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COMPOUNDING in the UNITED STATES
Eugene Lutz, Pharmacist, FAPhA [email protected]
FIP Community Pharmacy Section EXCO Member
In order to understand the state of compounding in the United States (USA) let me
first provide a brief history of compounding in the USA. During the decades of
1950 and 1960 there was a dramatic shift in the way pharmacy was practiced in
the USA due to the explosion of manufactured pharmaceutical products. Prior to
1950 nearly every pharmacy performed regular compounding as part of everyday
practice, but by the 1970’s very little compounding remained and what did remain
was usually pretty simple combinations of topicals or liquids. Even today the
majority of pharmacies in the USA do very little compounding. About 20 years
ago compounding began to be revived and pharmacists began to specialize in
compounding. Today about 10% (or about 6000) of the community pharmacies in
the USA perform a significant amount of compounding. The pharmacies that
perform most compounding today are primarily independent pharmacy owners
who see compounding as a niche that differentiates them in the pharmacy
marketplace and meets patient needs for customized medication. Most
compounding pharmacist’s think of compounding as a natural extension of
“Pharmaceutical Care” or “Medication Therapy Management”, since it is helping
solve medication related problems for the patient.
Manufactured pharmaceuticals are regulated by the Federal government (Food &
Drug Administration FDA). Since compounding is a part of pharmacy practice it is
regulated by the state Boards of Pharmacy. The FDA has, at times, attempted to
get into regulating compounding, but the concept of state regulation of
compounding has always been upheld in state & federal courts. If, however, a
pharmacy is doing large scale compounding the FDA may determine that this kind
of compounding is really manufacturing. The method used to determine if a
compounding pharmacy is compounding and not manufacturing is known as the
“compounding triad”. If the pharmacist compounds pursuant to a valid order of a
prescriber for a specific patient and only makes enough for reasonable future
expected prescriptions AND does not make and sell compounds to other
pharmacies or physicians for resale the pharmacist is compounding and is NOT
manufacturing.
Pharmacists in the USA who offer compounding services are able to customize
medications to the patient’s needs and make it possible for the pharmacist to
provide the entire range of medication needs of the patient. There are a lot of
reasons that explain why compounding is becoming increasingly popular:
1. Because of patent laws in the USA, there are many natural or already existing
medicinal ingredients that often cannot be patented and for that reason,
manufacturers don’t wish to spend the money to develop a commercial product.
2. There also are products that manufacturers have stopped making, because
they simply did not sell well enough to justify the cost of producing them. These
products may still have value for certain patients and can in many cases be
compounded by an experienced compounding pharmacist. 3. Another reason for
compounding is to put the medication into a commercially unavailable dosage
form that is better tolerated and can be administered successfully for the patient.
For example, there are many pharmaceuticals that are not available in liquid form
or topical form. In some of these cases it is possible to extemporaneously prepare
a compound to address this issue. 4. Certain patients may have allergic
reactions to excipients, dyes or vehicles used in manufactured medications.
Compounding is often necessary to make a product without these allergens so
that the patient can be successfully treated. 5. Some medications that are usually
given orally may have lower side effects and may be able to be dosed at lower
strength when administered topically. Good examples of this are many of the
hormones needed to treat hormone deficiency- for example, estrogens,
progesterone, testosterone, etc. 6. Another major area is veterinary
compounding. Some of the commercial products that once were available for
animals have been discontinued for economic reasons, but can still be useful
treatments when properly compounded. 7. In my practice we compound many
medications into dosage forms that will be tolerated by pets, especially cats. 8.
Sterile compounding is also growing in the USA with the need to prepare
injectables in high dosage forms for implanted pumps that are unavailable
commercially as well as preparation of total enteral nutrition products. 9. Eye
drops and inhalant solutions are also being compounded to meet certain specialty
treatment needs.
Pharmacists have been assisted in the development of modern compounding
activities by suppliers of bulk chemicals, packaging materials and compounding
equipment. Compounding pharmacies typically build separate compounding
laboratories for sterile and non sterile compounding and adhere to voluntary
standards from such organizations as the United States Pharmacopeia (USP) and
the Pharmacy Compounding Accreditation Board (a voluntary accrediting
organization). The International Academy of Compounding Pharmacists (IACP),
compounding suppliers and others are active in collecting and disseminating
proven formulas and compounding guidelines. Because compounding is
becoming increasingly complex and sophisticated, state pharmacy boards are
writing updated regulations to govern compounding activities. Most state
pharmacy boards require compounding pharmacists to have specific policies and
procedures in place, specialized compounding training for pharmacists and
technicians and regular certification of specialized compounding equipment.
Compounding can be a very rewarding pharmacy specialty by providing better
care to the patient and better reimbursement for the pharmacist’s services. It is a
very personal way to make a large impact on the health of your patient. There is
great satisfaction in providing compounding services that so often have
dramatically successful positive affects for your patients. If you would like more
information I have listed several web sights that may be helpful. You also can
contact me at [email protected] if you have any questions.
Eugene M. Lutz, R.Ph.,FAPhA
Web sights for more information:
International Academy of Compounding Pharmacists (IACP)
www.iacprx.org
Professional Compounding Centers of America (PCCA)
www.pccarx.com
International Journal of Compounding
www.compoundingtoday.com
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