacy, these are available on APhA’s “Just the Facts” page. The FDA and CDC websites provide up-to-date information, lists of affected facilities and states, treatment guidelines, FAQ statements and other resources to assist health care providers and the public in addressing this issue.
What caused the meningitis outbreak, and how could it have been prevented?
In 2012, patients developed fungal meningitis after receiving injections into the spinal column of a product prepared by the New England Compounding Center (NECC), according to the Centers for Disease Control and Prevention (CDC) and FDA.
A number of things went wrong with these preparations. Because the compounded preparation was a suspension (with visible particles) rather than a solution (a dispersion of the drug at the molecule level), the liquid could not be filtered in a way that would have removed bacteria and fungi. Because the preparation was being injected directly into the spine, no preservative or other additives that might have prevented fungal growth could be added. The drug itself was a type of steroid, and these agents decrease the body’s response to microorganisms, and this might have prevented some patients from fighting off the fungi on their own. Finally, because NECC was distributing the preparation to many states in large quantities—something that compounding pharmacies are not permitted to do under state and federal laws—some of these preparations remained unused for a long time in some cases (allowing the fungi to grow), and a large number of patients were affected.
Inspections of NECC by FDA and the Massachusetts State Department of Health found unsanitary conditions at NECC facilities and violations of the USP<797> standard as well as local law.
The report also found that NECC was distributing large quantities of compounded preparations “apparently for general use rather than requiring a prescription for an individual patient.” State law requires a prescription for compounding and dispensing medication.
“Manufacturing and distributing sterile products in bulk was not allowed under the terms of its state pharmacy license,” the report said. “If NECC was appropriately licensed as a manufacturer with the FDA, the company would have been subject to additional levels of scrutiny.”
Congressional hearings on November 14–15, 2012, examined what went wrong in the NECC case, the role and responsibility of regulators, and what can be done to prevent another such outbreak in the future.
Will the outbreak lead to reconsideration of or changes in current policy/regulations?
The Compounding Quality Act of 2012 was a direct outcome of increased regulation over compounding. This landmark legislation is also called the Drug, Quality and Security Act (DQSA) of 2013. The first section, Title I, is concerned with compounding. Title II deals with Track and Trace rules.
The DQSA established for FDA clear authority over certain aspects of compounding. The Act also created a new entity, called Outsourcing Facilities. Section 503B of the FD&C Act was added by this bill to govern outsourcing facilities.
Requiring board certification of pharmacists and/or accreditation of compounding pharmacies to provide complex compounding services could also be a result of the fungal meningitis outbreak. The Board of Pharmaceutical Specialties is developing a specialty designation for sterile compounding.
this article is 10 years old but nothing seems to have changed
Confounding compounding
Legal fog surrounds growing source of veterinary drugs
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November 23, 2009
By Edie Lau
Series
As a bird specialist with expertise in other exotic pets such as rabbits and reptiles, Dr. Laura Wade faces a particular challenge when it comes to prescribing medicine:
Very few drugs are manufactured specifically for her kinds of patients.
Consequently, Wade relies 99 percent of the time upon compounding, a pharmaceutical practice in which drugs are manipulated in dosage, form and flavor to accommodate a specific patient’s individual needs.
“I couldn’t practice without it,” said Wade, whose clinic is located near Buffalo, N.Y.
Compounding is the original way of making drugs. The advent of modern manufacturing and mass production relegated the old-fashioned art to the background. But compounding is undergoing a revival, driven in part by pet owners’ greater willingness to invest in their animals’ health; in part by pharmacies’ interest in alternative markets; and in part by inconsistent and poorly enforced rules governing the industry.
Because compounding is considered distinct from pharmaceutical manufacturing, compounders operate outside the extensive, expensive testing and approval process overseen by the U.S. Food and Drug Administration (FDA). Compounded drugs are not FDA-approved. They are largely untested formally for safety and efficacy.
Observers say these facts are downplayed by an industry for which the blurry divide between compounding and manufacturing has become a business opportunity.
“Compounding has its place, no doubt about it,” said Dr. Brett Cordes, a DVM serving as veterinary medical director for animal health at The Apothecary Shop in Phoenix, Ariz., which deals in both commercially manufactured and compounded pharmaceuticals.
“Unfortunately in veterinary medicine,” Cordes went on, offering a personal opinion, “there’s been a lot of — how should I say? — shenanigans going on.”
The situation is dividing the compounding industry and sowing confusion among practitioners about the right and wrong ways to use compounded medications. Observers say veterinarians are by turns victims and instigators of the problem.
The most blatant offense is the use of compounding to create cheap replicas of existing FDA-approved drugs. Some veterinarians may confuse compounded knock-offs with legitimate generic versions of the drug. Others knowingly seek the less-expensive copies.
Gigi Davidson, director of clinical pharmacy services at North Carolina State College of Veterinary Medicine, has heard this directly from clinicians. During a recent talk to the Florida Association of Equine Practitioners, Davidson displayed a slide of pirated drugs. “Why would a veterinarian use a copy of a commercially available, approved, tested, proven product?” she asked the audience.
“Economics,” listeners told her.
“You want to increase your profit margin?” she pressed.
No, they replied emphatically. “They said it was clients driving the use,” Davidson recounted. The practitioners reported pressure from clients to come up with less-expensive avenues for treatment.
To Davidson’s mind, allowing clients to drive medical decisions based on money is a dangerous precedent. “If a client asked you to use a dull scalpel because it’s cheaper, would you do that?” she said. “Why are you outsourcing your medical judgment to clients?”
Another way in which compounding is abused in the veterinary community, observers say, is through resale of compounded medications to clients. Unlike in human medicine, reselling manufactured, commercially available medications to clients is a common and accepted practice in veterinary clinics. Clinic owners are understood to take a piece of the profit.
Compounded drugs are different. They are made on an as-needed basis for office use or by prescription for individual patients only. And because compounded medications have not been through the rigorous federal drug approval process, Cordes said it is essential for the pharmacist to have direct contact with the patient’s owner in case of an adverse event or recall.
“We as a pharmacy cannot knowingly supply a DVM for resale because we lose that quality control,” he said.
But stopping the practice is not necessarily a simple matter.
At Valley Drug and Compounding in California, a pharmacy devoted almost entirely to veterinary medications for small animals, co-owner Irving Reitzenstein, Pharm.D., said he tries to discourage resale by limiting the amount of medicine he dispenses at one time. California regulations allow a veterinarian to resell to a client a 72-hour supply — enough to tide over a patient until its owner can get the prescription filled. “When you’ve got an office asking for 200 capsules of something, they’re not asking for a 72-hour supply,” Reitzenstein said.
As a general rule, “We try to limit it to 100 solid dosage units or a pint of liquid,” he said, but the rule is not hard and fast. “(For) a 24-hour emergency facility, a pint of antibiotic liquid might be nothing,” he noted. “So it’s very difficult sometimes to know when you’re crossing that line.”
Many veterinarians feel the same way. Dr. Wade, the avian and exotics practitioner in western New York, said she used to keep a variety of compounded drugs on hand for the sake of efficiency and flexibility. Then, the clinic owner, Dr. Melinda Burgwardt, asked Wade what she knew about rules governing compounding. “I kind of knew there were some regulations, but I didn’t know specifics,” Wade said.
Both practitioners began a long journey — still ongoing — to figure out what was acceptable and what wasn’t. “At one point, (Burgwardt) asked me not to have any of this (medication) in-house,” Wade said. “I said, ‘I can’t work that way. How can I do this in a way that’s legal and still takes care of my patients?’ ”
Wade ended up whittling her office-use supply to small amounts of four or five medications she needs most frequently. Having to wait to obtain the drugs until after a specific patient presents with a special need is too confining, given the nature of her practice. “I just need it when I need it,” she said.
What Wade keeps on hand she believes she can justify medically to anyone who might inquire. “I oversee it pretty carefully,” she said. “I want to play by the rules, but there is no black and white for me; it’s all gray.”
Burgwardt, who’s been in practice 23 years, recalls learning nothing about compounding rules in veterinary school. At one time, when clinic staff ordered a compound for in-house use and the pharmacy asked for the patient’s name, Burgwardt said, “We didn’t think anything of it and gave (the name of) one of our personal pets. Then I started hearing on VIN that it was illegal.”
It was through many online discussions on the Veterinary Information Network (VIN) that Burgwardt began to develop an appreciation for the complicated realm compounding occupies. After spending countless hours pondering the subject, she is exasperated by the whole matter.
“I think the rules for the pharmacies are made to protect the drug companies, and the rules for the veterinarians — they got stuck in the middle,” she said.
Cordes, the veterinarian at The Apothecary Shop, sees it differently. “How do you verify quality?” he said. “If you’re willing to break the rules, how do you know that anything a pharmacy is doing is quality or not? We as veterinarians need to know that when we reach for a compound, we are equally as liable as the compounding pharmacy.”
Federal laws and rules challenged, challenging
The FDA is acutely aware of problems and confusion associated with compounding, according to former officials of and consultants to the agency. Since 1996, the agency has sent out scores of warning letters to pharmacies alleging illegal compounding for veterinary use. But to all appearances, the agency has not followed up with vigor.
“(The warnings) have been, as far as I can tell, essentially ignored,” said Dr. Mark Papich, a veterinarian and clinical pharmacologist at North Carolina State University College of Veterinary Medicine, noting that many of the pharmacies continue their questionable practices.
Hamstringing FDA enforcement are a welter of complicated court decisions and litigation involving various laws on drug manufacturing and compounding.
Helping to confuse matters is the fact that compounding for human use and for veterinary use are governed by different rules. And while some compounders serve only the veterinary community, many serve both, making the division all the more confounding.
Three laws pertain to the issue: The Food, Drug and Cosmetic Act (FDCA), dating to 1938 and revised time and again over the years; the Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994, an amendment to the FDCA; and the Food and Drug Administration Modernization Act (FDAMA) of 1997, another FDCA amendment. (See timeline, upper right)
In one recent court battle, the government was sued over a provision in FDAMA that prohibits pharmaceutical compounders from advertising specific products if they wish to quality for an exemption from the drug-approval process. The issue went all the way to the U.S. Supreme Court, which held that the provision was an unconstitutional restriction of free speech.
Nevertheless, the use of advertising in compounding remains a point of contention. Aggressive marketing confuses practitioners and corrupts the purpose of compounding, critics say.
“I think veterinarians sometimes have been misled by some compounding pharmacies because they advertise their products to make it look like they’re actually (approved) products,” said Dr. Katrina Mealey, who teaches small animal medicine and pharmacology at Washington State University.
Davidson at NC State said the role of compounding is to answer the needs of individual patients, not to stimulate demand. “If I as a pharmacist want to create a need for a compound, that is not acceptable,” she said.
Reitzenstein said some advertising is appropriate, and some not. “If you’re going to advertise, you’re going to advertise who you are, what you do and how you do it,” he said. “I don’t think it’s appropriate to promote one particular product.”
Marcy Kelly, vice president of marketing and sales at Wedgewood Village Pharmacy, one of the nation’s largest compounding pharmacies, passionately disagrees. The availability of preparations needs to be communicated, she said, to inform patients or practitioners who otherwise might not realize they have more options.
“When you are treating cats diagnosed with megacolon, a life-threatening condition, and Propulsid, the human health drug that you commonly prescribe, goes off the market, you are anxious to find an alternative,” Kelly said. “When you receive information from a pharmacy that they can prepare it for your patients, then that’s meaningful to you.”
Wade, the avian specialist in New York state, agreed that marketing can convey valuable information. “I can tell you from all the compounding pharmacies I’ve seen at different conferences, everybody promotes their flavors; everybody promotes their special thing,” she said. “It’s like, we wouldn’t know that, if they didn’t promote their different things. ... I think a lot of people don’t appreciate what a wonderful option (compounding) is for us.”
What’s it made of?
Another contentious aspect of veterinary compounding is the use of bulk active pharmaceutical ingredients, the raw materials from which finished medications are made. Under the FDCA, only manufacturers undergoing the federal drug-approval process are allowed access to bulk chemicals. Under AMDUCA, compounders are supposed to use finished, approved drugs as their starting material when compounding for animals.
Compounders say that is an impossible rule. “If you didn’t use bulk drugs, you couldn’t provide (the service),” said Kelly at Wedgewood. “Veterinary patients have needs that cannot be serviced without using bulk ingredients.”
Reitzenstein agreed that compounding from finished drugs is simply impractical in certain situations. For example, the feline thyroid medication methimazole, the medication he makes up most commonly, comes in an approved pill slightly larger than a baby aspirin, and weighs 100 to 200 mg. Of that, the active ingredient may constitute only 2.5 mg or 5 mg, he said: “It’s 95 percent binders and fillers.”
For cats that fight pills, Reitzenstein receives orders frequently for liquid or transdermal methimazole. He said it is too difficult to derive the active ingredient in appropriate amounts from such small pills. “The only way we can work with it is with bulk chemicals,” he said.
The objection to liberal use of bulk ingredients in compounding is that ingredient quality is not assured. “We don’t know what’s in there,” said Mealey of WSU. “We don’t know if it’s pure, if it has contaminants. It’s potentially very risky. The FDA doesn’t necessarily inspect those (ingredients). And we know what happened with melamine in dog food that had some inspection,” she added, referring to the international poisoning scandal in which unscrupulous suppliers in China added the industrial chemical melamine to a pet food ingredient to inflate its apparent protein content.
Bulk ingredients used in manufactured drugs undergoing the FDA approval process, by contrast, are subject to careful scrutiny, according to Dr. Rich Carnevale, a former FDA deputy director of new animal drug evaluation now serving as vice president for scientific regulatory and international affairs at the Animal Health Institute, which represents pharmaceutical manufacturers and other animal-health companies.
“As part of the approval of the finished product, they have approved the manufacturer of the bulk ingredient,” Carnevale said. “They will have ... (reviewed) how it was produced, from start to finish.”
Compounders counter that their bulk-ingredient suppliers are not without oversight. The International Academy of Compounding Pharmacies (IACP) states on its Web site: “Just like big pharmaceutical manufacturing companies, compounding pharmacies get their ingredients for medications from suppliers that are registered and inspected by the FDA. Foreign suppliers are FDA-registered facilities.”
What does it mean to be FDA-registered? Under federal rules, all facilities engaged in manufacturing, preparing, propagating, compounding or processing drugs — including bulk ingredients — are required to register with the agency each year. Laura Alvey, a spokeswoman for the FDA’s Center for Veterinary Medicine, said registered facilities are inspected at least once every two years. “It’s important to note,” she added, “that FDA registration does not mean that the product is legal or FDA approved.”
Reitzenstein said he obtains bulk ingredients solely from reputable sources — suppliers who can certify the authenticity and purity of their drugs. He believes the majority of compounding pharmacies do the same. However, he added that suppliers without proven track records constantly solicit for his business, an indication that the temptation to obtain drugs from shadowy outlets is ever-present for compounders.
“We know there’s tremendous concern about chemicals coming in from China,” he said. “I get e-mails at least once or twice a month from companies predominantly in China that say that they can supply us with chemicals.”
The FDA recognizes a limited need by compounders to use bulk drugs. Through FDAMA, the government makes exceptions for the use of bulk ingredients in compounded products for human patients. But the veterinary counterpart to that act, AMDUCA is silent on the question of bulk use. That’s no accident, said Davidson.
Leaving it ambiguous was a compromise to get the law passed, she said: “Codifying the use of bulk chemicals for compounding would have been very threatening to the pharmaceutical industry, so they threw every lobbying effort they had at keeping it out,” she said. “But the FDA knew there were a handful of products that could be compounded only through the use of bulk ingredients, so FDA, veterinarians and pharmacies said, ‘Do not prohibit it.’ ”
Promised guidelines don’t materialize
As AMDUCA was being developed, the FDA produced a “compliance policy guide,” or CPG, which laid out the circumstances under which its enforcement officers would look the other way when bulk ingredients were used in compounding.
The CPG said bulk ingredients could be used when the health of the animal was threatened and no alternatives existed, said Davidson, who served on a task force that put together the document in 1992. “Some folks started using that as a loophole,” she said. “It got badly out of control on the veterinary side.”
So the FDA issued a new CPG in 2003 that greatly narrowed the agency’s tolerance for the use of bulk ingredients. The guidelines make an exception for only nine drugs, all poison antidotes for livestock. “There’s not anything for companion animals at all,” Davidson said. “It’s a very short-sighted document.”
As a critic of the guidelines, Davidson is in good company. So many people objected to the new CPG that the FDA on Sept. 1, 2004, announced it would draft a new version, and make it available for public comment that fall.
But it never did. Five years later, agency spokeswoman Alvey won’t say why. In an e-mail response to questions, she replied only: “I think it’s fair to say that we don’t anticipate any revisions to the 2003 CPG in the near future.”
Reitzenstein said the ongoing lack of certainty and clarity creates chronic stress. “The CPG basically says ‘This is how we will probably decide how to define the law. And we may or may not enforce it, but this is what our intent probably is,’ " he said. “It’s difficult to function under an environment like that.”
Observers say the FDA is unwilling to act until legal questions surrounding the issue are resolved once and for all. The 1998 court fight over advertising prohibitions was followed in 2004 by a case in which pharmacies challenged the authority of the agency to oversee compounding at all, asserting that the regulation of pharmacy practices is the jurisdiction of states alone.
The pharmacies won the first round in 2006, but the decision was overturned on appeal in 2008 and sent back to the trial court. On Nov. 6, Judge Robert Junell in the U.S. District Court Western District of Texas issued a revised judgment stating that compounded drugs are not generally exempt from the law governing “new drugs” and “new animal drugs” — in effect, that the FDA does have authority over compounding.
The lawyer for the pharmacies, Terry Scarborough of Austin, Texas, told VIN News Service that the plaintiffs, for reasons he could not disclose, have opted not to appeal that fundamental question to the U.S. Supreme Court. However, they may challenge other aspects of the revised decision.
“That new decision is like any decision — either side can appeal, and you can start the process all over again,” Scarborough said.
He said the plaintiffs may dispute parts of the order relating to FDA inspections of compounding pharmacies. The parties, he said, have until early January to decide their next move.
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