- 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 include ointments, creams, liquids, or capsules.
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.
- 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 patientPharmaceutical 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 does the FDA have to say about compounding?
Compounding is legal when a physician prescribes a customized medication to meet a specific need, and as long as that medication is demonstratively different from a patented manufactured drug.
- 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.
The USP <797> standard 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 products regardless of setting (for example, hospitals, community pharmacies) and who is performing the compounding (pharmacists, nurses, pharmacy technicians, or others).
USP <795> provides similar guidance for nonsterile preparations that are compounded in health care settings. It describes categories of compounding (simple, moderate, complex); defines terms such as beyond-use date and stability; and provides criteria for compounding pharmacists to follow in preparing various drug preparations.
Compliance with these and other USP standards is considered a standard of practice for pharmacies. Compliance carries the force of law in many states based on statutes or regulations passed by legislatures and boards of pharmacy.
- How would patients know if their medication is compounded? Knowing that, should they take any precautions – do anything differently?
Ask. A patient can receive compounded drugs from a typical community pharmacy or a specialty compounding pharmacy. Patients can their physician administering a medication or the pharmacist dispensing a prescription whether it was prepared in a compounding pharmacy or manufactured by a drug company.
- Does a compounding pharmacist have special training?
Compounding is a central activity in pharmaceuticals. Pharmacists are taught in pharmacy school how to properly compound medications, and many states test their compounding knowledge and skills before issuing licenses.
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.
- Where is more information about compounding available?
- How Compounds Work – Lipoderm As Example
The key in transdermal delivery of drugs is finding a vehicle that is able to solubilize drugs, and still possess the capacity to allow transdermal delivery. The advantage of Lipoderm is its constituents combine several entities, which allow for maximal solubilization of drugs, and maximal delivery of the drug through the skin. Lipoderm allows for disorganization of the skins structure, while leaving the skin intact and unharmed. Another advantage is Lipoderm’s absorption rate through the skin that it is slower while tissue levels remain higher for longer periods. The skin acts as drug reservoir, which allows for a slow release of drug from the subcutaneous tissue and allows for a longer duration of action oppose to oral administration. The combination of the ingredients in the compound cream can attack the cause of pain at the site of injury, and/or block pain perception at the spinal cord level.
- What are the possible side effects of using compounded medications?
Side effects vary per medication and patient. However, significant studies have shown that side effects are generally non-existent, even with repeated use due to the fact that the compound creams are not significantly absorbed into the bloodstream. The most commonly reported side effects are rash, irritation, or photosensitivity at the application site. If side effects do occur, try using less product, or applying it less frequently. Patients usually find they can lower their dose of other pain medication once a compounded medication starts working.