This article, the second of a two-part series, is devoted to the discussion of drug compounding, an issue that is one of the key legal issues in the case that DUSA Pharmaceuticals (Wilmington, MA) has brought in recently suing several physicians. The company has sued several physicians who have allegedly been using aminolevulinic acid (ALA) obtained from private compounding pharmacies as a substitute for DUSA’s Levulan brand of ALA.
Several compounding pharmacies have already been sued regarding this issue. In 2004 and in early 2005, DUSA sued two compounding pharmacies, The Cosmetic Pharmacy of Tucson, AZ, and the New England Compounding Center in Framingham, MA, for violations of U.S. patent law.
The Cosmetic Pharmacy presented no defense against the suit, so a default judgment was entered by the court in DUSA’s favor. The court also took the unusual step of awarding attorney fees to DUSA. The suit against the New England Compounding Center is still pending.
The lawsuits allege that these compounding pharmacies were promoting their compounded ALA for use in DUSA’s patented therapies and were therefore inducing physicians to infringe DUSA’s patents.
When the FDA Gets Involved
The states regulate pharmacies, and FDA only gets involved if it is believed that a pharmacy has crossed the line of compounding and moved into the realm of manufacturing.
Pharmacists have run into problems with FDA when they mass compound drugs, which the agency views as drug manufacturing subject to new drug approvals. That’s especially true for an industry the FDA describes as “big and growing”, with more than 650 pharmacies across the country filling more than 13 million prescriptions annually for compounded drugs.
Unlike drugs made by regulated manufacturers, compounded medicines aren’t checked by the FDA for safety or effectiveness, and the federal government can’t require that the materials used in making them are genuine.
Federal law expressly permits compounding and puts it outside the ambit of the FDA for the most part. In addition, the Supreme Court has upheld the rights of compounding pharmacies to promote their products.
Legal Limits to Compounding
The following is from the code of federal regulations that pertains to compounding. The areas important in DUSA litigation are bolded.
SEC. 127. APPLICATION OF FEDERAL LAW TO PRACTICE OF PHARMACY COMPOUNDING.
SEC. 503A. PHARMACY COMPOUNDING.
“(a) In General: Sections 501(a)(2)(B), 502(f)(1), and 505 shall not apply to a drug product if the drug product is compounded for an identified individual patient based on the unsolicited receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient, if the drug product meets the requirements of this section, and if the compounding —
(1) is by —
(A) a licensed pharmacist in a State licensed pharmacy or a Federal facility, or
(B) a licensed physician, on the prescription order for such individual patient made by a licensed physician or other licensed practitioner authorized by State law to prescribe drugs; or
(2)(A) is by a licensed pharmacist or licensed physician in limited quantities before the receipt of a valid prescription order for such individual patient; and
(B) is based on a history of the licensed pharmacist or licensed physician receiving valid prescription orders for the compounding of the drug product, which orders have been generated solely within an established relationship between —
(i) the licensed pharmacist or licensed physician; and
(ii)(I) such individual patient for whom the prescription order will be provided; or
(II) the physician or other licensed practitioner who will write such prescription order.
(b) Compounded Drug.
(1) Licensed pharmacist and licensed physician. — A drug product may be compounded under subsection (a) if the licensed pharmacist or licensed physician —
(A) compounds the drug product using bulk drug substances, as defined in regulations of the Secretary published at section 207.3(a)(4) of title 21 of the Code of Federal Regulations—
(i) that —
(I) comply with the standards of an applicable United States Pharma-copoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding;
(II) if such a monograph does not exist, are drug substances that are components of drugs approved by the Secretary; or
(III) if such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, that appear on a list developed by the Secretary through regulations issued by the Secretary under subsection (d);
(ii) that are manufactured by an establishment that is registered under section 510 (including a foreign establishment that is registered under section 510(i)); and
(iii) that are accompanied by valid certificates of analysis for each bulk drug substance;
(B) compounds the drug product using ingredients (other than bulk drug substances) that comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding;
(C) does not compound a drug product that appears on a list published by the Secretary in the Federal Register of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective; and
(D) does not compound regularly or in inordinate amounts (as defined by the Secretary) any drug products that are essentially copies of a commercially available drug product.
(2) Definition. — For purposes of paragraph (1)(D), the term ‘essentially a copy of a commercially available drug product’ does not include a drug product in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug product.
(3) Drug product.— A drug product may be compounded under subsection (a) only if —
(A) such drug product is not a drug product identified by the Secretary by regulation as a drug product that presents demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product; and
(B) such drug product is compounded in a State —
(i) that has entered into a memorandum of understanding with the Secretary which addresses the distribution of inordinate amounts of compounded drug products interstate and provides for appropriate investigation by a State agency of complaints relating to compounded drug products distributed outside such State; or
(ii) that has not entered into the memorandum of understanding described in clause (i) and the licensed pharmacist, licensed pharmacy, or licensed physician distributes (or causes to be distributed) compounded drug products out of the State in which they are compounded in quantities that do not exceed 5 percent of the total prescription orders dispensed or distributed by such pharmacy or physician.”
Anatomy of One Lawsuit
The FDA has taken action against compounders who cross the line of compounding into the realm of manufacturing.
For example, in 2004, the FDA issued a warning letter to the Respi Care Group of Puerto Rico. In the letter, the FDA alerted the company that it had committed “serious violations” of the Federal Food, Drug, and Cosmetic Act.
Respi’s operation of manufacturing compounded inhalation solution products was more akin to that of a drug manufacturer, the FDA noted in its letter to Respi. Products made by Respi — albuterol sulfate and budesonide inhalation — were sold in the same strength as the commercially available products, according to the FDA.
In addition, since the start of Respi’s operation in 2002, Respi had produced volumes of inhalation solutions that were inconsistent with the activities of a pharmacy engaged in the traditional practice of extemporaneous pharmacy compounding.
The FDA specifically noted in its letter to Respi:
• Essentially, Respi has been producing copies of commercially available, FDA-approved drugs. Moreover, Respi continues to manufacture and distribute products “with virtually no regard to current good manufacturing practice requirements.”
Some of the specific violations listed in the letter included:
• inadequate labeling of products
• failure to establish and follow written procedures designed to prevent microbiological contamination of products
• failure to perform qualification studies on its steam sterilizer
• insufficient gowning of employees handling sterilized materials
• failure to assure conformance to sterility requirements for each batch of drug purporting to be sterile.
DUSA’s Lawsuits
In the DUSA case, pharmacies that have been compounding ALA have been doing so, according to court decisions, in bulk in violation of the federal laws prohibiting (1) manufacturing unregulated prescription medication, and (2) inducing physicians to violate patents.
Compounding is only allowed to fill a specific order and is not permitted to create unrequested stocks of medication. The pharmacies compounding ALA are preparing a patented product and, according to court decisions, violating DUSA’s patent rights and providing the basis for DUSA’s suit.
Recent court decisions, however, do not mean that DUSA will prevail in all cases. The case it won was a default judgement. It might be more difficult for DUSA to close down a pharmacy that forecfully contests a suit. The pharmacies can claim their preparations vary from DUSA’s patent formula and are tailored to the needs of specific patients or that DUSA’s patents are invalid.
The courts will have to assess these possible issues. However, I think that DUSA, at least as far the pharmacies making ALA are concerned, will prevail in its legal actions.
Compounding: Meeting a Need
As a dermatologist, you’re probably quite familiar with the concept of compounding because many dermatological preparations in the past were made by pharmacists.
Drug compounding is a process by which a pharmacist or doctor combines, mixes, or alters ingredients to create a medication tailored to the needs of an individual patient. Compounding is typically used to prepare medications that are not commercially available, such as medication for a patient who is allergic to an ingredient in a mass-produced product.
Compounding is also the practice of making drugs for customers who cannot take a drug in its commercial form. For instance, a child may have a difficult time swallowing a large pill, in which case a pharmacist may make the drug in the form of a lollipop. Sometimes patients are allergic to ingredients in commercial drugs so a pharmacist may compound a special version of the drug.
This article, the second of a two-part series, is devoted to the discussion of drug compounding, an issue that is one of the key legal issues in the case that DUSA Pharmaceuticals (Wilmington, MA) has brought in recently suing several physicians. The company has sued several physicians who have allegedly been using aminolevulinic acid (ALA) obtained from private compounding pharmacies as a substitute for DUSA’s Levulan brand of ALA.
Several compounding pharmacies have already been sued regarding this issue. In 2004 and in early 2005, DUSA sued two compounding pharmacies, The Cosmetic Pharmacy of Tucson, AZ, and the New England Compounding Center in Framingham, MA, for violations of U.S. patent law.
The Cosmetic Pharmacy presented no defense against the suit, so a default judgment was entered by the court in DUSA’s favor. The court also took the unusual step of awarding attorney fees to DUSA. The suit against the New England Compounding Center is still pending.
The lawsuits allege that these compounding pharmacies were promoting their compounded ALA for use in DUSA’s patented therapies and were therefore inducing physicians to infringe DUSA’s patents.
When the FDA Gets Involved
The states regulate pharmacies, and FDA only gets involved if it is believed that a pharmacy has crossed the line of compounding and moved into the realm of manufacturing.
Pharmacists have run into problems with FDA when they mass compound drugs, which the agency views as drug manufacturing subject to new drug approvals. That’s especially true for an industry the FDA describes as “big and growing”, with more than 650 pharmacies across the country filling more than 13 million prescriptions annually for compounded drugs.
Unlike drugs made by regulated manufacturers, compounded medicines aren’t checked by the FDA for safety or effectiveness, and the federal government can’t require that the materials used in making them are genuine.
Federal law expressly permits compounding and puts it outside the ambit of the FDA for the most part. In addition, the Supreme Court has upheld the rights of compounding pharmacies to promote their products.
Legal Limits to Compounding
The following is from the code of federal regulations that pertains to compounding. The areas important in DUSA litigation are bolded.
SEC. 127. APPLICATION OF FEDERAL LAW TO PRACTICE OF PHARMACY COMPOUNDING.
SEC. 503A. PHARMACY COMPOUNDING.
“(a) In General: Sections 501(a)(2)(B), 502(f)(1), and 505 shall not apply to a drug product if the drug product is compounded for an identified individual patient based on the unsolicited receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient, if the drug product meets the requirements of this section, and if the compounding —
(1) is by —
(A) a licensed pharmacist in a State licensed pharmacy or a Federal facility, or
(B) a licensed physician, on the prescription order for such individual patient made by a licensed physician or other licensed practitioner authorized by State law to prescribe drugs; or
(2)(A) is by a licensed pharmacist or licensed physician in limited quantities before the receipt of a valid prescription order for such individual patient; and
(B) is based on a history of the licensed pharmacist or licensed physician receiving valid prescription orders for the compounding of the drug product, which orders have been generated solely within an established relationship between —
(i) the licensed pharmacist or licensed physician; and
(ii)(I) such individual patient for whom the prescription order will be provided; or
(II) the physician or other licensed practitioner who will write such prescription order.
(b) Compounded Drug.
(1) Licensed pharmacist and licensed physician. — A drug product may be compounded under subsection (a) if the licensed pharmacist or licensed physician —
(A) compounds the drug product using bulk drug substances, as defined in regulations of the Secretary published at section 207.3(a)(4) of title 21 of the Code of Federal Regulations—
(i) that —
(I) comply with the standards of an applicable United States Pharma-copoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding;
(II) if such a monograph does not exist, are drug substances that are components of drugs approved by the Secretary; or
(III) if such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, that appear on a list developed by the Secretary through regulations issued by the Secretary under subsection (d);
(ii) that are manufactured by an establishment that is registered under section 510 (including a foreign establishment that is registered under section 510(i)); and
(iii) that are accompanied by valid certificates of analysis for each bulk drug substance;
(B) compounds the drug product using ingredients (other than bulk drug substances) that comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding;
(C) does not compound a drug product that appears on a list published by the Secretary in the Federal Register of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective; and
(D) does not compound regularly or in inordinate amounts (as defined by the Secretary) any drug products that are essentially copies of a commercially available drug product.
(2) Definition. — For purposes of paragraph (1)(D), the term ‘essentially a copy of a commercially available drug product’ does not include a drug product in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug product.
(3) Drug product.— A drug product may be compounded under subsection (a) only if —
(A) such drug product is not a drug product identified by the Secretary by regulation as a drug product that presents demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product; and
(B) such drug product is compounded in a State —
(i) that has entered into a memorandum of understanding with the Secretary which addresses the distribution of inordinate amounts of compounded drug products interstate and provides for appropriate investigation by a State agency of complaints relating to compounded drug products distributed outside such State; or
(ii) that has not entered into the memorandum of understanding described in clause (i) and the licensed pharmacist, licensed pharmacy, or licensed physician distributes (or causes to be distributed) compounded drug products out of the State in which they are compounded in quantities that do not exceed 5 percent of the total prescription orders dispensed or distributed by such pharmacy or physician.”
Anatomy of One Lawsuit
The FDA has taken action against compounders who cross the line of compounding into the realm of manufacturing.
For example, in 2004, the FDA issued a warning letter to the Respi Care Group of Puerto Rico. In the letter, the FDA alerted the company that it had committed “serious violations” of the Federal Food, Drug, and Cosmetic Act.
Respi’s operation of manufacturing compounded inhalation solution products was more akin to that of a drug manufacturer, the FDA noted in its letter to Respi. Products made by Respi — albuterol sulfate and budesonide inhalation — were sold in the same strength as the commercially available products, according to the FDA.
In addition, since the start of Respi’s operation in 2002, Respi had produced volumes of inhalation solutions that were inconsistent with the activities of a pharmacy engaged in the traditional practice of extemporaneous pharmacy compounding.
The FDA specifically noted in its letter to Respi:
• Essentially, Respi has been producing copies of commercially available, FDA-approved drugs. Moreover, Respi continues to manufacture and distribute products “with virtually no regard to current good manufacturing practice requirements.”
Some of the specific violations listed in the letter included:
• inadequate labeling of products
• failure to establish and follow written procedures designed to prevent microbiological contamination of products
• failure to perform qualification studies on its steam sterilizer
• insufficient gowning of employees handling sterilized materials
• failure to assure conformance to sterility requirements for each batch of drug purporting to be sterile.
DUSA’s Lawsuits
In the DUSA case, pharmacies that have been compounding ALA have been doing so, according to court decisions, in bulk in violation of the federal laws prohibiting (1) manufacturing unregulated prescription medication, and (2) inducing physicians to violate patents.
Compounding is only allowed to fill a specific order and is not permitted to create unrequested stocks of medication. The pharmacies compounding ALA are preparing a patented product and, according to court decisions, violating DUSA’s patent rights and providing the basis for DUSA’s suit.
Recent court decisions, however, do not mean that DUSA will prevail in all cases. The case it won was a default judgement. It might be more difficult for DUSA to close down a pharmacy that forecfully contests a suit. The pharmacies can claim their preparations vary from DUSA’s patent formula and are tailored to the needs of specific patients or that DUSA’s patents are invalid.
The courts will have to assess these possible issues. However, I think that DUSA, at least as far the pharmacies making ALA are concerned, will prevail in its legal actions.
Compounding: Meeting a Need
As a dermatologist, you’re probably quite familiar with the concept of compounding because many dermatological preparations in the past were made by pharmacists.
Drug compounding is a process by which a pharmacist or doctor combines, mixes, or alters ingredients to create a medication tailored to the needs of an individual patient. Compounding is typically used to prepare medications that are not commercially available, such as medication for a patient who is allergic to an ingredient in a mass-produced product.
Compounding is also the practice of making drugs for customers who cannot take a drug in its commercial form. For instance, a child may have a difficult time swallowing a large pill, in which case a pharmacist may make the drug in the form of a lollipop. Sometimes patients are allergic to ingredients in commercial drugs so a pharmacist may compound a special version of the drug.
This article, the second of a two-part series, is devoted to the discussion of drug compounding, an issue that is one of the key legal issues in the case that DUSA Pharmaceuticals (Wilmington, MA) has brought in recently suing several physicians. The company has sued several physicians who have allegedly been using aminolevulinic acid (ALA) obtained from private compounding pharmacies as a substitute for DUSA’s Levulan brand of ALA.
Several compounding pharmacies have already been sued regarding this issue. In 2004 and in early 2005, DUSA sued two compounding pharmacies, The Cosmetic Pharmacy of Tucson, AZ, and the New England Compounding Center in Framingham, MA, for violations of U.S. patent law.
The Cosmetic Pharmacy presented no defense against the suit, so a default judgment was entered by the court in DUSA’s favor. The court also took the unusual step of awarding attorney fees to DUSA. The suit against the New England Compounding Center is still pending.
The lawsuits allege that these compounding pharmacies were promoting their compounded ALA for use in DUSA’s patented therapies and were therefore inducing physicians to infringe DUSA’s patents.
When the FDA Gets Involved
The states regulate pharmacies, and FDA only gets involved if it is believed that a pharmacy has crossed the line of compounding and moved into the realm of manufacturing.
Pharmacists have run into problems with FDA when they mass compound drugs, which the agency views as drug manufacturing subject to new drug approvals. That’s especially true for an industry the FDA describes as “big and growing”, with more than 650 pharmacies across the country filling more than 13 million prescriptions annually for compounded drugs.
Unlike drugs made by regulated manufacturers, compounded medicines aren’t checked by the FDA for safety or effectiveness, and the federal government can’t require that the materials used in making them are genuine.
Federal law expressly permits compounding and puts it outside the ambit of the FDA for the most part. In addition, the Supreme Court has upheld the rights of compounding pharmacies to promote their products.
Legal Limits to Compounding
The following is from the code of federal regulations that pertains to compounding. The areas important in DUSA litigation are bolded.
SEC. 127. APPLICATION OF FEDERAL LAW TO PRACTICE OF PHARMACY COMPOUNDING.
SEC. 503A. PHARMACY COMPOUNDING.
“(a) In General: Sections 501(a)(2)(B), 502(f)(1), and 505 shall not apply to a drug product if the drug product is compounded for an identified individual patient based on the unsolicited receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient, if the drug product meets the requirements of this section, and if the compounding —
(1) is by —
(A) a licensed pharmacist in a State licensed pharmacy or a Federal facility, or
(B) a licensed physician, on the prescription order for such individual patient made by a licensed physician or other licensed practitioner authorized by State law to prescribe drugs; or
(2)(A) is by a licensed pharmacist or licensed physician in limited quantities before the receipt of a valid prescription order for such individual patient; and
(B) is based on a history of the licensed pharmacist or licensed physician receiving valid prescription orders for the compounding of the drug product, which orders have been generated solely within an established relationship between —
(i) the licensed pharmacist or licensed physician; and
(ii)(I) such individual patient for whom the prescription order will be provided; or
(II) the physician or other licensed practitioner who will write such prescription order.
(b) Compounded Drug.
(1) Licensed pharmacist and licensed physician. — A drug product may be compounded under subsection (a) if the licensed pharmacist or licensed physician —
(A) compounds the drug product using bulk drug substances, as defined in regulations of the Secretary published at section 207.3(a)(4) of title 21 of the Code of Federal Regulations—
(i) that —
(I) comply with the standards of an applicable United States Pharma-copoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding;
(II) if such a monograph does not exist, are drug substances that are components of drugs approved by the Secretary; or
(III) if such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, that appear on a list developed by the Secretary through regulations issued by the Secretary under subsection (d);
(ii) that are manufactured by an establishment that is registered under section 510 (including a foreign establishment that is registered under section 510(i)); and
(iii) that are accompanied by valid certificates of analysis for each bulk drug substance;
(B) compounds the drug product using ingredients (other than bulk drug substances) that comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding;
(C) does not compound a drug product that appears on a list published by the Secretary in the Federal Register of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective; and
(D) does not compound regularly or in inordinate amounts (as defined by the Secretary) any drug products that are essentially copies of a commercially available drug product.
(2) Definition. — For purposes of paragraph (1)(D), the term ‘essentially a copy of a commercially available drug product’ does not include a drug product in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug product.
(3) Drug product.— A drug product may be compounded under subsection (a) only if —
(A) such drug product is not a drug product identified by the Secretary by regulation as a drug product that presents demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product; and
(B) such drug product is compounded in a State —
(i) that has entered into a memorandum of understanding with the Secretary which addresses the distribution of inordinate amounts of compounded drug products interstate and provides for appropriate investigation by a State agency of complaints relating to compounded drug products distributed outside such State; or
(ii) that has not entered into the memorandum of understanding described in clause (i) and the licensed pharmacist, licensed pharmacy, or licensed physician distributes (or causes to be distributed) compounded drug products out of the State in which they are compounded in quantities that do not exceed 5 percent of the total prescription orders dispensed or distributed by such pharmacy or physician.”
Anatomy of One Lawsuit
The FDA has taken action against compounders who cross the line of compounding into the realm of manufacturing.
For example, in 2004, the FDA issued a warning letter to the Respi Care Group of Puerto Rico. In the letter, the FDA alerted the company that it had committed “serious violations” of the Federal Food, Drug, and Cosmetic Act.
Respi’s operation of manufacturing compounded inhalation solution products was more akin to that of a drug manufacturer, the FDA noted in its letter to Respi. Products made by Respi — albuterol sulfate and budesonide inhalation — were sold in the same strength as the commercially available products, according to the FDA.
In addition, since the start of Respi’s operation in 2002, Respi had produced volumes of inhalation solutions that were inconsistent with the activities of a pharmacy engaged in the traditional practice of extemporaneous pharmacy compounding.
The FDA specifically noted in its letter to Respi:
• Essentially, Respi has been producing copies of commercially available, FDA-approved drugs. Moreover, Respi continues to manufacture and distribute products “with virtually no regard to current good manufacturing practice requirements.”
Some of the specific violations listed in the letter included:
• inadequate labeling of products
• failure to establish and follow written procedures designed to prevent microbiological contamination of products
• failure to perform qualification studies on its steam sterilizer
• insufficient gowning of employees handling sterilized materials
• failure to assure conformance to sterility requirements for each batch of drug purporting to be sterile.
DUSA’s Lawsuits
In the DUSA case, pharmacies that have been compounding ALA have been doing so, according to court decisions, in bulk in violation of the federal laws prohibiting (1) manufacturing unregulated prescription medication, and (2) inducing physicians to violate patents.
Compounding is only allowed to fill a specific order and is not permitted to create unrequested stocks of medication. The pharmacies compounding ALA are preparing a patented product and, according to court decisions, violating DUSA’s patent rights and providing the basis for DUSA’s suit.
Recent court decisions, however, do not mean that DUSA will prevail in all cases. The case it won was a default judgement. It might be more difficult for DUSA to close down a pharmacy that forecfully contests a suit. The pharmacies can claim their preparations vary from DUSA’s patent formula and are tailored to the needs of specific patients or that DUSA’s patents are invalid.
The courts will have to assess these possible issues. However, I think that DUSA, at least as far the pharmacies making ALA are concerned, will prevail in its legal actions.
Compounding: Meeting a Need
As a dermatologist, you’re probably quite familiar with the concept of compounding because many dermatological preparations in the past were made by pharmacists.
Drug compounding is a process by which a pharmacist or doctor combines, mixes, or alters ingredients to create a medication tailored to the needs of an individual patient. Compounding is typically used to prepare medications that are not commercially available, such as medication for a patient who is allergic to an ingredient in a mass-produced product.
Compounding is also the practice of making drugs for customers who cannot take a drug in its commercial form. For instance, a child may have a difficult time swallowing a large pill, in which case a pharmacist may make the drug in the form of a lollipop. Sometimes patients are allergic to ingredients in commercial drugs so a pharmacist may compound a special version of the drug.
