Frequently Asked Questions About Pharmaceutical Compounding
Last Updated: November 19, 2012
What is pharmaceutical 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 when commercially available drugs do not meet those needs. A patient may not be able to take the commercially available drug, or a patient may require a drug that is currently in shortage or discontinued.
These are a few examples of the ways a compounding pharmacist can customize medications with a doctor’s prescription to meet a patient’s needs:
- Adjust strength or dosage.
- Flavor a medication, for example to make it more palatable for a child.
- Reformulate the drug to exclude an unwanted, nonessential ingredient, such as gluten or a dye that a patient is allergic to.
- 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, suppositories, or other dosage forms suitable for patients’ unique needs. Compounding does not replicate commercially available drug products.
How is pharmaceutical compounding different from drug manufacturing?
Compounding is the preparation of an individual drug to meet the prescriber’s exact specifications and to be dispensed directly to the patient or the prescriber. Pharmaceutical compounding is performed or supervised by a pharmacist licensed by a state board of pharmacy (see below question on legal oversight of compounding versus manufacturing). Compounded drugs are not for resale by the patient or prescriber.
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 authorized under state and federal law to resell them.
What is a compounding pharmacy?
While all pharmacies do some types of compounding, this is more common or the primary focus of a small portion of American pharmacies. 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 injection into body tissues or the blood).
All licensed pharmacists learn during their four years of pharmacy school to perform basic compounding. In addition, all pharmacies have compounding tools such as a mortar and pestle for grinding materials, graduated cylinders for measuring liquids, scales for weighing solids, spatulas for mixing materials, and pill tiles on which to work. With such tools and applying their knowledge, all pharmacists routinely prepare nonsterile compounded products when requested by physicians.
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 in these pharmacies are more likely to be both sterile and nonsterile. 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?
All pharmacists and pharmacies involved in compounding are subject to oversight by both federal and state authorities.
The practice of compounding is regulated by state boards of pharmacy. Pharmacists engaged in compounding are expected to follow appropriate procedures for the types of preparations that are compounded.
FDA has oversight for the integrity 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 quasigovernmental organization defines the chemical composition of drugs and also issues practice standards. Two standards in particular are relevant to compounding pharmacists.
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