Compounded Preparations versus Commercial Prescriptions

Commercially available medications are mass produced by Food and Drug Administration (FDA) licensed facilities following Good Manufacturing Practices.

Compounded preparations are prepared for a specific patient based upon a specific order from that patient’s prescriber.  Compounding pharmacies are licensed and regulated in the 50 states and the District of Columbia by their respective state board of pharmacy, and are subject to the guidelines issued by an independent standards setting organization, the United States Pharmacopeia (USP).

Commercially available medication is approved by the FDA for one or more indication(s) and manufacturers issue FDA approved package inserts that detail dosing, frequency, warnings, contraindications, interactions, adverse reactions, and monitoring information.  Commercially available medication is dispensed by retail and mail order pharmacies.

Compounded preparations are, by definition, not FDA approved.  However, the FDA “recognizes that pharmacists traditionally have extemporaneously compounded and manipulated reasonable quantities of human drugs upon receipt of a valid prescription for an individually identified patient from a licensed practitioner.”  As per the FDA’s Compounding Compliance Policy Guide, compounds are exempted from the FDA approval process providing the pharmacy operates in accordance with state law and dispenses preparations "upon prescriptions of practitioners licensed to administer such drugs to patients under the care of such practitioners in the course of their professional practice, and which do not manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs or devices at retail.”

Compounded preparations are dispensed by pharmacists that are properly trained and from pharmacies with specialized equipment.  In addition to many hours of continuing education, our compounding pharmacists regularly attend industry meetings and seminars dedicated to enhancing our compounding practice.

The basis of the profession of pharmacy has always been the "triad," the patient-prescriber-pharmacist relationship. Through this relationship, patient needs are determined by a prescriber, who chooses a treatment regimen that may include a compounded medication.  Prescribers often prescribe compounded medications for reasons that include (but are not limited to) the following situations:

1. When needed medications are discontinued by or generally unavailable from pharmaceutical companies, often because the medications are no longer profitable to manufacture;
2. When the patient is allergic to certain preservatives, dyes or binders in available off-the-shelf medications;
3. When treatment requires tailored dosage strengths for patients with unique needs (for example, an infant);
4. When a pharmacist can combine several medications the patient is taking to increase compliance;
5. When the patient cannot ingest the medication in its commercially available form and a pharmacist can prepare the medication in cream, liquid or other form that the patient can easily take; and
6. When medications require flavor additives to make them more palatable for some patients, most often children.

Pharmacists do not compound without the approval of an individual patient’s prescriber and prescribers should also take appropriate steps to educate their patients as to the reasons why a compounded preparation has been prescribed.

Condo Pharmacy will not compound under the following circumstances:

1. Medications that were withdrawn or removed from the market for safety reasons;
2. For third parties who resell to individual patients;
3. Medications that are commercially available in the marketplace or that are essentially copies of commercially available products, except in limited circumstances based upon an individual patient’s unique medical need.

Compounding has been a part of the profession of pharmacy since its inception.  As the field of pharmacogenomics continues to expand, more and more medications will be tailored to meet the individual needs of the patient taking that medication.  Pharmacists and, properly equipped compounding pharmacies, are unique in their ability to meet these needs.

If you have any questions about compounding please do not hesitate to call the pharmacy and ask for one of our compounding pharmacists.

Links:

The International Academy of Compounding Pharmacists: http://www.iacprx.org/site/PageServer?pagename=home_page

Compounding Facts: http://www.compoundingfacts.org/

FDA Homepage: http://www.fda.gov/

FDA Compounding Compliance Policy Guide: http://www.fda.gov/ora/compliance_ref/cpg/cpgdrg/cpg460-200.html

Patients and Professionals for Customized Care (P2C2): http://www.iacprx.org/site/PageServer?pagename=P2C2

USP Homepage: http://www.usp.org/