Government Regulations are Changing the Way We Can Help You
Here are a some examples of how there have been major changes to the laws regulating compounding pharmacy...
- 1997 FDA Modernization Act 1997 Section 503a Compounding Pharmacy (implemented in 1998)
- October 2001 California Business and Professions Code Section 4127-4127.6
- April 29, 2002 U.S. Supreme Court Overturns FDA Modernization Act Section 503a Compounding Pharmacy
and some examples of current guidelines under revision...
- United States Pharmacopeia XXIV Chapter 797 Pharmaceutical Compounding, Sterile Preparations. (copyrighted material)
- Compliance Policy Guide, Compliance Policy Guidance for FDA Staff and Industry, Chapter - 4, Sub Chapter - 460
How does this affect you?
The legal environment in which McGuff Compounding Pharmacy and other compounding pharmacies operate ultimately determines how we collectively, are able to respond to your needs.
New laws, such as the California Business and Professions Code listed above, are designed to improve the quality of our products.
Laws such as the 1997 FDA Modernization Act had substantial flaws (restriction of freedom of speech) and has been struck down by the courts.
We anticipate that the laws governing the compounding of medications will become more and more restrictive. It is our hope and desire that the individualized medications prescribed by your physician will be available when you need them.
It is extremely important to you, our customer, our friend, that you have a compounding pharmacy that will work with numerous government entities to ensure that someone speaks on your behalf.
We believe there is a fair and equitable way to regulate the compounding of medications without adversely affecting public health or the New Drug Approval process (necessary to assure the public has access to large quantities of standard medications).
The McGuff Compounding Pharmacy is currently working in the following areas to promote, assist, debate, and provide technical input so that a reasonable and lawful solution is found that will allow the continued flow of quality, individualized medications to the patients that need them.
Our current efforts in your support are:
California State Board of Pharmacy:
Our Director of Pharmacy
Services
and Director of Quality Systems are providing technical assistance for the
adoption of Guidelines for Sterile Compounding of Injections as required in
Business and Professions Code 4127.
United States Pharmacopeia (USP):
Our Senior Management
team is reviewing the proposed mandatory section of the USP, Chapter 797
Pharmaceutical Compounding, Sterile Preparations.
Our response will be reviewed by the USP Convention.
Regulatory Environment:
As a member of the
International Academy of Compounding Pharmacists we are sending our
Director of Pharmacy Services to Washington DC to attend seminars and meet with
members of the House and Senate. There is currently no Federal Law
that regulates compounding pharmacy. It is imperative that the
legislature be aware of the needs of patients and to clarify any misperceptions
our legislators may have about compounding.
We at the McGuff Compounding Pharmacy strive to reinvent our mission statement every day!
Our Mission
Statement
To Retain Our Uncompromising
Passion for
Quality Pharmaceuticals and Customer Satisfaction
