As part of our disclosure we want to reinforce that there are two basic categories of drugs that can be
ordered via prescription; commercially available drugs and compounded medications.
Commercially available drugs are:
- Manufactured by U.S. Food and Drug Administration (FDA) inspected companies that are deemed to
be
compliant with FDA Current Good Manufacturing Practices.
- Typically obtained by patients via prescription at traditional retail pharmacies such as
Wal-Mart,
CVS, Walgreens etc.
- Reviewed by the FDA for safety and efficacy.
- Approved by the FDA for one or more specific indications and contain package inserts that may
explain usage, contraindications, warnings, precautions, adverse reactions and drug
incompatibilities.
Compounded medications are:
- Prepared by pharmacies that operate under state law, United States Pharmacopeia (USP)
requirements
and USP Good Compounding Guidelines.
- Typically obtained by patients from licensed pharmacies that are equipped to compound drugs
- Provided based on the medical need of an individual patient
- Not reviewed by the FDA or State Boards of Pharmacy for safety and efficacy.
- Not approved by the FDA for any indication and do not contain FDA reviewed package inserts that
may
explain usage, contraindications, warnings, precautions, adverse reactions and drug
incompatibilities.
Health care professionals should also take appropriate steps to educate their patients when a compounded
medication is prescribed.
- The physician should inform the patient that a physician has the right to prescribe compounded
medications based upon his/her knowledge of the patient’s health and his/her professional
knowledge
of the medication prescribed.
Additionally, the patient should be advised that the compounded medication:
- Is provided based upon the medical need of the individual patient.
- Is prepared by a licensed pharmacy.
- Has not undergone the FDA’s New Drug Application process and has not been reviewed or approved
by
the FDA for safety or efficacy.
Please let us know if you have any questions about our disclosure policy. You may call us at
800-542-5767 or
email us at info@rxcompound.com