In two previous articles regarding compounding, I have touched on the intersection of method-of-use patents and compounding, the FDA’s approach toward compounding pharmacies, and DUSA Pharmaceutical’s lawsuits against compounding pharmacies and unlicensed users of the methods that it patented. I’ve also outlined the sections of the code of federal regulations that provide the current legal framework for compounding pharmacies. In this article I would like to more fully explore recent developments in compounding law and put them into context.
It is important to recall that compounding of medications remains a large business in the United States. The National Association of Boards of Pharmacy estimates that pharmacy-made compounds account for 1% to 5% of all prescriptions.1
Dermatologists, who use a wide range of topical medications, have traditionally been among the most avid prescribers of compounded products. That is why it is important for us to understand the rules for distributing such products.1-4
Laws Remain in Flux
As I have outlined previously and will further explain in this article, the state of the law regarding compounding remains in flux with the FDA attempting to step up enforcement actions to prevent pharmacies from compounding medications and selling them for bulk purchases to doctors or patients. And on the other side of the issue is the courts, which generally continue reining in the authority of the FDA to regulate compounding. The laws regarding compounding have yet to reach an equilibrium point in legal world.
A Quick Primer on Compounding Law
It is important to understand the evolution of compounding law to a depth that my previous article did not plumb. Before 1997, 21 U.S.C 802 defined much of federal law on compounding. The law had a number of definitions.
Distribution is defined as “to deliver (other than by administering or dispensing) a controlled substance or listed chemical.” See 21 U.S.C. 802(11).
Dispense “means to deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling or compounding necessary to prepare the substance for delivery.” See 21 U.S.C. 802(10).
The law clearly permits pharmacies to compound controlled substances as part of the act of dispensing, and it exempts such compounding from the definition of manufacture.
The FD&C similarly exempts pharmacies that compound as part of retail pharmacy practice from the manufacturing requirements of that statute. However, in recent years some pharmacies have increased their compounding activities to such an extent that the FDA became concerned that some pharmacies are using compounding as a guise to manufacture drugs.3
In 1997 Congress passed the Food and Drug Administration Modernization Act of 1997, Pub. L. 105-115. 3 Included in the statute at Section 127 was a provision that amended the FD&C at 21 U.S.C. 353a. This provision was titled “Application of Federal Law to the Practice of Pharmacy Compounding,” which exempted pharmacies from drug approval provisions of the FD&C relating to manufacturing when they compounded drugs under certain circumstances.
The legislative history of this provision found in the House Conference Report stated that “[I]t is the intent of the conferees to ensure continued availability of compounded drug products as a component of individualized therapy, while limiting the scope of compounding so as to prevent manufacturing under the guise of compounding.” 1997 U.S.C.C.A.N. 2880.3
The Courts Are Challenged
Between 1999 and 2002 in the United States District Court for the District of Nevada, a number of compounding pharmacies challenged the constitutionality of the portion of the section that prohibited advertising of specific compounded drugs.3 The District Court found that the provision imposed an unconstitutional restriction on commercial speech, but held that the advertising provision was severable from the rest of the compounding provision (Western States Medical Center v. Shalala, 69 F.Supp.2d 1288 [D.Nev.1999]).
The United States Court of Appeals for the Ninth Circuit affirmed that decision, but it held that the advertising provision was not severable from the rest of the compounding provision (Western States Medical Center v. Shalala, 238 F.3d 1090 [9th Cir. 2001]).
Review was granted by the Supreme Court on the advertising issue but not on the severability issue. The Supreme Court found the advertising provision to be an unconstitutional restriction on commercial speech (Thompson v. Western States Medical Center, 535 U.S. 357 [2002]). The Court did not address the other provisions of the section.
Since the Supreme Court’s decision, the FDA has continued its efforts to curb compounding in bulk. The FDA has issued Compliance Policy Guides related to pharmacy compounding for both human and veterinary drugs. The Guides continue to express FDA’s concern that certain pharmacies are using their retail licenses to conduct manufacturing and distribution activities under the guise of compounding.
I have previously mentioned in my February 2006 column that the FDA issued a warning letter to the Respi Care Group of Puerto Rico effectively shutting Respi.
In 2006, the FDA went further still and closed a compounding pharmacy called Wedgewood Village Pharmacy in Sewell, NJ, which had been the subject of a 3-year investigation.3
On March 22, 2006, Deputy Administrator of the Drug Enforcement Administration found that “Wedgewood dispenses controlled substances to physicians for administration to their patients.”
Specifically, Wedgewood distributed identical products to many different individual practitioners and therefore not compounding on a patient-by-patient basis.
As a result, the DEA Certificate of Registration issued to Wedgewood Village Pharmacy was revoked effectively putting it out of business.
The Rights of Pharmacists Upheld
Although the FDA attempts to curb compounding, the courts have upheld the rights of pharmacies to compound medications of all sorts for individual patients.
On August 30, 2006, opinion of the United States District Court for the Western District of Texas in Medical Center Pharmacy v. Gonzales,2 held:
1. Lawfully compounded drugs for humans and for non-food-producing animals fall outside the definition of “new drugs” and “new animal drugs” under the Federal Food, Drug, and Cosmetic Act (“FDCA” or “the Act”).
2. Extemporaneous compounding of drugs is authorized under 21 U.S.C. § 353a (Section 503A of the FDCA) and such compounding is thereby exempted from the drug approval process and outside the scope of the definitions of “new drug” and “new animal drug” under sections 201(p)(1) and (v)(1) of the FDCA ( 21 U.S.C. § 321(p)(1) and (v)(1)).
3. FDA’s long-standing position that compounding from bulk ingredients of drugs for non-food-producing animals is illegal should be overturned.
Pharmacists’ Requirements
A few states have regulations requiring pharmacists to inform a patient when a compounded formulation is substituted for a manufactured product that is within the ambit of FDA law.1
For example, the Alaska Board of Pharmacy has stated that “both the patient and the prescribing practitioner [to] authorize the use of a compounded” preparation when it is being substituted for a manufactured product.
The Texas State Board of Pharmacy requires that pharmacies that outsource prescription dispensing, including compounded formulations must notify patients regardless if a substitution is made in the outpatient and community pharmacy settings, not in pharmacies in hospitals or nursing homes.
What Dermatologists Need to Know
Dermatologists who might distribute compounded medications need to understand the laws involved with compounding.
Simply put, pharmacists can compound most preparations for individual patients but cannot do so in bulk for prospective patients.
In two previous articles regarding compounding, I have touched on the intersection of method-of-use patents and compounding, the FDA’s approach toward compounding pharmacies, and DUSA Pharmaceutical’s lawsuits against compounding pharmacies and unlicensed users of the methods that it patented. I’ve also outlined the sections of the code of federal regulations that provide the current legal framework for compounding pharmacies. In this article I would like to more fully explore recent developments in compounding law and put them into context.
It is important to recall that compounding of medications remains a large business in the United States. The National Association of Boards of Pharmacy estimates that pharmacy-made compounds account for 1% to 5% of all prescriptions.1
Dermatologists, who use a wide range of topical medications, have traditionally been among the most avid prescribers of compounded products. That is why it is important for us to understand the rules for distributing such products.1-4
Laws Remain in Flux
As I have outlined previously and will further explain in this article, the state of the law regarding compounding remains in flux with the FDA attempting to step up enforcement actions to prevent pharmacies from compounding medications and selling them for bulk purchases to doctors or patients. And on the other side of the issue is the courts, which generally continue reining in the authority of the FDA to regulate compounding. The laws regarding compounding have yet to reach an equilibrium point in legal world.
A Quick Primer on Compounding Law
It is important to understand the evolution of compounding law to a depth that my previous article did not plumb. Before 1997, 21 U.S.C 802 defined much of federal law on compounding. The law had a number of definitions.
Distribution is defined as “to deliver (other than by administering or dispensing) a controlled substance or listed chemical.” See 21 U.S.C. 802(11).
Dispense “means to deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling or compounding necessary to prepare the substance for delivery.” See 21 U.S.C. 802(10).
The law clearly permits pharmacies to compound controlled substances as part of the act of dispensing, and it exempts such compounding from the definition of manufacture.
The FD&C similarly exempts pharmacies that compound as part of retail pharmacy practice from the manufacturing requirements of that statute. However, in recent years some pharmacies have increased their compounding activities to such an extent that the FDA became concerned that some pharmacies are using compounding as a guise to manufacture drugs.3
In 1997 Congress passed the Food and Drug Administration Modernization Act of 1997, Pub. L. 105-115. 3 Included in the statute at Section 127 was a provision that amended the FD&C at 21 U.S.C. 353a. This provision was titled “Application of Federal Law to the Practice of Pharmacy Compounding,” which exempted pharmacies from drug approval provisions of the FD&C relating to manufacturing when they compounded drugs under certain circumstances.
The legislative history of this provision found in the House Conference Report stated that “[I]t is the intent of the conferees to ensure continued availability of compounded drug products as a component of individualized therapy, while limiting the scope of compounding so as to prevent manufacturing under the guise of compounding.” 1997 U.S.C.C.A.N. 2880.3
The Courts Are Challenged
Between 1999 and 2002 in the United States District Court for the District of Nevada, a number of compounding pharmacies challenged the constitutionality of the portion of the section that prohibited advertising of specific compounded drugs.3 The District Court found that the provision imposed an unconstitutional restriction on commercial speech, but held that the advertising provision was severable from the rest of the compounding provision (Western States Medical Center v. Shalala, 69 F.Supp.2d 1288 [D.Nev.1999]).
The United States Court of Appeals for the Ninth Circuit affirmed that decision, but it held that the advertising provision was not severable from the rest of the compounding provision (Western States Medical Center v. Shalala, 238 F.3d 1090 [9th Cir. 2001]).
Review was granted by the Supreme Court on the advertising issue but not on the severability issue. The Supreme Court found the advertising provision to be an unconstitutional restriction on commercial speech (Thompson v. Western States Medical Center, 535 U.S. 357 [2002]). The Court did not address the other provisions of the section.
Since the Supreme Court’s decision, the FDA has continued its efforts to curb compounding in bulk. The FDA has issued Compliance Policy Guides related to pharmacy compounding for both human and veterinary drugs. The Guides continue to express FDA’s concern that certain pharmacies are using their retail licenses to conduct manufacturing and distribution activities under the guise of compounding.
I have previously mentioned in my February 2006 column that the FDA issued a warning letter to the Respi Care Group of Puerto Rico effectively shutting Respi.
In 2006, the FDA went further still and closed a compounding pharmacy called Wedgewood Village Pharmacy in Sewell, NJ, which had been the subject of a 3-year investigation.3
On March 22, 2006, Deputy Administrator of the Drug Enforcement Administration found that “Wedgewood dispenses controlled substances to physicians for administration to their patients.”
Specifically, Wedgewood distributed identical products to many different individual practitioners and therefore not compounding on a patient-by-patient basis.
As a result, the DEA Certificate of Registration issued to Wedgewood Village Pharmacy was revoked effectively putting it out of business.
The Rights of Pharmacists Upheld
Although the FDA attempts to curb compounding, the courts have upheld the rights of pharmacies to compound medications of all sorts for individual patients.
On August 30, 2006, opinion of the United States District Court for the Western District of Texas in Medical Center Pharmacy v. Gonzales,2 held:
1. Lawfully compounded drugs for humans and for non-food-producing animals fall outside the definition of “new drugs” and “new animal drugs” under the Federal Food, Drug, and Cosmetic Act (“FDCA” or “the Act”).
2. Extemporaneous compounding of drugs is authorized under 21 U.S.C. § 353a (Section 503A of the FDCA) and such compounding is thereby exempted from the drug approval process and outside the scope of the definitions of “new drug” and “new animal drug” under sections 201(p)(1) and (v)(1) of the FDCA ( 21 U.S.C. § 321(p)(1) and (v)(1)).
3. FDA’s long-standing position that compounding from bulk ingredients of drugs for non-food-producing animals is illegal should be overturned.
Pharmacists’ Requirements
A few states have regulations requiring pharmacists to inform a patient when a compounded formulation is substituted for a manufactured product that is within the ambit of FDA law.1
For example, the Alaska Board of Pharmacy has stated that “both the patient and the prescribing practitioner [to] authorize the use of a compounded” preparation when it is being substituted for a manufactured product.
The Texas State Board of Pharmacy requires that pharmacies that outsource prescription dispensing, including compounded formulations must notify patients regardless if a substitution is made in the outpatient and community pharmacy settings, not in pharmacies in hospitals or nursing homes.
What Dermatologists Need to Know
Dermatologists who might distribute compounded medications need to understand the laws involved with compounding.
Simply put, pharmacists can compound most preparations for individual patients but cannot do so in bulk for prospective patients.
In two previous articles regarding compounding, I have touched on the intersection of method-of-use patents and compounding, the FDA’s approach toward compounding pharmacies, and DUSA Pharmaceutical’s lawsuits against compounding pharmacies and unlicensed users of the methods that it patented. I’ve also outlined the sections of the code of federal regulations that provide the current legal framework for compounding pharmacies. In this article I would like to more fully explore recent developments in compounding law and put them into context.
It is important to recall that compounding of medications remains a large business in the United States. The National Association of Boards of Pharmacy estimates that pharmacy-made compounds account for 1% to 5% of all prescriptions.1
Dermatologists, who use a wide range of topical medications, have traditionally been among the most avid prescribers of compounded products. That is why it is important for us to understand the rules for distributing such products.1-4
Laws Remain in Flux
As I have outlined previously and will further explain in this article, the state of the law regarding compounding remains in flux with the FDA attempting to step up enforcement actions to prevent pharmacies from compounding medications and selling them for bulk purchases to doctors or patients. And on the other side of the issue is the courts, which generally continue reining in the authority of the FDA to regulate compounding. The laws regarding compounding have yet to reach an equilibrium point in legal world.
A Quick Primer on Compounding Law
It is important to understand the evolution of compounding law to a depth that my previous article did not plumb. Before 1997, 21 U.S.C 802 defined much of federal law on compounding. The law had a number of definitions.
Distribution is defined as “to deliver (other than by administering or dispensing) a controlled substance or listed chemical.” See 21 U.S.C. 802(11).
Dispense “means to deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling or compounding necessary to prepare the substance for delivery.” See 21 U.S.C. 802(10).
The law clearly permits pharmacies to compound controlled substances as part of the act of dispensing, and it exempts such compounding from the definition of manufacture.
The FD&C similarly exempts pharmacies that compound as part of retail pharmacy practice from the manufacturing requirements of that statute. However, in recent years some pharmacies have increased their compounding activities to such an extent that the FDA became concerned that some pharmacies are using compounding as a guise to manufacture drugs.3
In 1997 Congress passed the Food and Drug Administration Modernization Act of 1997, Pub. L. 105-115. 3 Included in the statute at Section 127 was a provision that amended the FD&C at 21 U.S.C. 353a. This provision was titled “Application of Federal Law to the Practice of Pharmacy Compounding,” which exempted pharmacies from drug approval provisions of the FD&C relating to manufacturing when they compounded drugs under certain circumstances.
The legislative history of this provision found in the House Conference Report stated that “[I]t is the intent of the conferees to ensure continued availability of compounded drug products as a component of individualized therapy, while limiting the scope of compounding so as to prevent manufacturing under the guise of compounding.” 1997 U.S.C.C.A.N. 2880.3
The Courts Are Challenged
Between 1999 and 2002 in the United States District Court for the District of Nevada, a number of compounding pharmacies challenged the constitutionality of the portion of the section that prohibited advertising of specific compounded drugs.3 The District Court found that the provision imposed an unconstitutional restriction on commercial speech, but held that the advertising provision was severable from the rest of the compounding provision (Western States Medical Center v. Shalala, 69 F.Supp.2d 1288 [D.Nev.1999]).
The United States Court of Appeals for the Ninth Circuit affirmed that decision, but it held that the advertising provision was not severable from the rest of the compounding provision (Western States Medical Center v. Shalala, 238 F.3d 1090 [9th Cir. 2001]).
Review was granted by the Supreme Court on the advertising issue but not on the severability issue. The Supreme Court found the advertising provision to be an unconstitutional restriction on commercial speech (Thompson v. Western States Medical Center, 535 U.S. 357 [2002]). The Court did not address the other provisions of the section.
Since the Supreme Court’s decision, the FDA has continued its efforts to curb compounding in bulk. The FDA has issued Compliance Policy Guides related to pharmacy compounding for both human and veterinary drugs. The Guides continue to express FDA’s concern that certain pharmacies are using their retail licenses to conduct manufacturing and distribution activities under the guise of compounding.
I have previously mentioned in my February 2006 column that the FDA issued a warning letter to the Respi Care Group of Puerto Rico effectively shutting Respi.
In 2006, the FDA went further still and closed a compounding pharmacy called Wedgewood Village Pharmacy in Sewell, NJ, which had been the subject of a 3-year investigation.3
On March 22, 2006, Deputy Administrator of the Drug Enforcement Administration found that “Wedgewood dispenses controlled substances to physicians for administration to their patients.”
Specifically, Wedgewood distributed identical products to many different individual practitioners and therefore not compounding on a patient-by-patient basis.
As a result, the DEA Certificate of Registration issued to Wedgewood Village Pharmacy was revoked effectively putting it out of business.
The Rights of Pharmacists Upheld
Although the FDA attempts to curb compounding, the courts have upheld the rights of pharmacies to compound medications of all sorts for individual patients.
On August 30, 2006, opinion of the United States District Court for the Western District of Texas in Medical Center Pharmacy v. Gonzales,2 held:
1. Lawfully compounded drugs for humans and for non-food-producing animals fall outside the definition of “new drugs” and “new animal drugs” under the Federal Food, Drug, and Cosmetic Act (“FDCA” or “the Act”).
2. Extemporaneous compounding of drugs is authorized under 21 U.S.C. § 353a (Section 503A of the FDCA) and such compounding is thereby exempted from the drug approval process and outside the scope of the definitions of “new drug” and “new animal drug” under sections 201(p)(1) and (v)(1) of the FDCA ( 21 U.S.C. § 321(p)(1) and (v)(1)).
3. FDA’s long-standing position that compounding from bulk ingredients of drugs for non-food-producing animals is illegal should be overturned.
Pharmacists’ Requirements
A few states have regulations requiring pharmacists to inform a patient when a compounded formulation is substituted for a manufactured product that is within the ambit of FDA law.1
For example, the Alaska Board of Pharmacy has stated that “both the patient and the prescribing practitioner [to] authorize the use of a compounded” preparation when it is being substituted for a manufactured product.
The Texas State Board of Pharmacy requires that pharmacies that outsource prescription dispensing, including compounded formulations must notify patients regardless if a substitution is made in the outpatient and community pharmacy settings, not in pharmacies in hospitals or nursing homes.
What Dermatologists Need to Know
Dermatologists who might distribute compounded medications need to understand the laws involved with compounding.
Simply put, pharmacists can compound most preparations for individual patients but cannot do so in bulk for prospective patients.
