Accuracy in drug prescriptions has become a priority in recent years, especially with the outbreak of prescription drug abuse. Because of this, more people are turning to compounding pharmacies to ensure that they are receiving the right amount and dosage of prescribed medication. It is in this light that the U.S. Food and Drug Administration (FDA) recently announced updates to existing regulations involving compounding pharmacies.
What You Need To Know About Compounding Pharmacy Policy Updates
The 2018 Compounding Policy Priorities Plan provides a comprehensive layout of how key aspects will be implemented. It includes changes to some proposed policies to make sure that compounded drugs for patients whose needs cannot be met by conventional mass-market drug stores will not cause harm.
As part of this year’s plans and priorities for compounding pharmacies, the FDA encourages more compounding pharmacies to register under the 340B Drug Pricing Program. Facilities covered by this program are able to procure drugs in bulk supply, subject to more stringent safety standards.
The agency deemed it important to focus on the drug’s efficacy while reducing costs so that more compounding pharmacies will meet the higher production standards for 503B outsourcing facilities. As a result, more patients can have access to higher quality compounded medicines.
Additionally, the FDA would like to reiterate that the necessity of compounded medication should only be an alternative to meet the needs of patients whose medical needs cannot be met by an FDA-approved drug. There is a need to examine compounded medications to ensure that copying of existing medications is avoided.
Another goal is to include refining the regulations for communications with the states. This is with regards to the Memorandum of Understanding (between the FDA and individual states) geared towards addressing issues with the ability of the 503A compounding pharmacies to ship across different states lines. 503A compounding pharmacies are smaller facilities that are only able to compound for patient-specific cases.
With the 2018 regulations, 503A pharmacies should be able to ship across state lines provided that more than 50% of their drugs remain within the state.
Similarly, the FDA is allowing the states more time to report issues such as relying on inspection records that would help identify pharmacies that are shipping more than the allowable amount of compounded medications across state lines.
FDA Regulations for Compounding Pharmacies
This plan has been made in pursuit of implementing the federal law of compounding and to advance the FDA’s public health mission. This should help recognize the value of the compounder’s role in providing quality drugs so that patients can have access to the medicines that they need.
The following are the key features of the Compounding Policy Priorities Plan, based on the FDA announcement:
Risk-Based Approach to Manufacturing Standards for Outsourcing Facilities
The Federal Food, Drug, and Cosmetic Act is responsible for two types of compounding pharmacies:
- 503A: These include state-licensed pharmacies (or compounding pharmacies) that develop compound drugs with patient-specific prescriptions. They are referred to as “503A facilities” or traditional compounders.
- 503B: This is the new category of compounders that operate according to heightened stator requirements relative to the 503A facilities.
Drugs that are produced by the outsourcing facilities must be compounded in compliance with current good manufacturing practice requirements and performed in an FDA-approved facility subject to risk-based inspections. It is also important for the outsourcing facilities to provide information on the compounded products to the FDA.
The proposed regulations should cover how cGMP requirements should be applied regarding the size and scope of an outsourcing facility’s operations. Therefore, smaller compounders that compound only limited volumes of drugs may decide to register as outsourcing facilities, as a response to these new policies. This would allow them to compound drugs with or without patient-specific prescriptions under section 503B.
Restricting Compounding of Drugs that are Essentially Copies of FDA-Approved Drugs
Despite the acceptance of the usage of compounded medications, restrictions on the potential of copying FDA-approved or commercially available products should be put in place. Therefore, the law provisions are aimed to protect both public health and the premarket approval process. These restrictions prevent drug compounding for patients who can already find their medication in FDA-approved products.
Here are some highlights of this particular provision:
- The premarket inspection should be implemented to safeguard the regulatory standard for compounded drugs, which should only be distributed if no FDA-approved products are available for the patient.
- Due to the possibility of pharmacy compounding labs copying FDA-approved drugs, this policy is also aimed at protecting conventional drug manufacturers so that they may pursue research and development for the improvement of their existing products. Sponsors are less likely to invest in and seek approval of life-saving medications if compounders could easily develop substitutes that are less expensive.
Regulating Compounding from Bulk Drug Substances
Traditional compounders (i.e. 503A) are allowed to compound drugs in accordance with the FC&C Act using bulk drug substances that comply with the existing United States Pharmacopeia or National Formulary monograph standards. Meanwhile, outsourcing facilities (i.e 503B) may use bulk drug substances to compound a drug that complies similarly with the FD&C Act, if the FDA has determined that there is a clinical need to compound the drugs.
These policies were designed to address the ambiguity involving bulk drug substances by 503A and 503B facilities within the timeframe of substance evaluation before approval for compounding. During this period – for nominated substances consistent with the 503A or 503B interim policies, that is – there will be no clear distinction that a particular drug belongs to either 503A or 503B bulks list.
More highlights regarding this section include the following:
- With regards to the 503A bulk list, 48 substances were nominated to the Pharmacy Compounding Advisory Committee. The FDA issued a proposed regulation to address 10 of these substances and to create the criteria for evaluating these substances before inclusion to the list.
- In March 2018, the agency issued a draft that proposes criteria for making clinical determinations to make it possible for the substances to be included in the existing 503B bulk list.
Solidifying FDA’s Partnership with State Regulatory Authorities
The FDA is working closely with state partners to assure that they are able to address the risks that may be presented by compounded drugs. The objective is to focus on FDA resources (for both outsourcing facilities and traditional compounders) that may present huge risks.
Some of the important pointers in this section are as follows:
- The MOU between FDA and the states regarding compounding under section 503A will be revised as a result of the overwhelming response of the public to the previous MOU draft.
- The draft MOU states the percentage of compounded drugs that could be shipped interstate by 503A compounders. If a pharmacy distributes in an “inordinate amount”, the state would agree to take action (Inordinate amount denotes at least 30% of all drug products dispensed or distributed in a given month).
- The new document makes it more flexible for states to enter into the MOU by providing more time to report to the FDA, particularly in identifying inordinate amounts shipped.
Finalization of Biological Products Guidance and Clarifying Other Policies on Activities that Compounders Undertake
This final guidance covers the following:
- Provision of a mechanism for outsourcing facilities to assign beyond use dates to repackaged biological products that exceed the default BUDs of 24 hours
- More flexible approach to support patients and their clinicians
- Clarification of policies that are applicable to compounding by outsourcing facilities
- Addition or modification to the list of drug products that cannot be compounded (because the products or their components have been removed from the market either for safety or effectiveness)
Compliance with the regulation should be strictly monitored, particularly ensuring that only sterile compounded medications will reach patients to avoid any potential health risks.