How Save IVF Complies with the FDA

 

Save IVF understands that ordering IVF medication can cause one to be hesitant. Especially when numerous rumors are going around how ordering medications from overseas can be unsafe. Well, we are here to put those rumors to rest and assure you that ordering IVF medication with Save IVF is the safest and best option for you.

Save IVF is aware of the significant cost difference between IVF drugs available here in the United States and those in other countries. IVF medication can cost several thousands of dollars if purchased in the U.S. This results in financial hardships for patients and their families. Save IVF has partnerships with various IVF clinics and pharmaceutical-manufacturing firms to save patients a considerable amount of money for prescription products sourced outside the U.S.

The below facts summarize Save IVF policies that comply with the U.S. Food & Drug Administration’s (FDA) policies regarding personal importation of the prescription drug products that are manufactured by firms outside the U.S. and in compliance with good manufacturing practice regulatory requirements.

The FDA states in its regulations that patients are allowed to purchase prescription medication from international pharmacies as long as it's for personal use. To proceed with receiving their medication patients must affirm in writing that the medications being imported are for their private use or provide a copy of their prescription written by their U.S.-licensed medical provider who's responsible for their treatment.

FDA has a policy explaining that it typically does not object to personal imports of drugs that the FDA has not approved under certain circumstances, including the following situation(s):

  • The drug is for use for a serious condition for which effective treatment is not available in the United States;
  • There is no commercialization or promotion of the drug to U.S. residents;
  • The individual importing the drug verifies in writing that it is for his or her own use, and provides contact information for the doctor providing treatment or shows the product is for the continuation of treatment begun in a foreign country.
  • Generally, no more than a 3-month supply of the drug is imported.
  • The FDA does not object to personal imports of drugs as long as it is not considered to represent an unreasonable risk to the patient.
  • FDA guidance states that international pharmacy ordering is done at the patient’s own risk.

The FDA does not allow importation from COMPOUNDING pharmacies even if the drugs are of equivalent quality to the U.S.-manufactured drugs. With that being said, Save IVF guarantees that the medications provided to patients are not compounded and are manufactured in either FDA-approved manufacturing facilities outside of the United States or in facilities that have been inspected and approved by European regulatory agencies equivalent to the FDA such as the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA).

FDA-compliant pharmaceutical manufacturing firms include IBSA Pharmaceuticals Italy, Kocak Farma Turkey, Merck Serono Ltd United Kingdom, Sandoz International GmbH Germany, Ferring International Center S.A. Switzerland, and Pfizer Denmark.

Did you know that IVF clinics are not permitted to import prescription drugs for commercial distribution or resale for profit? Instead, IVF clinics are permitted to receive and properly store prescription medications on the patient’s behalf. IVF clinics can send individual patient prescriptions directly via fax or email to any legitimate international pharmacy of the patient’s choice. Clinics can provide a drug price comparison list to their patients to help save money.

It is important to note that IVF clinics are not liable for any issues that surface when ordering through an international pharmacy. It is for this reason that numerous clinics have partnered with Save IVF. Save IVF is reputable and has access to a legitimate international pharmacy to which IVF clinics feel comfortable recommending. Save IVF delivers on time, is available 24/7 via email, and provides medication that works and is safe for the patient. Save IVF educates clinics so that they are more knowledgeable when patients ask for advice about using international pharmacies. Clinics should advise against pharmacy websites that ship out medications to patients without a valid prescription or physician visit. These online pharmacies are more prone to providing depraved or sub-potent medications that were manufactured in an unregulated facility, therefore putting the patients' health at risk. 



Older Post Newer Post