WE NEED YOUR HELP NOW to Protect your Access to Compounded Medications.

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Our Compounding Pharmacy Can Help Every Member of Your Family!

Our compounding pharmacists work directly with practitioners including physicians, nurse practitioners, dentists and veterinarians to create customized medication solutions for patients and animals whose healthcare needs cannot be met by manufactured medications.

Compounding helps people and pets in our community with problems such as:

  • chronic pain related to injuries or illness such as cancer, or neuropathic pain (associated with diabetes, or following chemotherapy or shingles).
  • Autism Spectrum Disorder.
  • hormone imbalances.
  • infertility.
  • dermatologic problems including rosacea, psoriasis and pigmentation disorders.
  • slow-healing wounds.
  • oral problems including chronic canker sores (aphthous ulcers) or cold sores.

We can compound medications that are:

  • unavailable due to current drug shortages or lack of manufacturer profitability.
  • free of additives such as dyes, gluten, alcohol, lactose and sugar that are present in manufactured medications. 
  • vegan-friendly.
  • in dosage forms such as topical or transdermal gels that are not commercially available.
  • suitable for cats, dogs and other animals with Infections, skin disorders, chronic pain, or thyroid disease.

S.959 would unduly restrict access to custom compounded medications, The bill is a reaction to the tragedy of the New England Compounding Center (NECC) that produced contaminated injectable medications and shipped thousands of doses around the country, resulting in patient deaths from fungal meningitis. In its current form, S.959 would give the Federal Food and Drug Administration (FDA) broad new authorities with little to no additional accountability to prevent a repeat of the mistakes and ineffectiveness of state and federal regulatory authorities that resulted in a failure to inspect and shut down NECC.

Other concerns:

  • S.959 is well intentioned but unworkable in the health care setting, does nothing to solve the problem and can actually be harmful as it will prevent access to needed medications. 
  • The exemptions for health systems from the new regulations that are created by the bill mean that patients who receive compounded medications via mail order from a PBM (Pharmacy Benefits Manager) – a frequent occurrence – are not guaranteed to be of the same safety standards as those who receive compounded medications from a pharmacy.
  • S.959 provides for broad expansion of the FDA’s ability to add medications to a “do not compound” list, if in their opinion it is deemed unsafe, ineffective, or demonstrably difficult to compound. We are concerned about this because the person making the decision will not be required to have any substantial knowledge of pharmacy or advanced training in compounding, and “demonstrably difficult” is subject to interpretation. Those who have not received specialized training in compounding may find preparations to be “demonstrably difficult” to compound, while professional compounders with the proper equipment would easily be able to properly compound the medication. This can place serious limitations on a practitioner’s ability to prescribe what is best for each patient. 
  • The enforcement of S.959 is not addressed. However, it does provide for civil and criminal penalties at the federal level for pharmacists who are out of compliance, which could be as simple as an error in record-keeping even if no patient harm results. Certainly, this is unduly harsh punishment which can be enforced preferentially. 
  • S.959 may conflict with existing state law and states’ rights. 

Safety is of the utmost importance and we support actions to improve safety and protect patients everywhere. However, S.959 has unintended consequences that will deny patient access to important medications prepared by reputable professional compounding pharmacies. You may not be using compounded medications now but S.959 will limit your future options and your physician’s/dentist’s/veterinarian’s ability to prescribe the best solution for you, your family or your pet.

Please contact your Senators and Representatives TODAY and SPEAK OUT TO OPPOSE BILL S.959.

You can find your Senators’ contact info at http://www.senate.gov/general/contact_information/senators_cfm.cfm and www.help.senate.gov/about/contact lists the members of the Senate HELP Committee that introduced S.959. We believe that the most effective method of contact is via a personal phone call to voice your concerns to a staff member.

If S.959 passes the Senate, it will go to the House of Representatives for consideration, and further action will be required before the bill becomes law. Other legislation is being worked on concurrently by Congressman Griffith. You can find updates and more information at www.iacprx.org and www.ProtectMyCompounds.com.

 

ACT NOW TO PROTECT YOUR ACCESS TO CUSTOMIZED MEDICATIONS
and as always, bring us your medication problems!

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