The preparation of a drug to address the prescriber’s precise specifications and to be dispensed directed to the patient pursuant to a valid prescription for that patient, is known as traditional pharmaceutical compounding.
Pharmaceutical compounding is done or supervised by a pharmacist who is licensed by a state board of pharmacy.
Drug manufacturing refers to the mass production of drug products that have received Food and Drug Administration (FDA) approval. These products are sold to pharmacies, medical care practitioners, or others who are authorized under federal and state law to resell them.
American Integrative Pharmacy (AIP), led by Dr. Neema Yazdanpanah, provides compounding pharmacy treatments to patients in Long Beach, Torrance, Los Angeles, South Bay Orange County, Southern California areas, and nationwide.
Pharmaceutical manufacturing and compounding are also legally quite different. Both manufacturing companies and compounding pharmacies have their own individual set of stipulations. In general, compounding pharmacies enjoy more legal freedom.
Compounding pharmacies as well as pharmaceutical manufacturing firms are overseen by governing agencies.
But pharmaceutical manufacturing companies come under the purview of the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) while compounding pharmacies are overseen by state licensing boards. This distinction is elaborated under section 503A of the FDCA.
In other words, this means that the doses, substances, and formulas compounding pharmacies use are technically not approved by the FDA. But this is more of a practical issue instead of one of reliability.
The FDA usually approves medications in very specific doses or formats while compounding pharmacies change these formats to address the patient’s individual requirements better.
While many compounding pharmacies lack FDA approval, it does not make them any less reliable. In the absence of exemptions from FDA-approval which can typically take between five to ten years for a single commercially available medication, compounding pharmacies would not be able to address custom drug needs.
However, exemptions enable compounders to quickly create predictable and reliable medication solutions for patients with drug sensitivities, allergies, and delicate medical conditions.
Are compounded medications safe?
Upon hearing that compounded drugs are not FDA-approved, people often get concerned about the reliability of these custom medicines. Registered and compounding pharmacies are overseen by state pharmacy licensing boards, as mentioned earlier.
These stipulations ensure that the compounding pharmacy uses safe substances, reliable methods and empirical evidence for the drugs they develop. Patients working with a licensed pharmacy can be assured that the medications are likely safe and reliable.
The Same Source
When medications are broken down to their base components, they are all virtually identical from a chemical point-of-view. Compounding pharmacies usually source their base ingredients from the same pharmaceutical manufacturing firms that produce commercial drugs.
The sole difference is that the compounding pharmacy combines or processes these substances in-house instead of simply receiving an injection, pill, topical, or pre-combined formula in a bottle or box.
Caring about the Patient
Similar to any other type of pharmacological treatment, not every drug is appropriate for every patient. The best way to ensure that a patient finds a safe and reliable treatment is to have a working relationship with their pharmacist and take an active role in their health.
AIP provides both traditional and modern compounding pharmacy solutions, including online prescription refills to patients in Long Beach, Torrance, Los Angeles, South Bay Orange County, Southern California areas, and nationwide.
American Integrative Pharmacy is located in Lomita, CA serving residents in and around Orange County, Los Angeles, Long Beach, Torrance and surrounding areas. Online prescription sales are available across the US.