Subject:  Long but critical message

Fellow compounders,

It is happening AGAIN! In 1997, Clinton attempted to sneak in anti-compounding legislation inside the FDA Modernization ACT of 1997, when seven compounders immediately put a stop to it (ApothéCure was one of them). Now, Kennedy, along with Pat Roberts (KS) and Richard Burr (NC) are attempting to enact legislation, a SAFE COMPOUNDING BILL, which will prohibit physicians from treating their patients with useful and even life-saving compounds. Bio-Identical Hormone treatments and autism treatments are just a few compounds that will be severely threatened by this amendment.

It is still critical to contact your Senators and Representatives with phone calls and emails letting them know you have the right to have access to essential medications that only compounding pharmacies can provide. If you have already contacted them, please follow up to let them know you are monitoring this issue.

Please research for yourselves where these proponents get most of their funds from at the following web address:

• http://www.opensecrets.org/politicians/index.asp.

COMMENTS
KENNEDY DISCUSSION DRAFT – COMPOUNDING PHARMACY RESTRICTIONS

Conclusion:  There is no way to fix this proposed legislation; can only prevent its introduction, failing that, defeat the bill.

Reason:  Every provision beginning with definitions is carefully crafted to limit, undermine and discourage if not prevent compounding unique products.

• Would set aside office use regulations of Texas State Board of Pharmacy.
• Provides for exemptions and immediately defines drugs not complying with exemptions.
• Rigidly requires established relationship between compounding pharmacist and patient or prescribing physician.
• Prohibits compounding of approved drugs unless not available and then only in limited supply until available, taking advantage of compounding capability under uneconomic circumstances for pharmacy.
• Provides for a list of bulk drug and inactive ingredients promulgated by FDA- caution!
• Also standards for sterile compounding by FDA.
• Labeling requirements designed to equate to scare tactics; not applicable to facilities approved by FDA.
• Same with advertising disclosures – designed to discourage use of compounding pharmacy services.
• Specific products that shall not be compounded: i.e., copy of a drug approved by FDA (does not address approved drugs no longer commercially available).
• Provides for FDA to publish lists of drugs which cannot be compounded.
• Requires onerous extensive semi-annual reports (twice a year designed to discourage compounding because of red tape, especially for casual, occasional compounding by retailers for convenience of patients.
• Discourages, tends to limit distribution in interstate commerce. This is restraint of trade, an authority beyond the scope of FDA.
• Specifically authorizes FDA to promulgate regulations to enforce all these provisions. This is open season hunting license for FDA – THE MOST DANGEROUS PROVISION OF THIS DRAFT. This authority is inferred for ALL provision, but is blatantly, specifically authorized and threatened.
• Sets up collaboration of FDA with State Boards, sharing the required semi-annual reports working with State Boards to limit interstate commerce, and encourage investigations.
• Adding a layer of regulation on pharmacy and medicine over the traditional state authority for professional practices.

LIMITING COMPOUNDING, COMPOUNDING RESTRICTIONS paragraphs deep in the 24 page draft signals the intent of the proposed legislation (page 19).

FINALLY, the draft proposes authorization of appropriations in such sums as necessary from 2008-2012. This may overcome any limitations at the present for FDA to carry out whatever witch hunts it can conceive.

Economic impact on compounding pharmacy in terms of time and cost of compliance can not be calculated on account of the open authority of FDA to promulgate rules endlessly, especially when added to cost of compliance with new TSBP Compounding Rules.

For government, it could result in diminution of compounding pharmacy’s role, largely funded by private pay, transferring more Rx’s to traditional pharmacy, utilizing commercial sources adding to the burden of government in entitlement programs.

Gary Osborn, RPh, CCN
info@apothecure.com
1-800-969-6601
 
ApothéCure, Inc.
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ApothéCure Online Store
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Texas Institute of Functional Medicines
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SpectraPharm
Lobo Tejas Laboratories
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