A. The Board shall regulate the practice of pharmacy and the manufacturing,dispensing, selling, distributing, processing, compounding, or disposal ofdrugs and devices. The Board shall also control the character and standard ofall drugs, cosmetics and devices within the Commonwealth, investigate allcomplaints as to the quality and strength of all drugs, cosmetics, anddevices and take such action as may be necessary to prevent themanufacturing, dispensing, selling, distributing, processing, compounding anddisposal of such drugs, cosmetics and devices that do not conform to therequirements of law.
The Board's regulations shall include criteria for:
1. Maintenance of the quality, quantity, integrity, safety and efficacy ofdrugs or devices distributed, dispensed or administered.
2. Compliance with the prescriber's instructions regarding the drug, itsquantity, quality and directions for use.
3. Controls and safeguards against diversion of drugs or devices.
4. Maintenance of the integrity of, and public confidence in, the professionand improving the delivery of quality pharmaceutical services to the citizensof Virginia.
5. Maintenance of complete records of the nature, quantity or quality ofdrugs or substances distributed or dispensed, and of all transactionsinvolving controlled substances or drugs or devices so as to provide adequateinformation to the patient, the practitioner or the Board.
6. Control of factors contributing to abuse of legitimately obtained drugs,devices, or controlled substances.
7. Promotion of scientific or technical advances in the practice of pharmacyand the manufacture and distribution of controlled drugs, devices orsubstances.
8. Impact on costs to the public and within the health care industry throughthe modification of mandatory practices and procedures not essential tomeeting the criteria set out in subdivisions 1 through 7 of this section.
9. Such other factors as may be relevant to, and consistent with, the publichealth and safety and the cost of rendering pharmacy services.
B. The Board's regulations to implement the criteria set forth in subsectionA shall include, but shall not be limited to, the establishment andimplementation of a pedigree system, as defined in subsection D. The Boardshall structure the implementation of the pedigree with limited applicationto certain schedules or certain drugs, upon finding that such drugs are moresubject to counterfeiting. In order to maintain a current and appropriatelist of drugs susceptible to counterfeiting, the Board may amend such list inits regulations. Such amendments to the list shall be exempt from therequirements of Article 2 (§ 2.2-4006 et seq.) of the Administrative ProcessAct. The Board shall establish in regulation a process for amending such listthat provides notice and opportunity for public comment. The Board shalllimit the implementation of a pedigree system to those drugs that have leftthe normal distribution channel as defined in subsection D. The pedigreeshall also satisfy the requirements of 21 U.S.C. § 353(e), regardingrequirements for wholesale distributors of drugs in interstate commerce. TheBoard may provide for exceptions to the pedigree requirements of this sectionfor emergency medical reasons as defined in regulation.
C. The Board may collect and examine specimens of drugs, devices andcosmetics that are manufactured, distributed, stored or dispensed in theCommonwealth.
D. For the purposes of this section:
"Normal distribution channel" means a chain of custody for a prescriptiondrug from initial sale by a pharmaceutical manufacturer, through acquisitionand sale by one wholesale distributor as defined in § 54.1-3401, that is notexempted pursuant to § 54.1-3401.1, until sale to a pharmacy or other persondispensing or administering the controlled substance; or a chain of custodyfor a prescription drug from initial sale by a pharmaceutical manufacturer,through acquisition and sale by one wholesale distributor as defined in §54.1-3401, that is not exempted pursuant to § 54.1-3401.1, to a chainpharmacy warehouse to its intracompany pharmacies; or a chain of custody fora prescription drug from initial sale by a pharmaceutical manufacturer to achain pharmacy warehouse to its intracompany pharmacies.
"Pedigree" means a paper document or electronic file recording eachdistribution of a controlled substance from sale by a pharmaceuticalmanufacturer through acquisition and sale by any wholesale distributor, asdefined in § 54.1-3401 and not exempted pursuant to § 54.1-3401.1, until saleto a pharmacy or other person dispensing or administering the controlledsubstance. Returns from a pharmacy to the originating wholesale distributoror pharmaceutical manufacturer shall not be subject to the pedigreerequirements of this section.
(Code 1950, §§ 54-415, 54-416.1; 1954, c. 396; 1958, c. 551, § 54-524.16;1970, c. 650, § 54-524.18; 1972, c. 798; 1980, c. 288; 1988, c. 765; 1995, c.529; 1996, cc. 37, 407; 2005, c. 777; 2006, c. 632.)
A. The Board shall regulate the practice of pharmacy and the manufacturing,dispensing, selling, distributing, processing, compounding, or disposal ofdrugs and devices. The Board shall also control the character and standard ofall drugs, cosmetics and devices within the Commonwealth, investigate allcomplaints as to the quality and strength of all drugs, cosmetics, anddevices and take such action as may be necessary to prevent themanufacturing, dispensing, selling, distributing, processing, compounding anddisposal of such drugs, cosmetics and devices that do not conform to therequirements of law.
The Board's regulations shall include criteria for:
1. Maintenance of the quality, quantity, integrity, safety and efficacy ofdrugs or devices distributed, dispensed or administered.
2. Compliance with the prescriber's instructions regarding the drug, itsquantity, quality and directions for use.
3. Controls and safeguards against diversion of drugs or devices.
4. Maintenance of the integrity of, and public confidence in, the professionand improving the delivery of quality pharmaceutical services to the citizensof Virginia.
5. Maintenance of complete records of the nature, quantity or quality ofdrugs or substances distributed or dispensed, and of all transactionsinvolving controlled substances or drugs or devices so as to provide adequateinformation to the patient, the practitioner or the Board.
6. Control of factors contributing to abuse of legitimately obtained drugs,devices, or controlled substances.
7. Promotion of scientific or technical advances in the practice of pharmacyand the manufacture and distribution of controlled drugs, devices orsubstances.
8. Impact on costs to the public and within the health care industry throughthe modification of mandatory practices and procedures not essential tomeeting the criteria set out in subdivisions 1 through 7 of this section.
9. Such other factors as may be relevant to, and consistent with, the publichealth and safety and the cost of rendering pharmacy services.
B. The Board's regulations to implement the criteria set forth in subsectionA shall include, but shall not be limited to, the establishment andimplementation of a pedigree system, as defined in subsection D. The Boardshall structure the implementation of the pedigree with limited applicationto certain schedules or certain drugs, upon finding that such drugs are moresubject to counterfeiting. In order to maintain a current and appropriatelist of drugs susceptible to counterfeiting, the Board may amend such list inits regulations. Such amendments to the list shall be exempt from therequirements of Article 2 (§ 2.2-4006 et seq.) of the Administrative ProcessAct. The Board shall establish in regulation a process for amending such listthat provides notice and opportunity for public comment. The Board shalllimit the implementation of a pedigree system to those drugs that have leftthe normal distribution channel as defined in subsection D. The pedigreeshall also satisfy the requirements of 21 U.S.C. § 353(e), regardingrequirements for wholesale distributors of drugs in interstate commerce. TheBoard may provide for exceptions to the pedigree requirements of this sectionfor emergency medical reasons as defined in regulation.
C. The Board may collect and examine specimens of drugs, devices andcosmetics that are manufactured, distributed, stored or dispensed in theCommonwealth.
D. For the purposes of this section:
"Normal distribution channel" means a chain of custody for a prescriptiondrug from initial sale by a pharmaceutical manufacturer, through acquisitionand sale by one wholesale distributor as defined in § 54.1-3401, that is notexempted pursuant to § 54.1-3401.1, until sale to a pharmacy or other persondispensing or administering the controlled substance; or a chain of custodyfor a prescription drug from initial sale by a pharmaceutical manufacturer,through acquisition and sale by one wholesale distributor as defined in §54.1-3401, that is not exempted pursuant to § 54.1-3401.1, to a chainpharmacy warehouse to its intracompany pharmacies; or a chain of custody fora prescription drug from initial sale by a pharmaceutical manufacturer to achain pharmacy warehouse to its intracompany pharmacies.
"Pedigree" means a paper document or electronic file recording eachdistribution of a controlled substance from sale by a pharmaceuticalmanufacturer through acquisition and sale by any wholesale distributor, asdefined in § 54.1-3401 and not exempted pursuant to § 54.1-3401.1, until saleto a pharmacy or other person dispensing or administering the controlledsubstance. Returns from a pharmacy to the originating wholesale distributoror pharmaceutical manufacturer shall not be subject to the pedigreerequirements of this section.
(Code 1950, §§ 54-415, 54-416.1; 1954, c. 396; 1958, c. 551, § 54-524.16;1970, c. 650, § 54-524.18; 1972, c. 798; 1980, c. 288; 1988, c. 765; 1995, c.529; 1996, cc. 37, 407; 2005, c. 777; 2006, c. 632.)
A. The Board shall regulate the practice of pharmacy and the manufacturing,dispensing, selling, distributing, processing, compounding, or disposal ofdrugs and devices. The Board shall also control the character and standard ofall drugs, cosmetics and devices within the Commonwealth, investigate allcomplaints as to the quality and strength of all drugs, cosmetics, anddevices and take such action as may be necessary to prevent themanufacturing, dispensing, selling, distributing, processing, compounding anddisposal of such drugs, cosmetics and devices that do not conform to therequirements of law.
The Board's regulations shall include criteria for:
1. Maintenance of the quality, quantity, integrity, safety and efficacy ofdrugs or devices distributed, dispensed or administered.
2. Compliance with the prescriber's instructions regarding the drug, itsquantity, quality and directions for use.
3. Controls and safeguards against diversion of drugs or devices.
4. Maintenance of the integrity of, and public confidence in, the professionand improving the delivery of quality pharmaceutical services to the citizensof Virginia.
5. Maintenance of complete records of the nature, quantity or quality ofdrugs or substances distributed or dispensed, and of all transactionsinvolving controlled substances or drugs or devices so as to provide adequateinformation to the patient, the practitioner or the Board.
6. Control of factors contributing to abuse of legitimately obtained drugs,devices, or controlled substances.
7. Promotion of scientific or technical advances in the practice of pharmacyand the manufacture and distribution of controlled drugs, devices orsubstances.
8. Impact on costs to the public and within the health care industry throughthe modification of mandatory practices and procedures not essential tomeeting the criteria set out in subdivisions 1 through 7 of this section.
9. Such other factors as may be relevant to, and consistent with, the publichealth and safety and the cost of rendering pharmacy services.
B. The Board's regulations to implement the criteria set forth in subsectionA shall include, but shall not be limited to, the establishment andimplementation of a pedigree system, as defined in subsection D. The Boardshall structure the implementation of the pedigree with limited applicationto certain schedules or certain drugs, upon finding that such drugs are moresubject to counterfeiting. In order to maintain a current and appropriatelist of drugs susceptible to counterfeiting, the Board may amend such list inits regulations. Such amendments to the list shall be exempt from therequirements of Article 2 (§ 2.2-4006 et seq.) of the Administrative ProcessAct. The Board shall establish in regulation a process for amending such listthat provides notice and opportunity for public comment. The Board shalllimit the implementation of a pedigree system to those drugs that have leftthe normal distribution channel as defined in subsection D. The pedigreeshall also satisfy the requirements of 21 U.S.C. § 353(e), regardingrequirements for wholesale distributors of drugs in interstate commerce. TheBoard may provide for exceptions to the pedigree requirements of this sectionfor emergency medical reasons as defined in regulation.
C. The Board may collect and examine specimens of drugs, devices andcosmetics that are manufactured, distributed, stored or dispensed in theCommonwealth.
D. For the purposes of this section:
"Normal distribution channel" means a chain of custody for a prescriptiondrug from initial sale by a pharmaceutical manufacturer, through acquisitionand sale by one wholesale distributor as defined in § 54.1-3401, that is notexempted pursuant to § 54.1-3401.1, until sale to a pharmacy or other persondispensing or administering the controlled substance; or a chain of custodyfor a prescription drug from initial sale by a pharmaceutical manufacturer,through acquisition and sale by one wholesale distributor as defined in §54.1-3401, that is not exempted pursuant to § 54.1-3401.1, to a chainpharmacy warehouse to its intracompany pharmacies; or a chain of custody fora prescription drug from initial sale by a pharmaceutical manufacturer to achain pharmacy warehouse to its intracompany pharmacies.
"Pedigree" means a paper document or electronic file recording eachdistribution of a controlled substance from sale by a pharmaceuticalmanufacturer through acquisition and sale by any wholesale distributor, asdefined in § 54.1-3401 and not exempted pursuant to § 54.1-3401.1, until saleto a pharmacy or other person dispensing or administering the controlledsubstance. Returns from a pharmacy to the originating wholesale distributoror pharmaceutical manufacturer shall not be subject to the pedigreerequirements of this section.
(Code 1950, §§ 54-415, 54-416.1; 1954, c. 396; 1958, c. 551, § 54-524.16;1970, c. 650, § 54-524.18; 1972, c. 798; 1980, c. 288; 1988, c. 765; 1995, c.529; 1996, cc. 37, 407; 2005, c. 777; 2006, c. 632.)
