Compounded Drugs
Compounded Preparations Disclosure Between Parties

 By Ronald M. McGuff, President McGuff Compounding Pharmacy Services Incorporated

One of the primary goals of McGuff Compounding Pharmacy Services is to disseminate relevant information to professionals who provide health care to patients.  It is important to us that you are informed about the regulatory environment that relates to prescribed compounded preparations. 

Recently, there have been many changes and challenges to National and State regulations that govern compounding pharmacies, physicians and patients who use compounded preparations.

Regulatory and legal issues surrounding compounded preparations suggest “full disclosure” be made between all parties in the patient-physician-pharmacist triad.

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 preparations (the term preparation is used to further differentiate compounded drugs from commercially available drugs). 

• Commercially available drugs (e.g. Premarin, Lasix, Inderal) are:

  • manufactured by U.S. Food and Drug Administration (FDA) inspected firms that are compliant with Current Good Manufacturing Practices enforced by the FDA.

  • available by prescription and are usually obtained at retail pharmacies such as Wal-Mart, Rite Aid, and CVS.

  • reviewed and approved 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 preparations are:

  • prepared by pharmacies that operate under state law, United States Pharmacopeia (USP) requirements and USP Good Compounding Guidelines.

• available by prescription from licensed pharmacies that are equipped to compound drugs such as McGuff Compounding Pharmacy Services, Inc.

• 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.

 We wish to emphasize that the FDA has not reviewed compounded preparations for safety and efficacy via the New Drug Application process.

Health care professionals should also take appropriate steps to educate their patients when a compounded preparation is prescribed. 

• Inform the patient that a physician has the right to prescribe compounded preparations based upon his/her knowledge of the patient’s health and his/her professional knowledge of the preparation prescribed.

Additionally, the patient should be advised that the compounded preparation:

• 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 or thoughts about our disclosure policy.  You may call us at 877 444-1133 or email us at answers@mcguff.com