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Generally, based on state law, the pharmacist must have all of the following elements in order to dispense a prescription:
- Date of prescription issue
- Practitioner's name, address, and license number
- Patient's name and address
- Date of birth
- Patient gender
- Allergies
- Current and relevant prior medications (e.g., prescription medications, OTCs, and herbal medications)
- Drug name
- Drug strength
- Dosage form
- Quantity prescribed
- Directions for use (Including route of administration if patient self-administers)
- Number of refills (if any) authorized
- The statement "This compounded product is necessary for the identified patient."
A pharmacist is required to have all of the prescription elements to dispense the prescription. Prescription elements not provided by the physician must be obtained from the patient or by contacting the physician, producing additional work which may possibly delay shipment of the prescription.
May I Write a Prescription for a Compounded Drug to Deliver to My Office vs. My Patient?
This depends on the state in which you are located. Some states allow a pharmacist to deliver a prescription to a physician's office and some do not. For the correct answer, you will need to call your state board of pharmacy.
I Typically Use One Vial of Medication in the Office for Multiple Patients. How Do I Write a Valid Prescription for This?
In general, state law requires the dispensing or administration of the prescribed compounded drug product to the patient identified on the prescription. The practice of sharing "office use" compounded drug products on multiple patients is no longer legal. For example, if a 10 mL vial of compounded drug is received on a prescription and only ½ of the contents is dispensed/administered to the patient over the course of treatment, the remaining contents must be discarded and may not be used for any other patient.
Please remember, commercially available drugs (those approved by the FDA) are available from drug wholesalers and may be ordered for office use in those states that allow for office use.
Can I Still Use a Multidose Vial for Multiple Patients?
No. A multidose vial may be administered only to the patient identified in the valid prescription.
How Does This Affect My Practice and Patients Economically?
There is no other way to say it but that the effect of 503A will increase the cost to you and your patients unless you have been writing prescriptions all along. The additional time required of the physician and staff to manage compounded drug prescriptions and compounded drug products within the office will increase. Additionally, it takes longer and costs more for the compounding pharmacy to process multiple patient prescriptions instead of one "office use" order.
Will I Be Able to Continue to Get All My Compounded Drugs?
Most, but not all. A pharmacy operating under 503A may compound bulk drug substances that:
- meet standards of an applicable USP or NF monograph or
- be a component of an approved drug or
- appear on a list developed by the secretary (FDA)
Many compounded drug products fall within the first three categories. What will appear on the secretary's (FDA) approved list is unknown at this time.
What's This About an Approved List of Pharmacies?
It is commonly misunderstood that because a pharmacy has voluntarily registered with the FDA as a 503B facility, it means that its facility or the drug products produced at the facility have been compounded in compliance with cGMP or have been inspected by the FDA. The FDA intends to inspect 503B Outsourcing Facilities utilizing a risk-based policy. A registered facility that has been inspected may have received a 483 inspection report identifying areas on noncompliance and may have received a Warning Letter. You may follow the current status of Outsourcing Facilities on the FDA's Outsourcing Facility website.14
Why Can't I Order My Compounded Drugs from an Outsourcing Facility Today?
Currently, an Outsourcing Facility may only produce commercial (FDA-approved) drugs that appear on the FDA's drug shortage list. Many of these drugs are of limited interest to physicians who normally prescribe individualized compounded drugs for their patients.
How Will the FDA-Approved Bulk Drug Substance List Affect My Practice?
When the FDA does publish the approved bulk drug substance list, the public will understand the intent of the FDA. If the 503A and 503B "approved" list includes most of the compounded drug products (2400 drug products have been submitted by International Academy of Compounding Pharmacists) submitted to Docket FDA-2013N-1524 for review, many of the compounded products that you currently prescribe will likely become available.15,16
How Will the FDA 'Do Not Compound' Lists Affect My Practice?
503A compounding pharmacy and 503B Outsourcing Facilities performance is also restricted by the FDA "do not compound" lists such as:
- drugs withdrawn or removed because unsafe or not effective
- drugs presenting demonstrable difficulties for compounding
On July 1, 2014, the FDA made 25 additions and 1 modification to the list of drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness.17 A list of compounded drugs presenting demonstrable difficulties for compounding pharmacy has not yet been created by the FDA.
With All the FDA Warning Letters to Compounding Pharmacies, Which Pharmacy Can I Trust?
Most 503A compounding pharmacies are not inspected by the FDA.
The best compounding pharmacies seek out independent third-party inspections and certification to demonstrate that the pharmacy is in conformance to state, national, and international law and regulatory requirements. This is expensive and time consuming for the pharmacy but yields dividends to physicians and patients, as they can rely on the due diligence of independent inspections and certifications. Independent third-party accreditation and certification authorities are:
- Pharmacy Compounding Accreditation Board (PCAB)18
- National Association of Boards of Pharmacy, Verified Pharmacy Program (VPP)19
- International Standards Organization, ISO9001, 200820
Why Do I Have to Write a Prescription for Compounded Drugs but Not for Commercial Drugs?
We believe that regulatory thinking behind the prescription requirement is to restrict order volume by creating a complex order processing structure to eliminate the "mass ordering" business model used by the New England Compounding Center. However, we believe that there are other methodologies available to identify and evaluate mass ordering that are less expensive and less invasive.
What is it about a prescription that protects a patient to a greater degree than an office use order? The answer may be, not much, and therefore calls into question the continued insistence for a prescription requirement. The FDA indicates that off-label use of commercial drugs is appropriate under the following conditions:
Good medical practice and the best interests of the patient require that physicians use legally available [NDA and ANDA approved commercial] drugs, biologics and devices according to their best knowledge and judgment. If physicians use a product for an indication not in the approved labeling [i.e. known as Off-Label prescribing and use], they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects.21
Generally, compounded drugs are not FDA approved. The FDA does not verify the safety or effectiveness of compounded drugs, nor does it verify the safety or effectiveness of commercial drugs used for off-label indications.22 Further, compounded drugs are made from active pharmaceutical ingredients and ingredients found in commercially available drugs and/or USP monographs that reduce patient risk. This increases the similarity of approved drugs used for off-label indications and compounded drugs.
If a physician fulfills the responsibility to be well informed about the drug product, to base the drug products use on firm scientific rationale and on sound medical evidence, why should the two drug products, one commercial and one compounded, differ in the method used to order and deliver the product?
Moving Forward … and What You Can Do.
Unintended consequences; unknown FDA intent; conflict between federal and state law: all combine to create an unstable business/healthcare environment with unnecessary added costs and time wasted by stakeholders.
Unfortunately, our federal lawmakers chose to revive 1997 expertise to meet 2014 needs. 503A has proved to be flawed and is not appropriate for today's health-care environment. 503A smothers the physician's ability to administer the most effective drugs to his or her patient. Reviving 503A has done little to address the root cause of sterility and quality control failures raised by the New England Compounding Center meningitis outbreak of 2012.
An area that may limit the number of compounded drugs available to physicians is the possibility for the FDA to limit bulk drug substances on the "approved list." An important method to increase the number of compounded drugs available to physicians is to increase the number of USP monographs.
The US Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines distributed and consumed worldwide.23 The USP also has monographs that apply to compounding, including compounded preparation monographs that include directions for compounding the preparation, its packaging and storage requirements, and beyond-use dates.24
Simply stated, the more monographs the USP produces, the more compounded drug products will be available. The USP is independent of the FDA, and pharmacists may compound drugs using bulk drug substances that have an appropriate USP monograph. Physicians, patients, pharmacists, and other stakeholders are valued partners to the USP and have previously collaborated to create public standards such as USP monographs.25
As physicians, pharmacists, and patients, we have a vested interest in the USP's ability to update and develop compounding and other monographs because those monographs are a vital part of our ability to access quality medications. The USP needs us, and by helping the USP we help ourselves. Information, expertise, and insights that you already have can support these efforts:
Also, join Alliance for Natural Health (ANH-USA), a grassroots consumer advocacy organization. ANH-USA carefully tracks proposed legislation and regulations, then informs physicians and consumers and offers a means to take action.26
Make your federal legislators aware of your thoughts about DQSA and how it affects your business, your patients, and health care. Suggest changes such as allowing for office use orders. They do listen. To find your representative, go to http://www.contactingthecongress.org.
We are all on this adventure together, whether you are a physician, pharmacist, patient, or entrepreneur. We all want to build value and contribute to better health care. Our best chance to create a sustainable, value-added, physician, pharmacist, patient compounding solution is to take action and press for appropriate change.
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